This information collection request captures the requirements of Section 505 of the Food, Drug, and Cosmetic Act, which requires that a new drug may not be marketed unless the manufacture provides FDA with scientific evidence that the drug is both safe and effective. The regulations at 21 CFR Part 314 provide the means through which pharmaceutical manufacturers can obtain FDA approval of a drug product marketing application, and the means through which FDA can assure the safety and effectiveness of the marketed products. 2014-09-30-04:00 Active Eliazabeth Berbakos 3018271482 No No No 70315 3466039 0

314.50 (a), (b), (c), (d), (e), (f), and (k) No Health Public Health Monitoring Private Sector 92 241542 0

314.50(i) and 314.94(a)(12) No Health Public Health Monitoring Private Sector 923 1846 0

314.50(j) No Health Public Health Monitoring Private Sector 285 572 0

314.52 and 314.95 No Health Public Health Monitoring Private Sector 260 4160 0

314.60 No Health Public Health Monitoring Private Sector 7564 605120 0

314.65 No Health Public Health Monitoring Private Sector 12 24 0

314.70 and 314.71 No Health Public Health Monitoring Private Sector 3050 457500 0

314.72 No Health Public Health Monitoring Private Sector 310 620 0

314.81(b)(1) [3331] No Health Public Health Monitoring Private Sector 378 3024 0

314.81(b)(2) [2252] No Health Public Health Monitoring Private Sector 8149 362892 0

314.81(b)(3)(i) [2253] No Health Public Health Monitoring Private Sector 30130 60260 0

314.94(a)(1)-(11) and (d) No Health Public Health Monitoring Private Sector 862 413760 0

314.96 No Health Public Health Monitoring Private Sector 10461 836880 0

314.97 No Health Public Health Monitoring Private Sector 5169 413520 0

314.99(a) No Health Public Health Monitoring Private Sector 122 244 0

314.101(a) No Health Public Health Monitoring Private Sector 1 1 0

314.107(c) No Health Public Health Monitoring Private Sector 230 115 0

314.107(e) No Health Public Health Monitoring Private Sector 98 49 0

314.107(f) No Health Public Health Monitoring Private Sector 230 115 0

314.110(a)(5) No Health Public Health Monitoring Private Sector 1 1 0

314.110(c) No Health Public Health Monitoring Private Sector 15 8 0

314.420 No Health Public Health Monitoring Private Sector 1038 63318 0

Guidance; Reports on the Status of Postmarketing Studies/Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 No Health Health Care Services Private Sector 935 468 0

2011-09-05-04:00

0910-0014 201105-0910-011 0910
             
        "Investigational New Drug Regulations"
             
          
        
Information collection from applicants who apply for approval of an investigational new drug application in order to develop a drug for marketing. 2015-04-30-04:00 Active Eliazabeth Berbakos 3018271482 No No No 2685772 141870849 0

312.2(e) Request for advice on applicability of part 312 No Health Consumer Health and Safety Private Sector 469 11256 0

312.10 Applications for waiver of requirements under part 312 No Health Consumer Health and Safety Private Sector 4 40 0

312.23 Investigational New Drug submission No Health Consumer Health and Safety Private Sector 3145 5032000 0

312.30(a)-(e) Protocol Amendments No Health Consumer Health and Safety Private Sector 18079 5134436 0

312.31(b) Information Amendments No Health Public Health Monitoring Private Sector 454 45400 0

312.32(c)-(d) Safety Reports No Health Public Health Monitoring Private Sector 22713 726816 0

312.33 Annual Reports No Health Public Health Monitoring Private Sector 6000 2160000 0

312.8 Charging for investigational drugs under an IND No Health Public Health Monitoring Private Sector 34 1632 0

312.310(b) and 312.305(b) Submissions related to expanded access and treatment of an individual No Health Public Health Monitoring Private Sector 988 7904 0

312.38(b)(c) Notification of withdrawal of an IND No Health Public Health Monitoring Private Sector 874 24472 0

312.42(e) Request to remove clinical hold No Health Public Health Monitoring Private Sector 164 46576 0

312.44(c)(d) Response to termination of IND No Health Public Health Monitoring Private Sector 44 704 0

312.45(a)(b) Request for or response to inactive status determination No Health Public Health Monitoring Private Sector 362 4344 0

312.47(b) End-of-Phase 2 and Pre-NDA meetings No Health Public Health Monitoring Private Sector 506 80960 0

312.53(c) Investigator Information No Health Public Health Monitoring Private Sector 21194 1695520 0

312.54(a)(b) Submissions concerning exception from informed consent under 50.24 No Health Public Health Monitoring Private Sector 1 48 0

312.55(b) Sponsor reports on new observations, e.g. adverse reactions and safe use No Health Public Health Monitoring Private Sector 2271300 109022400 0

312.56(b)(c)(d) Sponsor monitoring of investigations;notifications to FDA No Health Public Health Monitoring Private Sector 18 1440 0

312.58(a) Submission of records to FDA No Health Public Health Monitoring Private Sector 373 2984 0

312.64 Investigator reports to the sponsor No Health Public Health Monitoring Private Sector 31791 762984 0

312.70(a) Investigator disqualification; opportunity to respond No Health Public Health Monitoring Private Sector 4 160 0

312.110(b) Request to export and investigational drug No Health Public Health Monitoring Private Sector 420 31500 0

312.120 Submissions related to foreign clinical studies not conducted under an IND No Health Public Health Monitoring Private Sector 575 18400 0

312.130(d) Request for disclosable information for investigations involving an exception from informed consent No Health Public Health Monitoring Private Sector 3 24 0

312.52(a) Transfer of obligations to a contract research organization No Health Public Health Monitoring Private Sector 503 1006 0

312.57 Sponsor recordkeeping No Health Public Health Monitoring Private Sector 36396 3639600 0

312.62(a) Investigator recordkeeping of disposition of drugs No Health Public Health Monitoring Private Sector 14732 589280 0

312.62(b) Investigator recordkeeping of case histories of individuals No Health Public Health Monitoring Private Sector 147320 5892800 0

312.60(a)(3)Records of shipment of drugs for investigational use in laboratory research animals or in vitro tests No Health Public Health Monitoring Private Sector 782 391 0

312.160(c) Shipper records of alternative disposition of unused drugs No Health Public Health Monitoring Private Sector 782 391 0

312.8 Biologics; Charging for investigational drugs under an IND No Health Public Health Monitoring Private Sector 57 1368 0

312.23 and 312.120(b)(c)(2)(c)(3). Biologics; Investigational New Drug Submission No Health Public Health Monitoring Private Sector 563 1017904 0

312.30(a)-(e) Biologics; Protocol Amendments No Health Public Health Monitoring Private Sector 4012 1139408 0

312.31(b) Biologics; Information amendments No Health Public Health Monitoring Private Sector 7706 770600 0

312.32(c)(d) and 312.56(c) Biologics; Safety Reports and Notifications No Health Public Health Monitoring Private Sector 4028 128896 0

312.33(a) -(f) and 312.56(c) Biologics; Annual reports and related notifications No Health Public Health Monitoring Private Sector 1488 535680 0

Investigational New Drug Regulations No Health Public Health Monitoring Private Sector 0 0 0

Investigational New Drug Regulations No Health Public Health Monitoring Private Sector 0 0 0

312.38(b)(c) Biologics; Notification of withdrawal of an IND No Health Public Health Monitoring Private Sector 152 4256 0

312.42(e) Biologics; Request to remove clinical hold No Health Public Health Monitoring Private Sector 111 31524 0

312.44(c) and (d) Biologics; Response to termination of IND No Health Public Health Monitoring Private Sector 18 304 0

312.45(a) and (b) Biologics; Request for or response to inactive status determination No Health Public Health Monitoring Private Sector 108 1296 0

312.47(b) Biologics; End-of-Phas 2 and Pre-NDA meetings No Health Public Health Monitoring Private Sector 65 10400 0

312.53(c) Biologics; Investigator Information No Health Public Health Monitoring Private Sector 2297 183760 0

312.54(a) and (b) Biologics; Submissions concerning exception from informed consent under 50.24 No Health Public Health Monitoring Private Sector 1 48 0

312.55(b) Biologics; Sponsor reports on new observations; e.g. adverse reactions and safe use No Health Public Health Monitoring Private Sector 345 16560 0

312.56(b) and (d) Biologics; Sponsor monitoring of clinical investigations; notification to FDA No Health Public Health Monitoring Private Sector 22 1760 0

312.58(a) Biologics; Sponsor submission of records No Health Public Health Monitoring Private Sector 8 64 0

312.64 Investigator Reports to the sponsor No Health Public Health Monitoring Private Sector 21010 504240 0

312.70(a) Biologics; Investigator disqualification - opportunity to respond No Health Public Health Monitoring Private Sector 6 240 0

312.110(b) Request to export an investigational drug No Health Public Health Monitoring Private Sector 21 1575 0

312.130(d) Biologics; Request for disclosable information for investigations involving an exception from informed consent No Health Public Health Monitoring Private Sector 1 8 0

312.52(a) Biologics; Transfer of obligations to a contract research organization No Health Public Health Monitoring Private Sector 195 390 0

312.57(a)(b) Biologics; Sponsor recordkeeping No Health Public Health Monitoring Private Sector 1126 112600 0

312.62(a) Biologics; Investigator recordkeeping of disposition of drugs No Health Public Health Monitoring Private Sector 5570 222800 0

312.62(b) Biologics; Investigator recordkeeping of case histories of individuals No Health Public Health Monitoring Private Sector 55700 2228000 0

312.160(a)(3) Biologics; Records maintenance: shipment of drugs for investigational use in laboratory research animals or in vitro tests No Health Public Health Monitoring Private Sector 204 102 0

312.160(c) Biologics; Shipper records of alternative disposition of unused drugs No Health Public Health Monitoring Private Sector 204 102 0

312.310(d) Emergency use of an investigational new drug No Health Public Health Monitoring Private Sector 646 10336 0

312.315(c) and 312.305 (b) Submissions related to expanded access and treatment of an individual patient. No Health Public Health Monitoring Private Sector 68 8160 0

312.320 Submissions related to treatment IND or treatment protocol No Health Public Health Monitoring Private Sector 10 3000 0

2012-04-16-04:00

0910-0016 201104-0910-003 0910
             
        "Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; and Electronic Submission Using FDA Forms 3503 and 3504"
             
          
        
Currently, interested persons may transmit regulatory submissions to the Office of Food Additivie Safety in the Center for Food Safety and Applied Nutrition using Form FDA 3504 for color additive petitions. FDA is revising Form FDA 3503 to better enable its use for electronic submission and to permit its use for multiple types of submissions, which eliminates the need for Form FDA 3504. This action is a consolidation of Form FDA 3504 under Form FDA 3503, which after OMB approval for this request Form FDA 3504 will be discontinued. In summary, the revised Form FDA 3503 will be used for food additive and color additive petitions. 2014-06-30-04:00 Active Denver Presley 3018271462 No No No 12 26573 5600

Submission of Petitions, Color Additive Including Labeling No Health Consumer Health and Safety
3503 Food Additive; Color Additive Petition; Food Master File; Color Master File Yes Yes Fillable Printable Form Revised Draft Form FDA 3503 for 2010.pdf Yes No Printable Only Other Instructions - Revised Draft Form FDA 3503.pdf
Private Sector 2 2674 5600

Submission of Petitions Generally Recognized As Safe Affirmation No Health Consumer Health and Safety
3503 Food additive Petition; Color Additive Petition;; Food Master File; Color Master File Yes Yes Fillable Printable Form Revised Draft Form FDA 3503 for 2010.pdf Yes Yes Printable Only Instruction Instructions - Revised Draft Form FDA 3503.pdf
Private Sector 1 2614 0

Submission of Petitions: Food Additive Including Labeling No Health Consumer Health and Safety
3503 Food additive Petition; Color Additive Petition; Food Master File; Color Master file Yes Yes Fillable Printable Form Revised Draft Form FDA 3503 for 2010.pdf Yes Yes Printable Only Instruction Instructions - Revised Draft Form FDA 3503.pdf
Private Sector 3 21279 0

Form FDA 3503 No Health Consumer Health and Safety
3503 Food Additive Petition; Color Additive Petition; Food Master File; Color Master File Yes Yes Fillable Printable Form Revised Draft Form FDA 3503 for 2010.pdf Yes Yes Printable Only Instruction Instructions - Revised Draft Form FDA 3503.pdf
Private Sector 6 6 0

2011-06-27-04:00

0910-0021 201303-0910-004 0910
             
        "Interstate Shellfish Dealer's Certificate"
             
          
        
The information collected is used to compile, publish, and distribute a listing of approved sources of state and international certified shellfish dealers/shippers. Food control officials and the food industry use the list to determine certified sources of shellfish. 2016-05-31-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 2280 228 0

Interstate Shellfish Dealer's Certificate No Health Consumer Health and Safety
FDA Form 3038 Interstate Shellfish Dealer's Certificate Yes Yes Fillable Fileable Form FDA Form3038 Shellfish-proposed.pdf
State, Local, and Tribal Governments 2280 228 0

2013-05-23-04:00

0910-0025 201311-0910-008 0910
             
        "Reporting and Recordkeeping for Electronic Products - General Requirements"
             
          
        
To protect the public from unnecessary exposure to radiation from electronic products, FDA must collect certain information from manufacturers and dealers/distributors about electronic products they sell or install. This ICR collects information from electronic product and x-ray manufacturers, importers, and assemblers. These respondents report and maintain information related to the identification of, location of, operational characteristics of, quality assurance programs for, and problem identification and correction of electronic products. The data reported to the Food and Drug Administration (FDA) and the records maintained are used by FDA and industry to make decisions and take actions that protect the public from radiation hazards presented by electronic products. The information collections are either specifically called for in legislation or were developed to aid FDA in performing its obligations under legislation. 2017-01-31-05:00 Active JonnaLynn Capezzuto jonnalynn.capezzuto@fda.hhs.gov 301 827-4659 No No No 2846697 516974 0

Reporting for Electronic Products: General Requirements No Health Consumer Health and Safety
FDA 3628 General Med X-ray annual report (esubmitter) Yes Yes Fillable Fileable Form and instruction 3628 esubmitter Med X-Ray Annual Blank Form.pdf FDA 3663 Microwave products (non-oven) (esubmitter) Yes Yes Fillable Fileable Form and instruction 3663 esubmitter Abbrev Microwave Blank.pdf FDA 3662 Cephalometric device (esubmitter) Yes Yes Fillable Fileable Form and instruction 3662 esubmitter Cephalometric Blank form.pdf FDA 3661 X-ray tables, etc (esubmitter) Yes Yes Fillable Fileable Form and instruction 3661 esubmitter Abbrev X-Ray Blank form.pdf FDA 3629 General abbreviated report (esubmitter) Yes Yes Fillable Fileable Form and instruction 3629 esubmitter Abbreviated Blank Form.pdf FDA 3801 UV lamps (esubmitter) Yes Yes Fillable Fileable Form and instruction 3801 esubmitter Medical UV Lamps Blank.pdf FDA 3660 Microwave oven (esubmitter) Yes Yes Fillable Fileable Form and instruction 3660 esubmitter MWO Blank form.pdf FDA 3626 Diagnostic X-Ray Yes Yes Fillable Fileable Form and instruction 3626 pdf D X-Ray BlankForm.pdf FDA 3659 TV (esubmitter) Yes Yes Fillable Fileable Form and instruction 3659 esubmitter TV Blank form.pdf FDA 3644 Ultrasonic therapy (esubmitter) Yes Yes Fillable Fileable Form and instruction 3644 esubmitter Therapy Ultrasound Blank.pdf FDAS 3646 Mercury vapor lamp (esubmitter) Yes Yes Fillable Fileable Form and instruction 3646 esubmitter Mercury Vapor Blank form.pdf FDA 3630 Sunlamp (esubmitter) Yes Yes Fillable Fileable Form and instruction 3630 esubmitter Sunlamp Blank form.pdf FDA 3630 Sunlamp Yes Yes Fillable Fileable Form and instruction 3630 pdf Sunlamp Blank form.pdf FDA 3640 Laser Light Show (esubmitter) Yes Yes Fillable Fileable Form and instruction 3640 esubmitter LLS Show Blank form.pdf FDA 3640 Laser Light Show Yes Yes Fillable Fileable Form and instruction 3640 pdf LLS Show Blank form.pdf FDA 3632 Laser (esubmitter) Yes Yes Fillable Fileable Form and instruction 3632 esubmitter Laser Blank form.pdf FDA 3632 Laser Yes Yes Fillable Fileable Form and instruction 3632 pdf Laser Blank form.pdf FDA 3639 Cabinet X-Ray (esubmitter) Yes Yes Fillable Fileable Form and instruction 3639 esubmitter Cab X-Ray blank form.pdf FDA 3627 CT X-Ray (esubmitter) Yes Yes Fillable Fileable Form and instruction 3627 esubmitter DX CT Blank form.pdf FDA 3627 CT X-Ray Yes Yes Fillable Fileable Form and instruction 3627 pdf DX CT Blank form.pdf FDA 3626 Diagnostic X-Ray (esubmitter) Yes Yes Fillable Fileable Form and instruction 3626 esubmitter D X-Ray BlankForm.pdf FDA 3638 Diagnostic X-ray annual report (esubmitter) Yes Yes Fillable Fileable Form and instruction 3638 esubmitter X-Ray Annual.pdf FDA 3634 TV annual report (esubmitter) Yes Yes Fillable Fileable Form and instruction 3634 esubmitter TV Annual Blank Form.pdf FDA 3641 Cabinet x-ray annual report (esubmitter) Yes Yes Fillable Fileable Form and instruction 3641 esubmitter Cab X-Ray Blank Form.pdf FDA 3643 MIcrowave oven annual report Yes Yes Fillable Fileable Form and instruction 3643 esubmitter MWO Annual Blank Form.pdf FDA 3636 Laser annual report (esubmitter) Yes Yes Fillable Fileable Form and instruction 3636 esubmitter Laser Annual Blank Form.pdf FDA 3631 Sunlamp annual report (esubmitter) Yes Yes Fillable Fileable Form and instruction 3631 esubmitter Sunlamp Annual Blank Form.pdf
Private Sector 53392 81460 0

Recordkeeping for Electronic Products: General Requirements No Health Consumer Health and Safety Private Sector 2790100 324375 0

Third party disclosure for Electronic Products: General Requirements No Health Consumer Health and Safety Private Sector 3205 111139 0

2014-01-03-05:00

0910-0027 201102-0910-012 0910
             
        "Voluntary Cosmetic Registration Program"
             
          
        
The "Voluntary Cosmetic Registration Program" provides FDA with the best information available about the locations, business trade names, and types of activity (manufacturing and packaging) of establishment that participate in this program. FDA uses the registration to estimate the size of the cosmetic industry and for conducting on site establishment inspections. 2014-04-30-04:00 Active Denver Presley 3018271462 No No No 7525 1827 0

Reporting - 21 CFR Part 710 - Voluntary Registration of Cosmetics Product Establishment No Health Consumer Health and Safety
FDA 2511 Registration of Cosmetic Product Establishment http://www.cfsan.fda.gov/~dms/cos-reg2.html Yes Yes Fillable Printable Form and instruction 0027 FDA Form 2511.doc
Private Sector 135 27 0

Reporting - 21 CFR- 720.1 - 720.4 - Voluntary Registration ( New submissions No Health Consumer Health and Safety
2512 a Cosmetic Product Ingredient Yes Yes Fillable Printable Form and instruction Form FDA 2512a.pdf 2512 Cosmetic Product Ingredient Statement Yes Yes Fillable Printable Form and instruction Form FDA 2512.pdf
Private Sector 4371 1442 0

Reporting 21 CFR 720.6 Voluntary Registration ( Amendments) No Health Consumer Health and Safety
2512a Cosmetic Product Ingredient Yes Yes Fillable Printable Form and instruction Form FDA 2512a.pdf 2512 Cosmetic Product Ingredient statement Yes Yes Fillable Printable Form and instruction Form FDA 2512.pdf
Private Sector 763 130 0

Reporting 21CFR 720.6 Voluntary Registration ( Notices of Discontinuance) No Health Consumer Health and Safety
2514 Notice of Discontinuance of Commercial Distribution of Cosmetic Product Formulation Yes Yes Fillable Printable Form and instruction Form FDA 2514.pdf
Private Sector 2255 226 0

Reporting 21 CFR 720.8 Voluntary Registration ( Request for Confidentiality) No Health Consumer Health and Safety Private Sector 1 2 0

2011-04-29-04:00

0910-0032 201305-0910-003 0910
             
        "New Animal Drug Application, 21 CFR Part 514"
             
          
        
Certain information that submitted as part of a New Animal Drug Application (NADA) must include safety and effectiveness data, proposed labeling, product manufacturing information, and where necessary, complete information on food safety (including microbial food safety) and any methods used to determine residues of new animal drugs in edible tissues from food producing animals. 2016-07-31-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 1367 28218 0

Requesting presubmission conferences No Health Consumer Health and Safety Private Sector 69 3450 0

Applications and amended applications No Health Consumer Health and Safety Private Sector 12 2544 0

Manufacturing changes to an approved application No Health Consumer Health and Safety Private Sector 375 13125 0

Labeling and other changes to an approved application No Health Consumer Health and Safety Private Sector 10 710 0

Labeling and other changes to an approved application No Health Consumer Health and Safety Private Sector 121 2420 0

Submission of data, studies, and other information No Health Consumer Health and Safety Private Sector 14 14 0

Requirements for liquid medicated feed No Health Consumer Health and Safety Private Sector 2 10 0

Evidence to establish safety and effectiveness No Health Consumer Health and Safety Private Sector 25 2250 0

Form FDA 356V No Health Consumer Health and Safety
FDA 356V Application for Approval of a New Animal Drug (Or Submission to Support New Animal Drug Approval) Yes Yes Fillable Fileable Form and instruction 0032 FDA356V 5-1-13 ICR.pdf
Private Sector 739 3695 0

2013-07-02-04:00

0910-0037 201106-0910-005 0910
             
        "Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified and Thermally Processed Low-Acid Foods"
             
          
        
The information is necessary to ensure safe manufacturing, processing, and packing procedures and to permit FDA to verify that these procedures are being followed. 2015-02-28-05:00 Active Denver Presley 3018271462 No No No 86878 2380467 0

Reporting: Food Canning Establishment Registration for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers - Form FDA 2541 No Health Consumer Health and Safety
FDA-2541 FDA-2541 Yes No Fillable Printable Form and instruction FDA-2541.pdf 1 Register Food Canning Establishment Yes No Fillable Printable Form and instruction Register Food Canning Establishment.pdf
Private Sector 515 88 0

Reporting: - Food Canning Establishment, Process Filing for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers - Form FDA 2541 a No Health Consumer Health and Safety
2541a Process Filing For All Methods Except Low - Acid Aseptic Yes Yes Fillable Printable Form and instruction Form FDA 2541a Process Filing.pdf
Private Sector 12835 4274 0

Reporting: Food Canning Establishment , Food Process Filing for Low Acid Aseptic Systems - Form FDA 2541c No Health Consumer Health and Safety
2541c Food Processing for Low Acid Aseptic Yes Yes Fillable Printable Form and instruction Form FDA 2541 c ( aseptic systems).pdf
Private Sector 653 490 0

Recordkeeping: 21 CFR 113 and 114 - Food Canning Establishment Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers No Health Consumer Health and Safety Private Sector 9500 2375000 0

Recordkeeping: 21 CFR 113.100 ( C ) and ( d ) - Food Canning Establishment Temperature Indicating Devices : Thermally Processed Low - Acid Foods Packaged in Hermetically Sealed Containers No Health Consumer Health and Safety Private Sector 63375 615 0

2012-02-27-05:00

0910-0045 201203-0910-007 0910
             
        "Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution"
             
          
        
21 CFR part 207 implements section 510 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360), under which FDA is authorized to establish a system for registration of producers of drugs and for listing of drugs in commercial distribution. 2015-08-31-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 45168 227222 0

June and December updates of all drug listing information No Health Consumer Health and Safety
FDA Form 2658 Registered Establishment No No Paper Only Form FDA-2658.pdf No No Paper Only Other Reg and list final guid 12-5-08 to OMB.doc FDA Form 2657 Drug Product Listing (New Drug Listing) No No Paper Only Form FDA-2657.pdf No No Paper Only Instruction form2656.htm No No Paper Only Instruction 2658instruc..htm FDA Form 2656 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) No No Paper Only Form FDA-2656.doc
Private Sector 18799 84596 0

New registrations, including new labeler codes requests No Health Consumer Health and Safety
FDA Form 2656 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) No No Paper Only Form FDA-2656.doc FDA Form 2658 Registered Establishment No No Paper Only Form FDA-2658.pdf No No Paper Only Other Reg and list final guid 12-5-08 to OMB.doc FDA Form 2657 Drug Product Listing (New Drug Listing) No No Paper Only Form FDA-2657.pdf No No Paper Only Instruction form2656.htm No No Paper Only Instruction 2658instruc..htm
Private Sector 574 2583 0

Annual updates of registration information No Health Consumer Health and Safety
FDA Form 2656 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) No No Paper Only Form FDA-2656.doc FDA Form 2658 Registered Establishment No No Paper Only Form FDA-2658.pdf No No Paper Only Instruction 2658instruc..htm No No Paper Only Instruction form2656.htm FDA Form 2657 Drug Product Listing (New Drug Listing) No No Paper Only Form FDA-2657.pdf No No Paper Only Other Reg and list final guid 12-5-08 to OMB.doc
Private Sector 9735 43808 0

New drug listings No Health Consumer Health and Safety
FDA Form 2657 Drug Product Listing (New Drug Listing) No No Paper Only Form FDA-2657.pdf No No Paper Only Instruction 2658instruc..htm No No Paper Only Other Reg and list final guid 12-5-08 to OMB.doc FDA Form 2658 Registered Establishment No No Paper Only Form FDA-2658.pdf FDA Form 2656 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) No No Paper Only Form FDA-2656.doc No No Paper Only Instruction form2656.htm
Private Sector 10295 46328 0

New listings for private label distributor No Health Consumer Health and Safety
No No Paper Only Other Reg and list final guid 12-5-08 to OMB.doc FDA Form 2658 Registered Establishment No No Paper Only Form FDA-2658.pdf No No Paper Only Instruction form2656.htm No No Paper Only Instruction 2658instruc..htm FDA Form 2656 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) No No Paper Only Form FDA-2656.doc FDA Form 2657 Drug Product Listing (New Drug Listing) No No Paper Only Form FDA-2657.pdf
Private Sector 1469 6611 0

Waiver requests No Health Consumer Health and Safety
FDA Form 2656 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) No No Paper Only Form FDA-2656.doc FDA Form 2658 Registered Establishment No No Paper Only Form FDA-2658.pdf No No Paper Only Instruction 2658instruc..htm FDA Form 2657 Drug Product Listing (New Drug Listing) No No Paper Only Form FDA-2657.pdf No No Paper Only Other Reg and list final guid 12-5-08 to OMB.doc No No Paper Only Instruction form2656.htm
Private Sector 1 1 0

Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution No Health Consumer Health and Safety
FDA Form 2656 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) No No Paper Only Form FDA-2656.doc FDA Form 2658 Registered Establishment No No Paper Only Form FDA-2658.pdf No No Paper Only Instruction 2658instruc..htm No No Paper Only Instruction form2656.htm FDA Form 2657 Drug Product Listing (New Drug Listing) No No Paper Only Form FDA-2657.pdf No No Paper Only Other Reg and list final guid 12-5-08 to OMB.doc
Private Sector 1000 40000 0

SOP maintenance No Health Consumer Health and Safety
No No Paper Only Instruction 2658instruc..htm FDA Form 2658 Registered Establishment No No Paper Only Form FDA-2658.pdf FDA Form 2656 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) No No Paper Only Form FDA-2656.doc FDA Form 2657 Drug Product Listing (New Drug Listing) No No Paper Only Form FDA-2657.pdf No No Paper Only Other Reg and list final guid 12-5-08 to OMB.doc No No Paper Only Instruction form2656.htm
Private Sector 3295 3295 0

2012-08-15-04:00

0910-0046 201102-0910-009 0910
             
        "Electronic Importer's Entry Notice"
             
          
        
On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) (Public Law 111-31) into law. The Tobacco Control Act amended the Federal, Food, Drug, and Cosmetic Act (FD&C Act) by adding a new chapter granting the Food and Drug Administration (FDA) important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. With the passage of the Tobacco Control Act, section 801 of the FD&C Act was amended to add tobacco products to the inventory of FDA-regulated products. The new section 801 charges the Secretary of Health and Human Services (HHS), through the FDA, with the responsibility of assuring foreign origin FDA regulated foods, drugs, cosmetics, medical devices, radiological health, and tobacco products offered for import into the United States meet the same requirements of the act as do domestic products, and for preventing products from entering the country if they are not in compliance. The discharge of this responsibility involves close coordination and cooperation between FDA headquarters and field inspectional personnel and the U.S. Customs Service (USCS), as the USCS is responsible for enforcing the revenue laws covering the very same products. 2014-04-30-04:00 Active Jonnalynn Capezzuto 3018274659 No No No 3722734 521179 0

Electronic Importer's Entry Notice No Health Public Health Monitoring Private Sector 3722734 521179 0

2011-04-25-04:00

0910-0052 201201-0910-002 0910
             
        "Blood Establishment Registration and Product Lising Form FDA 2830"
             
          
        
Under section 510 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360), any person owning or operating an establishment that manufactures, prepares, propagates, compounds, or processes a drug or device must register with the Secretary of Health and Human Services, on or before December 31 of each year, his or her name, place of business, and all such establishments must submit, among other information, a listing of all drug or device products manufactured, prepared, propagated, compounded, or processed by him or her for commercial distribution. The regulations of establishment registration and product listing for blood establishments are found in 21 CFR Part 607. These establishments are required to submit this information on Form FDA 2830. 2015-03-31-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 2818 1389 0

Initial Registration No Health Consumer Health and Safety
2830 Blood Establishment Registration and Product Listing Yes Yes Printable Only Form and instruction FDA-2830 12-2008.doc
Private Sector 49 49 0

Re-registration No Health Consumer Health and Safety
2830 Blood Establishment Registration and Product Listing Yes Yes Printable Only Form and instruction FDA-2830 12-2008.doc
Private Sector 2589 1295 0

Product Listing Update No Health Consumer Health and Safety
2830 Blood Establishment Registration and Product Listing Yes Yes Printable Only Form and instruction FDA-2830 12-2008.doc
Private Sector 180 45 0

2012-03-08-05:00

0910-0053 201103-0910-012 0910
             
        "Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary"
             
          
        
The information is needed for the collection requirements contained in 21 CFR 361.1. The information will be reviewed to determine the qualifications of the membership and the appropriateness of approved studies. The respondents are the Chairpersons, investigators, and members of the approved Radioactive Drug Research Committees. 2014-05-31-04:00 Active Eliazabeth Berbakos 3018271482 No No No 1420 4759 0

Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary No Health Illness Prevention
FDA 2914 Membership Summary No No Paper Only Form FDA-2914.doc
Private Sector 80 80 0

Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary No Health Illness Prevention
FDA 2915 Study Summary No No Paper Only Form FDA-2915.doc
Private Sector 340 1190 0

Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary No Health Illness Prevention Private Sector 340 34 0

Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary No Health Illness Prevention
FDA 2915 Study Summary No No Paper Only Form FDA-2915.doc
Private Sector 320 3200 0

Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary No Health Illness Prevention
FDA 2915 Study Summary No No Paper Only Form FDA-2915.doc
Private Sector 340 255 0

2011-05-20-04:00

0910-0073 201312-0910-006 0910
             
        "Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation"
             
          
        
This ICR collects information from medical device manufacturers who must meet the Current Good Manufacturing Practice Quality System (CGMP/QS) requirements for purchasing and service controls; recordkeeping requirements for device failure and complaint investigations; requirements for verifying/validating production processes and process or product changes; and requirements for product acceptance activities, quality data evaluations, and corrections of nonconforming product/quality problems. CGMP/QS information collections assist FDA inspections of manufacturer compliance with quality system requirements encompassing design, production, installation, and servicing processes. Manufacturers must ensure that medical devices meet design specifications and that design specifications are effectively transferred from research and development to production. 2017-02-28-05:00 Active JonnaLynn Capezzuto jonnalynn.capezzuto@fda.hhs.gov 301 827-4659 No No No 25986 9043128 0

Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation No Health Consumer Health and Safety Private Sector 25986 9043128 0

2014-02-07-05:00

0910-0078 201301-0910-001 0910
             
        "Investigational Device Exemptions Reports and Records - 21 CFR 812"
             
          
        
The Food and Drug Administration (FDA) is requesting approval from the Office of Management and Budget (OMB) for information collection requirements contained in 21 CFR, Part 812. The IDE regulation permits a device to be shipped in interstate commerce for clinical investigation to determine its medical safety and effectiveness. Although the IDE regulations exempts the device from certain requirements of the Act, it requires safeguards for humans who are subjects of investigations; maintenance of sound ethical standards; and procedures to assure development of reliable scientific data. 2016-03-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 9493 64227 0

Reporting No Health Immunization Management Private Sector 4631 54253 0

Recordkeeping No Health Immunization Management Private Sector 4861 9968 0

Third Party Disclosures No Health Immunization Management Private Sector 1 6 0

2013-03-20-04:00

0910-0114 201302-0910-002 0910
             
        "Administrative Detention and Banned Medical Devices"
             
          
        
The FDA has the statutory authority under section 304(g) of the FD&C Act to detain devices during establishment inspections which are believed to be adulturated or misbranded. On March 9, 1979, FDA issued a final regulation on Administrative Detention Procedures which includes, among other things, certain reporting and recordkeeping requirements. FDA also has the statutory authority under section 516 of the Act to ban devices that present substantial deception, unreasonable and substantial risk of illness or injury, or unreasonable, direct and substantial danger to the health of individuals. Under these authorities there are requirements pertaining to reporting and recordkeeping activities that are necessary in order for the Agency to carry out its mission to protect the public health. 2016-04-30-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 28 461 0

Administrative Detention and Banned Medical Devices No Health Consumer Health and Safety Private Sector 28 461 0

2013-04-10-04:00

0910-0116 201201-0910-001 0910
             
        "Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components"
             
          
        
The information collection requirements in the CGMP, donor testing, donor notification, and "lookback" regulations provide FDA with the necessary information to perform its duty to ensure the safety, purity, and potency of blood and blood components. These requirements establish accountability and traceability in the processing and handling of blood and blood components and enable FDA to perform meaningful inspections. The recordkeeping requirements serve preventative and remedial purposes. The disclosure requirements identify the various blood and blood components and important properties of the product, demonstrate that the CGMP requirements have been met, and facilitate the tracing back of a product to its original source. The reporting requirements inform FDA of any deviations that occur and that may require immediate corrective action. 2015-04-30-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 3206393 506637 0

Reporting burden: adverse reactions and testing No Health Consumer Health and Safety Private Sector 78 1522 0

Recordkeeping burden: SOPs and maintenance of records No Health Consumer Health and Safety Private Sector 2672173 443786 0

Third party disclosure: adverse reactions, test requirements, labeling, "lookback" requirements, donor notification No Health Consumer Health and Safety Private Sector 534142 61329 0

2012-04-09-04:00

0910-0117 201207-0910-001 0910
             
        "New Animal Drugs for Investigational Use"
             
          
        
To gain approval to market an animal drug, the applicant must file a New Animal Drug Application containing data to support the safety and effectiveness of the drug, appropriate labeling, product manufacturing information and where applicable, methods to determine residues of the drug in edible tissue from food producing animals. 2015-10-31-04:00 Active Denver Presley 3018271462 No No No 5528 12328 0

511.1(b)(4) NCIE for clinical investigations No Health Consumer Health and Safety
3458 Notice of Claimed Investigational Exemption Yes Yes Fillable Printable Form and instruction FDA Form 3458.pdf
Private Sector 1238 1238 0

511.1(b)(5) Data submission for use of edible food products No Health Consumer Health and Safety Private Sector 70 560 0

511.1(b)(6) Information required in order to determine if there are grounds for terminating exemption No Health Consumer Health and Safety Private Sector 2 2 0

511.1(b)(8) (ii) Report of significant hazards No Health Consumer Health and Safety Private Sector 15 30 0

511.1(b)(9) Import for clinical investigation No Health Consumer Health and Safety Private Sector 15 120 0

511.1(a)(3) - Recordkeeping for laboratory research No Health Consumer Health and Safety Private Sector 474 474 0

511.1(b)(3) - Recordkeeping for clinical investigations No Health Consumer Health and Safety Private Sector 1238 1238 0

511.1(b)(7)(ii) - Recordkeeping sponsor No Health Consumer Health and Safety Private Sector 1238 4333 0

511.1(b)(8)(i) - Recordkeeping of investigator reports No Health Consumer Health and Safety Private Sector 1238 4333 0

2012-10-22-04:00

0910-0119 201107-0910-008 0910
             
        "Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies - 21 CFR Part 58"
             
          
        
The GLP regulations are intended to assure the quality and integrity of the safety data submitted to FDA in support of the approval of regulated products. The required information will help assure that only safe products are approved for marketing. 2014-09-30-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 36150 1311157 0

Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies - 21 CFR Part 58 No Health Public Health Monitoring Private Sector 36150 1311157 0

2011-09-05-04:00

0910-0120 201311-0910-009 0910
             
        "Premarket Notification Submission 510(k), Subpart E"
             
          
        
This ICR collects information from persons who intend to market a medical device. Based on the information provided in the premarket notification (510(k)) submission, FDA determines whether a new device provides reasonable assurance of the safety and effectiveness of the device through substantial equivalence to a legally marketed device and whether the device can, therefore, be allowed to enter the U.S. market. Because the review of 510(k) submissions confirms that the new device is as safe and as effective as legally marketed predicate devices, potentially unsafe and/or ineffective devices, including those with fraudulent claims, are prevented from entering the U.S. market. 2017-01-31-05:00 Active JonnaLynn Capezzuto jonnalynn.capezzuto@fda.hhs.gov 301 827-4659 No No No 9470 336051 0

Premarket Notification Submission 510(k), Subpart E No Health Consumer Health and Safety
FDA 3541 Premarket Notification [510(K)] Status Request and Response Yes Yes Fillable Fileable Form and instruction FDA 3541.pdf FDA 3514 CDRH Premarket Review Coversheet Yes Yes Fillable Fileable Form and instruction FDA 3514.pdf FDA 3654 Standards Data Report for 510(k)s Yes Yes Fillable Fileable Form and instruction FDA 3654.pdf
Private Sector 9470 336051 0

2014-01-03-05:00

0910-0130 201012-0910-005 0910
             
        "Protection of Human Subjects; Recordkeeping Requirements for Institutional Review Boards (IRBs)"
             
          
        
Section 56.115 specifies the types of records to be maintained by institutional review boards which could be subject to review by an investigator. 2014-04-30-04:00 Active Eliazabeth Berbakos 3018271482 No No No 36500 3650000 0

Protection of Human Subjects; Recordkeeping Requirements for Institutional Review Boards (IRBs) No Health Public Health Monitoring Private Sector 36500 3650000 0

2011-04-25-04:00

0910-0131 201307-0910-004 0910
             
        "Agreement for Shipments of Devices for Sterilization"
             
          
        
Nonsterile medical devices that are labeled as sterile but are in interstate transit to a facility to be sterilized are normally considered by the Food and Drug Administration (FDA) to be adulterated and misbranded. FDA regulations established a control mechanism by which firms may manufacture and label medical devices as "sterile" at one establishment and ship the devices in interstate commerce for actual sterilization at another establishment, a practice that facilitates the processing of devices and is economically necessary for some firms. Manufacturers and sterilizers may sign an agreement containing instructions for maintaining accountability of the number of units in each shipment, acknowledgment that the devices are nonsterile and are being shipped for further processing, and specifications for the product's sterilization processing. This agreement allows the manufacturer to ship adulterated or misbranded products to be sterilized without initiating regulatory action and provides FDA with a means to protect consumers from use of nonsterile products. The agreement must include: (a) Instructions for maintaining accountability of the number of units in each shipment; (b) acknowledgment that the devices are nonsterile, being shipped for further processing; and (c) specifications for sterilization processing. These agreements must be retained for two years, as FDA may review them up to two years after final shipment or delivery of devices. 2016-08-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 1800 8100 0

Agreement for Shipments of Devices for Sterilization No Health Consumer Health and Safety Private Sector 1800 8100 0

2013-08-16-04:00

0910-0133 201108-0910-008 0910
             
        "Temporary Marketing Permit Applications"
             
          
        
Section 401 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 341), directs FDA to issue regulations establishing definitions and standards of identity for food whenever * * * such action will promote honesty and fair dealing in the interest of consumers * * *." Under section 403(g) of the act (21 U.S.C. 343(g)), a food that is subject to a definition and standard of identity prescribed by regulation is misbranded if it does not conform to such definition and standard of identity. Section 130.17 (21 CFR 130.17) provides for the issuance by FDA of temporary marketing permits that enable the food industry to test consumer acceptance and measure the technological and commercial feasibility in interstate commerce of experimental packs of food that deviate from applicable definitions and standards of identity. Section 130.17(c) enables the agency to monitor the manufacture, labeling, and distribution of experimental packs of food that deviate from applicable definitions and standards of identity. The information so obtained can be used in support of a petition to establish or amend the applicable definition or standard of identity to provide for the variations. Section 130.17(i) specifies the information that a firm must submit to FDA to obtain an extension of a temporary marketing permit. 2014-09-30-04:00 Active Denver Presley 3018271462 No No No 28 654 0

Reporting-21-CFR 130.17 ( c ) - Format and Information for Temporary Marketing Permit Request No Health Consumer Health and Safety Private Sector 26 650 0

Reporting - 21 CFR 130.17 (i) - Format and Information for Temporary Marketing Permit Extension No Health Consumer Health and Safety Private Sector 2 4 0

2011-09-27-04:00

0910-0138 201207-0910-010 0910
             
        "Reclassification Petitions for Medical Devices"
             
          
        
This colection requires device manufacturers to provide, in a petition for device reclassification, specification of the type of device, a statement of the action requested, and a justification for the request to reclassify. The classification regulation, 21 CFR Part 860 including subpart C, reclassification, was promulgated under the authority of 21 U.S.C. 360(e) and (f), 360d(b), 360e(b), 360j(1), and 360i(b)(1)(A). The staff of the Center for Devices and Radiological Health (CDRH) is responsible for reviewing petitions for reclassification and determining whether the subject device will be reclassified. In some instances, FDA also submits such petitions to one of its medical device advisory panels for review and recommendations. FDA's decision regarding the reclassification of a device is based primarily upon the information contained in the petition. 2015-06-30-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 6 3000 0

Reclassification Petitions for Medical Devices No Health Consumer Health and Safety
3429 FDA Form 3429 Yes Yes Fillable Printable Form and instruction Form FDA 3429 7-24-12.doc 3427 FDA Form 3427 Yes Yes Fillable Printable Form and instruction Form FDA 3427 Final.pdf
Private Sector 6 3000 0

2012-07-31-04:00

0910-0139 201109-0910-005 0910
             
        "Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals"
             
          
        
The CGMP regulations help ensure that drug products meet the statutory requirements for safety and have their purported or represented identity, strength, quality, and purity characteristics. The information collection requirements in the CGMP regulations are necessary to establish accountability in the manufacturing and processing of drug products, provide for meaningful FDA inspections, and enable manufacturers to improve the quality of drug products over time. The CGBP recordkeeping requirements also serve as crucial information if it is necessary to recall a drug product. 2015-04-30-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 1248727 848625 0

Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals No Health Public Health Monitoring Private Sector 1248727 848625 0

2012-04-09-04:00

0910-0152 201104-0910-010 0910
             
        "Current Good Manufacturing Practice Regulations for Medicated Feed, 21 CFR Part 225"
             
          
        
These recordkeeping requirements apply to medicated feeds produced by licensed and non-licensed feed manufacturers, both commercial feed mills and mixer-feeders. This information is needed so that FDA can monitor drug usage and possible mis-formulation of medicated feeds to investigate violative drug residues in products from treated animals and to investigate product defects when a drug is recalled. 2014-06-30-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 33893440 7138800 0

Current Good Manufacturing Practice Regulations for Medicated Feed, 21 CFR Part 225 No Health Consumer Health and Safety Private Sector 33893440 7138800 0

2011-06-27-04:00

0910-0154 201104-0910-012 0910
             
        "Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR Part 226"
             
          
        
A "Type A" medicated article is a feed product containing a concentrated drug, diluted with a feed carrier substance. Medicated feeds are administered to animals for prevention, mitigation, or treatment of disease or for growth promotion and feed efficiency. 2014-06-30-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 150650 157550 0

226.42 - Recordkeeping No Health Consumer Health and Safety Private Sector 29900 22425 0

226.58 - Recordkeeping No Health Consumer Health and Safety Private Sector 29900 52325 0

226.80 - Recordkeeping No Health Consumer Health and Safety Private Sector 29900 22425 0

226.102 - Recordkeeping No Health Consumer Health and Safety Private Sector 29900 52325 0

226.110 - Recordkeeping No Health Consumer Health and Safety Private Sector 29900 7475 0

226.115 - Recordkeeping No Health Consumer Health and Safety Private Sector 1150 575 0

2011-06-27-04:00

0910-0167 201106-0910-010 0910
             
        "Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)"
             
          
        
This information is required in the implementation and administration of the Orphan Drug Act, 21 U.S.C., Sections 526-528. The information is necessary to show that applicants qualify and continue to qualify for the incentives and assistance provided by the statute and regulations. 2014-10-31-04:00 Active Jonnalynn Capezzuto 3018274659 No No No 2183 69726 0

Written recommendations; content and format of a request, the providing of; refusal to provide No Health Immunization Management Private Sector 2 200 0

Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation No Health Immunization Management
FDA3671 Common EMEA/FDA Application for Orphan Medicinal Product Designation Yes Yes Fillable Fileable Signable Form and instruction FDA 3671.pdf
Private Sector 428 64200 0

Permanent resident agent for foreign sponsor No Health Immunization Management Private Sector 55 110 0

Changes in ownership of orphan drug designation No Health Immunization Management Private Sector 43 215 0

Annual reports of holder of orphan drug designation No Health Consumer Health and Safety Private Sector 1652 4956 0

Insufficient quantities of orphan drugs No Health Consumer Health and Safety Private Sector 3 45 0

Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671) No Health Consumer Health and Safety
FDA 3671 COMMON EMEA/FDA APPLICATION FORM FOR ORPHAN MEDICINAL PRODUCT DESIGNATION No No Paper Only Form and instruction Final version of Common EMEA-FDA Application Form for Orphan Medicinal Product designationFINAL FORM.doc
Private Sector 0 0 0

2011-10-31-04:00

0910-0183 201203-0910-006 0910
             
        "General Administrative Procedures:  Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions"
             
          
        
The Administrative Procedures Act (5 U.S.C. 553(e)) provides that every Agency shall give an interested person the right to petition for issuance, amendment, or repeal of a rule. Section 10.30 (21 CFR 10.30) sets forth the format and procedures by which an interested person may submit to FDA, in accordance with Sec. 10.20 (21 CFR 10.20) (submission of documents to Division of Dockets Management), a citizen petition requesting the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action. 2014-06-30-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 220 5122 0

Citizen Petition No Health Consumer Health and Safety Private Sector 207 4968 0

Administrative Reconsideration of Action No Health Consumer Health and Safety Private Sector 4 40 0

Administrative Stay of Action No Health Consumer Health and Safety Private Sector 5 50 0

Advisory Opinions No Health Consumer Health and Safety Private Sector 4 64 0

2012-06-11-04:00

0910-0184 201203-0910-010 0910
             
        "Filing Objections and Requests for a Hearing on a Regulation or Order"
             
          
        
The regulations in 21 CFR 12.22, issued under section 701(e)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(e)(2)), set forth the instructions for filing objections and requests for a hearing on a regulation or order under Sec. 12.20(d). Objections and requests must be submitted within the time specified in Sec. 12.20(e). Each objection, for which a hearing has been requested, must be separately numbered and specify the provision of the regulation or the proposed order. In addition, each objection must include a detailed description and analysis of the factual information and any other document, with some exceptions, supporting the objection. 2015-06-30-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 3 60 0

Filing Objections and Requests for a Hearing on a Regulation or Order No General Government Legislative Functions Individuals or Households 3 60 0

2012-06-11-04:00

0910-0186 201207-0910-013 0910
             
        "Irradiation in the Production, Processing and Handling of Food"
             
          
        
Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(s) and 348), food irradiation is subject to regulation under the food additive premarket approval provisions of the act. The regulations providing for uses of irradiation in the production, processing, and handling of food are found in part 179 (21 CFR part 179). To ensure safe use of a radiation source, ? 179.21(b)(1) requires that the label of sources bear appropriate and accurate information identifying the source of radiation and the maximum (or minimum and maximum) energy of radiation emitted by x-ray tube sources. Section 179.21(b)(2) requires that the label or accompanying labeling bear adequate directions for installation and use and a statement supplied by FDA that indicates maximum dose of radiation allowed. Section 179.26(c) requires that the label or accompanying labeling bear a logo and a radiation disclosure statement. Section 179.25(e) requires that food processors who treat food with radiation make and retain, for 1 year past the expected shelf life of the products up to a maximum of 3 years, specified records relating to the irradiation process (e.g., the food treated, lot identification, scheduled process, etc.) 2015-08-31-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 1020 1020 0

Irradiation in the Production, Processing and Handling of Food No Health Consumer Health and Safety Private Sector 900 900 0

Irradiation in the Production, Processing and Handling of Food No Health Consumer Health and Safety Private Sector 120 120 0

2012-08-31-04:00

0910-0188 201108-0910-013 0910
             
        "Infant Formula Recall Regulations"
             
          
        
Information required to conduct effective recalls of infant forumula. 2014-10-31-04:00 Active Denver Presley 3018271462 No No No 10 12854 0

Reporting: Requirements for Written Recall Strategy Furnished to Appropriate FDA District Office By Recalling Firm No Health Consumer Health and Safety Private Sector 2 8900 0

Reporting: Notification , Written Reports & Status Update Requirements for Recalling Firms or Establishments No Health Consumer Health and Safety Private Sector 2 2964 0

Reporting: Recommendation Requirements for Terminating a Recall by Recalling Firm No Health Consumer Health and Safety Private Sector 2 240 0

Reporting: Requirements For Additional Effectiveness Checks when Recall Implementation Is Determined Deficient No Health Consumer Health and Safety Private Sector 1 625 0

Third- Party Disclosure- Notification and Posting Requirements of Recall by Recalling Firm No Health Consumer Health and Safety Private Sector 2 100 0

Third- Party Disclosure- Additional Notification Requirements When Implementation of Recall Strategy is Determined Deficient No Health Consumer Health and Safety Private Sector 1 25 0

2011-10-23-04:00

0910-0191 201203-0910-008 0910
             
        "Notice of Participation"
             
          
        
Section 12.45 (21 CFR 12.45) issued under section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371), sets forth the format and procedures for any interested person to file a petition to participate in a formal evidentiary hearing, either personally or through a representative. Section 12.45 requires that any person filing a notice of participation state their specific interest in the proceedings, including the specific issues of fact about which the person desires to be heard. This section also requires that the notice include a statement that the person will present testimony at the hearing and will comply with specific requirements in 21 CFR 12.85, or, in the case of a hearing before a Public Board of Inquiry, concerning disclosure of data and information by participants (21 CFR 13.25). In accordance with sec. 12.45(e) the presiding officer may omit a participant's appearance. 2015-06-30-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 4 12 0

Notice of Participation No General Government Legislative Functions Private Sector 4 12 0

2012-06-11-04:00

0910-0206 201207-0910-005 0910
             
        "Request for Samples and Protocols"
             
          
        
FDA may at any time require manufacturers of licensed biological products to submit to FDA samples of any lot with the protocols showing the results of the applicable tests prior to distributing the lot of the product. Samples and protocols are required by FDA to help ensure the safety, purity and potency of the product because of thdue to the potential of lot-to-lot variability of a product produced from living organisms. 2015-11-30-05:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 6827 20572 0

Section 610.2 -- Requests for Samples and Protocols No Health Consumer Health and Safety Private Sector 6782 20346 0

Section 660.6(b) - Protocols No Health Consumer Health and Safety Private Sector 43 215 0

Section 660.36(a)(2) and (b) - Samples and Protocols No Health Consumer Health and Safety Private Sector 1 6 0

Section 660.46(b) - Request for Samples and Protocols No Health Consumer Health and Safety Private Sector 1 5 0

2012-11-26-05:00

0910-0212 201206-0910-010 0910
             
        "Regulations Under the Federal Import Milk Act "
             
          
        
The Federal Import Milk Act prohibits the imporation of milk and cream into the United States unless the shipper holds a valid Import Milk permit from the Food and Drug Administration. The act requires that all cows be healthy and that the dairy farm and processing plant be in good sanitary condition. 2015-08-31-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 410 609 0

Regulations Under the Federal Import Milk Act No Health Consumer Health and Safety
FDA1996 Dairy Farm Sanitation Report Yes Yes Paper Only Form and instruction 0212 FDA1996.pdf
Private Sector 400 600 0

Regulations Under the Federal Import Milk Act No Health Consumer Health and Safety
FDA1995 Physical examination of cows Yes Yes Paper Only Form and instruction 0212 FDA1995.pdf
Private Sector 1 1 0

Regulations Under the Federal Import Milk Act No Health Consumer Health and Safety
FDA1994 Tuberculin Test Yes Yes Paper Only Form and instruction 0212 FDA1994.pdf
Private Sector 1 1 0

Regulations Under the Federal Import Milk Act No Health Consumer Health and Safety
FDA1997 Sanitary inspections of plants Yes Yes Paper Only Form and instruction 0212 FDA1997.pdf
Private Sector 2 4 0

Regulations Under the Federal Import Milk Act No Health Consumer Health and Safety
FDA1993 Application for permit Yes Yes Paper Only Form and instruction 0212 FDA1993.pdf
Private Sector 2 1 0

Regulations Under the Federal Import Milk Act No Health Consumer Health and Safety
FDA1815 Permits granted on certificates Yes No Paper Only Form and instruction 0212 FDA1815.pdf
Private Sector 2 1 0

Regulations Under the Federal Import Milk Act No Health Consumer Health and Safety Private Sector 2 1 0

2012-08-31-04:00

0910-0216 201102-0910-011 0910
             
        "Color Additive Requests and Recordkeeping"
             
          
        
FDA has regulatory oversight for color additives used in foods, drugs, cosmetics and medical devices. Section 721(a) of the Federal Food Drug, and Cosmetic Act (the act) (21 U.S.C. 379e(a) provides that a color additive shall be deemed unsafe unless it meets the requirement of a listing regulation including any requirement for batch certification and is used in accordance with the regulation. FDA lists color additives that have been shown to be safe for their intended uses in Title 21 of the Code of Federal regulations.( CFR). FDA requires batch certification for all color additives provisionally listed in 21 CFR part 82. Color additives listed in 21 CFR part 73 are exempted from certification. The requirements for color additive certification are described in 21 CFR part 80. 2014-04-30-04:00 Active Denver Presley 3018271462 No No No 17760 2782 0

Reporting - 21CFR 80.21- Color Additive Certification No Health Consumer Health and Safety
3000 Color Certification Online Yes Yes Fillable Printable Form and instruction Form FDA 3000.doc Yes No Printable Only Instruction Form FDA 3000 Instructions ( User Guide).pdf
Private Sector 5920 1006 0

Reporting 21 CFR 80.22 - Color Additive Certification No Health Consumer Health and Safety
3000 Color Certification Online Yes Yes Fillable Printable Form and instruction Form FDA 3000.doc Yes No Printable Only Instruction Form FDA 3000 Instructions ( User Guide).pdf
Private Sector 5920 296 0

Recordkeeping 21 CFR 80.39- Color Additive Certification No Health Consumer Health and Safety Private Sector 5920 1480 0

2011-04-25-04:00

0910-0230 201207-0910-003 0910
             
        "Adverse Drug Experience Reporting"
             
          
        
Sections 201, 502, 505, and 701 of the Federal Food, Drug, and Cosmetic Act require that marketed drugs be safe and effective. In order to know whether drugs that are not safe and effective are on the market, FDA must be promptly informed of adverse experiences occasioned by the use of marketed drugs. In order to help ensure this, FDA issued regulations at 21 CFR 310.305 and 314.80 to impose reporting and recordkeeping requirements on the drug industry that would enable FDA to take action necessary for protection of the public health from adverse drug experiences. 2015-08-31-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 415226 7312076 47000

Adverse Drug Experience Reporting -- 310.305(c)(5) No Health Public Health Monitoring Private Sector 3 3 0

Adverse Event Reporting--314.80(c)(1)(iii) No Health Public Health Monitoring Private Sector 5 5 0

Adverse Event Reporting -- 314.80(c)(2) No Health Public Health Monitoring Private Sector 15195 911700 25000

Adverse Event Recordkeeping -- 310.305(f) No Health Public Health Monitoring Private Sector 25 400 0

Adverse Drug Event Recordkeeping -- 314.80(i) No Health Public Health Monitoring Private Sector 399998 6399968 22000

2012-08-15-04:00

0910-0231 201311-0910-010 0910
             
        "Premarket Approval of Medical Devices - 21 CFR Part 814"
             
          
        
This ICR collects information from persons filing a PMA application or a PMA supplement with FDA for approval of certain class III medical devices. The PMA regulation establishes procedures that FDA utilizes in approving, denying, or withdrawing approval of any PMA. It provides specific, clear, and flexible instructions to applicants so those respondents know what information is required in a PMA. PMA supplements are also used by FDA to determine any additional action the agency must take to protect the public health. The data reported to FDA and the records that are maintained allow FDA and industry to make decisions and take actions to protect the public health from defective medical devices. 2017-01-31-05:00 Active JonnaLynn Capezzuto jonnalynn.capezzuto@fda.hhs.gov 301 827-4659 No No No 2650 111070 0

Premarket Approval of Medical Devices - 21 CFR Part 814 No Health Consumer Health and Safety Private Sector 2050 100870 0

Premarket Approval of Medical Devices: maintenance of records No Health Consumer Health and Safety Private Sector 600 10200 0

2014-01-03-05:00

0910-0233 201101-0910-006 0910
             
        "Patent Term Restoration"
             
          
        
The information collection deals with FDA's patent term restoration regulations on due diligence petitions for regulatory review period revision. When a patented product must receive FDA approval before marketing is permitted, the Patent and Trademark Office (PTO) may add a portion of FDA's review time to the term of a patent. Petitioners may request reductions in the regulatory review time if FDA marketing approval was not pursued with ``due diligence.'' 2014-02-28-05:00 Active Eliazabeth Berbakos 3018271482 No No No 3 160 0

Patent Term Restoration No Health Illness Prevention Private Sector 3 160 0

2011-02-27-05:00

0910-0249 201111-0910-008 0910
             
        "FDA Recall Regulations"
             
          
        
FDA's recall regulations provide guidance to manufacturers on recall responsibilities. The guidelines apply to all regulated products (i.e., food, including animal feed; drugs, including animal drugs; medical devices, including in vitro diagnostic products; cosmetics; and biological products intended for human use). 2015-03-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 35079 443820 0

FDA Recall Regulations No Health Public Health Monitoring Private Sector 35079 443820 0

2012-03-29-04:00

0910-0256 201310-0910-005 0910
             
        "Infant Formula Requirements"
             
          
        
This ICR supports the recordkeeping, reporting, and labeling requirements for the manufacture and distribution of infant formula. Respondents to this collection are infant formula manufacturers who must ensure that their products adhere to the quality control procedures found in FDA regulations, and that nutrient information and directions for use are disclosed in their product labeling. 2016-01-31-05:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 218 30202 0

Requirements for Infant Formula No Health Consumer Health and Safety Private Sector 65 650 0

Infant Formula; Ingredient Control No Health Consumer Health and Safety Private Sector 1 4 0

Exampt Infant Formula; Terms and Conditions No Health Consumer Health and Safety Private Sector 6 24 0

Exempt Infant Formula; Notification Requirements No Health Consumer Health and Safety Private Sector 1 4 0

Exempt Infant Formula; Recordkeeping Requirements No Health Consumer Health and Safety Private Sector 30 9000 0

Infant Formula; Recordkeeping Requirements No Health Consumer Health and Safety Private Sector 50 20000 0

Infant Formula; Labeling (3rd Party Disclosure) Requirements No Health Consumer Health and Safety Private Sector 65 520 0

2014-01-29-05:00

0910-0264 201307-0910-002 0910
             
        "Export of Medical Devices - Foreign Letters of Approval"
             
          
        
Exportation of an unapproved device may be permitted under certain circumstances if the exportation is not contrary to the public health and safety and it has the approval of the foreign country to which it is intended for export. Requesters communicate (either directly or through a business associate in the foreign country) with a representative of the foreign government to which they seek exportation, and written authorization must be obtained from the appropriate office within the foreign government approving the importation of the medical device. An alternative to obtaining written authorization from the foreign government is to accept a notarized certification from a responsible company official in the United States that the product is not in conflict with the foreign country's laws. This certification must include a statement acknowledging that the responsible company official making the certification is subject to certain statutory provisions that make it a criminal offense to knowingly and willingly make a false or fraudulent statement, or make or use a false document, in any manner within the jurisdiction of a department or agency of the United States. The respondents to this collection of information are companies that seek to export medical devices. FDA's estimate of the reporting burden is based on the experience of FDA's medical device program personnel. 2016-08-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 38 114 9500

Export of Medical Devices - Foreign Letters of Approval No Health Consumer Health and Safety Private Sector 38 114 9500

2013-08-16-04:00

0910-0275 201203-0910-003 0910
             
        "State Enforcement Notifications "
             
          
        
Section 310(b) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 337(b)) authorizes States to enforce certain sections of the act in their own names, but provides that States must notify FDA before doing so. Section 100.2(d) (21 CFR 100.2 (d)) sets forth the information that a State must provide to FDA in a letter of notification when it intends to take enforcement action under the act against a particular food located in the State. 2015-06-30-04:00 Active Denver Presley 3018271462 No No No 1 10 0

State Enforcement Notifications No Health Consumer Health and Safety State, Local, and Tribal Governments 1 10 0

2012-06-11-04:00

0910-0277 201108-0910-011 0910
             
        "State Petitions for Exemption from Preemption"
             
          
        
Under section 403A(b) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343-1(b)), States may petition FDA for exemption from Federal preemption of State food labeling and standard of identity requirements. The information required under 21 CFR 100.1(d) enables FDA to determine whether the State food labeling or standard of identity requirement satisfies the criteria of section 403A(b) of the act for granting exemption from Federal preemption. 2014-10-31-04:00 Active Denver Presley 3018271462 No No No 1 40 0

Reporting - State Petitions for Exemption from Preemption No Health Consumer Health and Safety State, Local, and Tribal Governments 1 40 0

2011-10-23-04:00

0910-0284 201104-0910-005 0910
             
        "Records and Reports Concerning Experience with Approved New Animal Drugs"
             
          
        
The continuous monitoring of approved New Animal Drug Applications affords the primary means by which FDA obtains information regarding potential problems in safety and effectiveness of marketed animal drugs and potential manufacturing problems. Adverse reaction reports are required to be submitted by the drug manufacturer on FDA forms 1932 and 1932a( voluntary reporting form), following complaints from animal owners or veterinarians . Also product defects and lack of effectiveness complaints are submitted to FDA by the drug manufacturer following their own detection of a problem or complaints from product users or their veterinarians using forms FDA 1932 and 1932a. Form 2301 is used to submit the required transmittal reports and promotional material for new animal drugs. 2014-12-31-05:00 Active Denver Presley 3018271462 No No No 26969 111776 0

Records and Reports Concerning Experience with Approved New Animal Drugs No Health Consumer Health and Safety
Form FDA 1932 Veterinary Adverse Drug Reaction; Lack of Effectiveness or Product Defect Report Yes Yes Fillable Printable Form and instruction FDA-1932.pdf
Private Sector 17881 17881 0

Reporting: Adverse Drug Experience & Product / Manufacturing Defects Voluntary reporting Using Form FDa 1932a No Health Consumer Health and Safety
1932a Veterinary Adverse Drug Reaction, Lack of Effectiveness Yes Yes Fillable Printable Form and instruction Form FDA 1932a.pdf
Private Sector 82 82 0

Reporting: six Month Periodic Drug experience report ( Submit Annually After First 2 Years) Form FDA 2301 No Health Consumer Health and Safety
2301 Transmittal of Periodic Reports and Promotional Material No No Paper Only Form and instruction Form FDA 2301.pdf
Private Sector 1428 22848 0

Reporting: Requirement for Submission of Special Drug Experience Report More Frequently - Form FDA 2301 No Health Consumer Health and Safety
2301 Transmittal of Periodic Reports and Promotional Material No No Paper Only Form and instruction Form FDA 2301.pdf
Private Sector 26 52 0

Reporting: Requirement for Submitting Advertisement & Promotional Material - Form FDA 2301 No Health Consumer Health and Safety Private Sector 2849 5698 0

Reporting: Requirement for submitting Distributor statements - Form FDA 2301 No Health Consumer Health and Safety
2301 Transmittal of Periodic reports and Promotional Material No No Paper Only Form and instruction Form FDA 2301.pdf
Private Sector 52 98 0

Recordkeeping: Maintainence of Records ( data) by Applicants & Non Applicants That Was Not Submitted as Part of the NADA Application No Health Consumer Health and Safety Private Sector 4651 65117 0

2011-12-12-05:00

0910-0291 201206-0910-012 0910
             
        "MedWatch:  The FDA Medical Products Reporting Program"
             
          
        
This information collection covers the reporting associated with the MedWatch program. 2015-06-30-04:00 Active Jonnalynn Capezzuto 3018274659 No No No 786773 853585 0

MedWatch 3500 for VOLUNTARY reporting of adverse events, product problems and product use errors No Health Public Health Monitoring
FDA 3500 MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors No No Fillable Fileable Form and instruction Medwatch 3500 VOLUNTARY.pdf
Private Sector 22700 13620 0

MedWatch 3500B Consumer reporting No Health Public Health Monitoring
FDA 3500b MedWatch Consumer Reporting Yes Yes Fillable Fileable Form and instruction MedWatch 3500B Consumer Reporting.pdf
Private Sector 11500 4792 0

MedWatch 3500a for use by user-facilities, importers, distributors and manufacturers for MANDATORY reporting No Health Public Health Monitoring
FDA 3500a MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting Yes Yes Fillable Fileable Form and instruction MedWatch 3500a MANDATORY reporting.pdf
Private Sector 752573 835173 0

2012-06-29-04:00

0910-0297 201211-0910-001 0910
             
        "Prescription Drug User Fee Cover Sheet; Form FDA 3397"
             
          
        
Under the prescription drug user fee provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (sections 735 and 736 (21 U.S.C. 379g and 379h)), as amended, FDA has the authority to assess and collect user fees for certain drug and biologics license applications and supplements. The Prescription Drug User Fee Cover Sheet, Form FDA 3397, is required to be included with each applicable new drug application (NDA), biologics license application (BLA), and supplemental application to an NDA or BLA submitted to FDA for review. The Prescription Drug User Fee Cover Sheet is designed to provide the minimum necessary information to determine whether a fee is required for the review of an application, to determine the amount of the fee required, and to account for and track user fees. The information collected is used by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to initiate the administrative screening of new drug applications, biologics license applications and/or supplemental applications to those applications. 2015-12-31-05:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 4131 2066 0

Prescription Drug User Fee Cover Sheet; Form FDA 3397 No Health Public Health Monitoring
3397 Prescription Drug User Fee Cover Sheet Yes Yes Fillable Printable Form and instruction PDUFA FORM FDA 3397 10-5-12.pdf
Private Sector 4131 2066 0

2012-12-27-05:00

0910-0298 201310-0910-006 0910
             
        "Food Additives; Threshold of Regulation for Substances Used in Food-Contact Articles"
             
          
        
This ICR collects information regarding whether a food contact substance falls within the regulatory threshold criteria provided for by FDA regulations. Respondents to this collection are individual manufacturers and suppliers of substances used in food-contact articles, such as food packaging and food processing equipment, or the articles themselves. 2017-01-31-05:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 7 336 0

Food Additives; Threshold of Regulation for Substances Used in Food-Contact Articles No Health Consumer Health and Safety Private Sector 7 336 0

2014-01-15-05:00

0910-0302 201312-0910-010 0910
             
        "Human Tissue Intended for Transplantation"
             
          
        
The information collection requirements help prevent the transmission of communicable diseases through human tissue transplantation by requiring that written SOPs be prepared and followed for the following: (1) infectious disease testing; (2) determining the medical history of the donor; (3) designating and identifying quarantined tissue; and (4) preventing infectious disease contamination or cross-contamination of tissue during processing. The regulations require maintenance of records of all significant steps in the infectious disease testing, and screening, and require that these records be made available for FDA inspection. Adequate donor screening and testing must be recorded so that the suitability of the tissue can be determined. If FDA is unable to ascertain how a tissue donor was screened or tested, or if the tissue was distributed in violation of the regulations, then recall, retention, and/or destruction orders may be issued by FDA in accordance with codified administrative procedures. 2017-01-31-05:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 806011 806770 0

Written Procedures -- 1270.31(a), (b), (c), and (d) No Health Consumer Health and Safety Private Sector 33 792 0

Written Procedures -- 1270.31(a) and (b) No Health Consumer Health and Safety Private Sector 66 66 0

Records, General Requirements -- 1270.33(a), (f), and (h), and 1270.35(a) and (b) No Health Consumer Health and Safety Private Sector 254570 254570 0

Specific Records -- 1270.35(c) No Health Consumer Health and Safety Private Sector 490082 490082 0

Specific Records -- 1270.35(d) No Health Consumer Health and Safety Private Sector 61260 61260 0

2014-01-27-05:00

0910-0303 201107-0910-009 0910
             
        "Electronic Records:  Electronic Signatures"
             
          
        
This regulation requires/specifies (1) Procedures and controls for persons who use closed or open systems to create, modify, maintain, or transmit electronic records, (2) procedures and controls for persons who use electronic signatures, (3) controls to ensure the security and integrity of electronic signatures based upon use of identification codes in combination with passwords. Some or all of the procedures and controls will need to be incorporated in written standard operating procedures. Ths use of electronic records as well as their submission to FDA is voluntary. 2014-10-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 4500 284500 0

Electronic Records: Electronic Signatures No Health Public Health Monitoring Private Sector 4500 284500 0

2011-10-31-04:00

0910-0308 201107-0910-007 0910
             
        "Adverse Experience Reporting for Licensed Biological Product; and General Records"
             
          
        
The primary purpose of FDA's Adverse Experience Reporting (AER) system is to identify potentially serious safety problems with licensed biological products, focusing especially on newly licensed products. Although premarket testing discloses a general safety profile of a new drug's comparatively common adverse effects, the larger and more diverse patient populations exposed to the licensed biological product provides, for the first time, the opportunity to collect information on rare, latent, and long-term effects. AER reports are obtained from a variety of sources, including manufacturers, patients, physicians, foreign regulatory agencies, and clinical investigators. The general recordkeeping provisions require manufacturers of licensed biological products for human use to maintain records of each step in the manufacture and distribution of products. The recordkeeping requirements serve preventative and remedial purposes by establishing accountability and traceability in the manufacture and distribution of products. 2014-11-30-05:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 296769 2096444 0

600.80(c)(1) and 600.80(e) No Health Consumer Health and Safety Private Sector 86583 86583 0

600.80(c)(2) No Health Consumer Health and Safety Private Sector 57300 1604400 0

600.81 No Health Consumer Health and Safety Private Sector 349 349 0

600.91 No Health Consumer Health and Safety Private Sector 21 21 0

600.12 No Health Consumer Health and Safety Private Sector 6752 216064 0

600.12(b)(2) No Health Consumer Health and Safety Private Sector 1881 45144 0

600.80(i) No Health Consumer Health and Safety Private Sector 143883 143883 0

2011-11-06-05:00

0910-0309 201307-0910-001 0910
             
        "Mammography Facilities, Standards, and Lay Summaries for Patients"
             
          
        
Under the regulations, as a first step in becoming certified, mammography facilities must become accredited by an FDA approved accreditation body (AB). This requires undergoing a review of their clinical images and providing the AB with information showing that they meet the equipment, personnel, quality assurance and quality control standards, and have a medical reporting and recordkeeping program, a medical outcomes audit program, and a consumer compliant mechanism. On the basis of this accreditation, facilities are then certified by FDA or an FDA-approved State certification agency and must prominently display their certificate. These actions are taken to ensure safe, accurate, and reliable mammography on a nationwide basis. 2016-08-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 35208523 3940842 24410106

Mammography Facilities, Standards, and Lay Summaries for Patients No Health Consumer Health and Safety
FDA 3422 GOVERNMENTAL ENTITY DECLARATION Yes Yes Fillable Fileable Signable Form and instruction Form FDA 3422.pdf
Private Sector 35208523 3940842 24410106

2013-08-16-04:00

0910-0312 201304-0910-003 0910
             
        "Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents"
             
          
        
This is a request for OMB renewal for FDA's regulations for cigarettes and smokeless tobacco containing nicotine. The codified regulations at 21 CFR Part 1140 are authorized by section 102 of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31). This collection includes reporting information requirements for amp;#167; 1140.30, which directs persons to notify FDA if they intend to use a form of advertising that is not addressed in the regulations. As the public is being advised through the FDA guidance entitled "Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco," the recordkeeping and disclosure requirements under section 1140.32 are not being enforced, and therefore, FDA is including 2 hours of burden as placeholders with this provision. 2016-07-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 302 302 0

Format and Content Requirements for labeling and advertising - 3rd party No Health Consumer Health and Safety Private Sector 1 1 0

Scope of permissible forms of labeling and advertising No Health Consumer Health and Safety Private Sector 300 300 0

Format and content requirements for labeling and advertising No Health Consumer Health and Safety Private Sector 1 1 0

2013-07-16-04:00

0910-0320 201011-0910-004 0910
             
        "Request for Information from U.S. Processors that Export to the European Community"
             
          
        
The European Council (EC) directive 2003/863/EC requires that shipments of raw, bulk collagen and gelatin products be accompanied by certification stating that the product, derived from ruminant bones, bovine hides and pigskins has been produced in compliance with this directive. The directive contains the requirements for sourcing, manufacture, transport and storage of raw materials and manufacture of finished products. Article 23 of Chapter III of the directive requires a list identifying the non-EC firms and processors that meet EC requirements and has appropriate animal and public health certificates. 2014-02-28-05:00 Active Denver Presley 3018271462 No No No 146 37 0

Reporting - Request for Information from U.S. Processors that Export to the European Community - Shell Eggs No Health Consumer Health and Safety Private Sector 10 3 0

Reporting: Request for Information from U.S. Processors that Export to the European Community - Dairy No Health Consumer Health and Safety Private Sector 120 30 0

Reporting: Request for Information from U.S. Processors that Export to the European Community - Game Meat & Game Meat Products No Health Consumer Health and Safety Private Sector 5 1 0

Reporting: Request for Information from U.S. Processors that Export to the European Community - Animal Casings No Health Consumer Health and Safety Private Sector 3 1 0

Reporting: Request for Information from U.S. Processors that Export to the European Community - Gelatin No Health Consumer Health and Safety Private Sector 5 1 0

Reporting: Request for Information from U.S. Processors that Export to the European Community - Collagen No Health Consumer Health and Safety Private Sector 3 1 0

2011-02-27-05:00

0910-0322 201302-0910-005 0910
             
        "Enviornmental Impact Considerations"
             
          
        
FDA is requesting OMB approval for the reporting requirements contained in the FDA collection of information "Environmental Impact Considerations." The National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4347) states national environmental objectives and imposes upon each Federal agency the duty to consider the environmental effects of its actions that will significantly affect the quality of the human environment. The FDA NEPA regulations are contained in 21 CFR part 25. All applications or petitions requesting Agency action require the submission of a claim for a categorical exclusion or an environmental assessment (EA). This collection of information is used by FDA to assess the environmental impact of Agency actions and to ensure that the public is informed of environmental analyses. Firms wishing to manufacture and market substances regulated under statutes for which FDA is responsible must, in most instances, submit applications requesting approval. Environmental information must be included in such applications for the purpose of determining whether the proposed action may have a significant impact on the environment. Where significant adverse effects cannot be avoided, the Agency uses the submitted information as the basis for preparing and circulating to the public an EIS, made available through a FEDERAL REGISTER notice also filed for comment at the Environmental Protection Agency (EPA). If the Agency finds that no significant environmental effects are expected, the Agency prepares a FONSI. The respondents to this collection are primarily from the private sector businesses. 2016-05-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 14188 188430 0

Enviornmental Impact Considerations No Health Public Health Monitoring Private Sector 14188 188430 0

2013-05-23-04:00

0910-0325 201111-0910-006 0910
             
        "Extra Label Drug Use in Animals"
             
          
        
The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), amended the FD&C Act to allow licensed veterinarians to prescribe extralabel uses in animals of approved drugs. Under AMDUCA, FDA may establish by regulation or order a safe residue level for an extralabel use and may require development of an analytical method for residue detection if it finds there is a resonable probability of a risk to public health. 2015-02-28-05:00 Active Denver Presley 3018271462 No No No 2 8320 0

Extralabel Drug Use in Animals No Health Consumer Health and Safety Private Sector 2 8320 0

2012-02-06-05:00

0910-0330 201311-0910-012 0910
             
        "Premarket Notification for a New Dietary Ingredient"
             
          
        
This information collection supports the premarket notification requirements for a new dietary ingredient (NDI). Respondents include manufacturers, distributors, packagers, holders, labelers, exporters, and importers of dietary supplements that contain NDIs who must report product information to FDA at least 75 days before an NDI or a dietary supplement that contains an NDI can be introduced or delivered into interstate commerce. 2015-02-28-05:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 55 1100 0

Reporting - Submission of a Premarket Notification for a New Dietary Ingredient No Health Consumer Health and Safety Private Sector 55 1100 0

2014-02-12-05:00

0910-0331 201303-0910-006 0910
             
        "Food Labeling:  Notification Procedures for Statements on Dietary Supplements"
             
          
        
The reporting requirements of this regulation implement the Dietary Supplement Health and Education Act. The subject regulation establishes reporting procedures necessary to inform FDA when dietary supplement manufacturers are making statements of nutritional support on their labels or in their labeling. 2016-05-31-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 2200 1650 0

Certain Types of Statements for Dietary Supplements No Health Consumer Health and Safety Private Sector 2200 1650 0

2013-05-23-04:00

0910-0332 201212-0910-004 0910
             
        "Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H"
             
          
        
The information gathered by this collection activity enables FDA to determine whether an HDE holder is in compliance with the HDE requirements. It also allows FDA to determine whether to: (1) Grant HUD designation of a medical device, (2) exempt a HUD from the effectiveness requirements under sections 514 and 515 of the act (21 U.S.C.360d and 360e)provided that the device meets requirements set forth in section 520m of the act, and (3)grant marketing approval(s)for HUD. Failure to collect this information would prevent FDA from making that determination. 2015-02-28-05:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 154 12585 0

Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H No Health Consumer Health and Safety Private Sector 154 12585 0

2012-12-17-05:00

0910-0337 201305-0910-004 0910
             
        "Medicated Fee Mill License Application"
             
          
        
The paperwork process has been streamlined for gaining approval to manufacture medicated feeds by replacing the Medicated Feed Application system with a facility license for each medicated feed manufacturing facility. The information required from the medicated feed manufacturing facility will be used to determine if a medicated feed mill license application will be approved or refused. 2016-08-31-04:00 Active JonnaLynn Capezzuto jonnalynn.capezzuto@fda.hhs.gov 301 827-4659 No No No 1051 58 0

Medicated Feed Mill License Application Using Form FDA 3448 No Health Consumer Health and Safety
FDA 3448 Medicated Feed Mill License Application Yes No Fillable Printable Form and instruction 0337 form FDA 3448 5-1-13.pdf
Private Sector 20 5 0

Supplemental Medicated Feed Mill License Application; Form FDA 3448 No Health Consumer Health and Safety
FDA 3448 Medicated Feed Mill License Application Yes No Fillable Printable Form and instruction 0337 form FDA 3448 5-1-13.pdf
Private Sector 40 10 0

Voluntary Revocation of Medicated Feed Mill License Application No Health Consumer Health and Safety Private Sector 40 10 0

Filing a Request fo a Hearing on a Medicated Feed Mill License Application No Health Consumer Health and Safety Private Sector 1 4 0

Maintenance of Records for Appoved Labeling fo Each "Type B" and "Type C" Labeling No Health Consumer Health and Safety Private Sector 950 29 0

2013-08-15-04:00

0910-0338 201311-0910-007 0910
             
        "General Licensing Provisions:  Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h & 2567"
             
          
        
Manufacturers are required to submit a license application for review and approval prior to marketing a biological product in interstate commerce. In addition, manufacturers must submit to FDA advertising and promotional labeling. Manufacturers are also required to sbumit changes, including labeling, changes to an approved application, as well as advertising and promotional labeling changes. The information submitted to FDA in a biologics license application (BLA), supplement to an approved application, or other similar submission is used to determin if a product is safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use. Forms FDA 356h and 3567 have been developed for use by the industry to insure that all the required and necessary information concerning licensing and labeling is submitted to FDA. The regulations also describe the types of postmarketing studies that reuqire status reports, the information to be included in the reports, and the type of information that FDA would consider appropriate for public disclosure. FDA uses the information submitted from the reports of postmarketing studies to meet its reporting obligations under section 506B of the Federal Food, Drug, and Comsetic Act and section 130(b) of the Food and Drug Administration Modernization Act and corresponding regulations. 2017-01-31-05:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 28805 324761 0

601.2(a) - Applications for Biologics Licenses; procedures for filing and 610.60 through 610.65 - Container Label No Health Consumer Health and Safety
356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip 2567 Transmittal of Labels and Circulars Yes Yes Fillable Printable Form and instruction FORM 2567 11-5-13.pdf
Private Sector 45 38700 0

601.5(a) - Revocation of License No Health Consumer Health and Safety
356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip 2567 Transmittal of Labels and Circulars Yes Yes Fillable Printable Form and instruction FORM 2567 11-5-13.pdf
Private Sector 8 3 0

601.6(a) - Suspension of License No Health Consumer Health and Safety
2567 Transmittal of Labels and Circulars Yes Yes Fillable Printable Form and instruction FORM 2567 11-5-13.pdf 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip
Private Sector 1 0 0

601.12(a)(5) - Changes to an Approved Application No Health Consumer Health and Safety
356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip 2567 Transmittal of Labels and Circulars Yes Yes Fillable Printable Form and instruction FORM 2567 11-5-13.pdf
Private Sector 13059 13059 0

601.12(b)(1)/(b)(3)/(e) - Changes to an Approved Application No Health Consumer Health and Safety
2567 Transmittal of Labels and Circulars Yes Yes Fillable Printable Form and instruction FORM 2567 11-5-13.pdf 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip
Private Sector 698 55840 0

601.12(c)(1) and (c)(3) - Changes to an Approved Application No Health Consumer Health and Safety
2567 Transmittal of Labels and Circulars Yes Yes Fillable Printable Form and instruction FORM 2567 11-5-13.pdf 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip
Private Sector 538 26900 0

601.12(c)(5) - Changes to an Approved Application No Health Consumer Health and Safety
2567 Transmittal of Labels and Circulars No No Fillable Printable Form and instruction FORM 2567 11-5-13.pdf 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.pdf
Private Sector 29 1450 0

601.12(d)(1)/(d)(3)/(f)(3) - Changes to an Application No Health Consumer Health and Safety
2567 Transmittal of Labels and Circulars Yes Yes Fillable Printable Form and instruction FORM 2567 11-5-13.pdf 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip
Private Sector 742 17808 0

601.12(f)(1) - Changes to an Approved Application No Health Consumer Health and Safety
356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip 2567 Transmittal of Labels and Circulars Yes Yes Fillable Printable Form and instruction FORM 2567 11-5-13.pdf
Private Sector 166 6640 0

601.12(f)(2) - Changes to an Approved Application No Health Consumer Health and Safety
356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip 2567 Transmittal of Labels and Circulars Yes Yes Fillable Printable Form and instruction FORM 2567 11-5-13.pdf
Private Sector 128 2560 0

601.12(f)(4)/601.45 - Changes to an Approved Application No Health Consumer Health and Safety
2567 Transmittal of Labels and Circulars Yes Yes Fillable Printable Form and instruction FORM 2567 11-5-13.pdf 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip
Private Sector 10578 105780 0

601.26(f) - Additional Studies and Labeling No Health Consumer Health and Safety
356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip 2567 Transmittal of Labels and Circulars Yes Yes Fillable Printable Form and instruction FORM 2567 11-5-13.pdf
Private Sector 1 1 0

601.27(b) - Pediatric Studies - Deferred Submission No Health Consumer Health and Safety
2567 Transmittal of Labels and Circulars Yes Yes Fillable Printable Form and instruction FORM 2567 11-5-13.pdf 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip
Private Sector 4 96 0

601.27(c) - Pediatric Studies No Health Consumer Health and Safety
356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip 2568 Transmittal of Labels and Circulars Yes Yes Fillable Printable Form and instruction FORM 2567 11-5-13.pdf
Private Sector 6 48 0

601.70(b) and (d)/601.28 - Annual Progress Reports of Postmarketing Studies and Annual reports of postmarketing pediatric studies No Health Consumer Health and Safety
2567 Transmittal of Labels and Circulars Yes Yes Fillable Printable Form and instruction FORM 2567 11-5-13.pdf 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip
Private Sector 107 2568 0

610.15(d) - Constituent Materials No Health Consumer Health and Safety
356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip 2567 Transmittal of Labels and Circulars Yes Yes Fillable Printable Form and instruction FORM 2567 11-5-13.pdf
Private Sector 1 1 0

680.1(c) - Allergenic Products No Health Consumer Health and Safety
2567 Transmittal of Labels and Circulars No No Fillable Printable Form and instruction FORM 2567 11-5-13.pdf 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip
Private Sector 9 18 0

680.1(b)(3)(iv) - Allergenic Products No Health Consumer Health and Safety
2567 Transmittal of Labels and Circulars Yes Yes Fillable Printable Form and instruction FORM 2567 11-5-13.pdf 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip
Private Sector 1 2 0

Amendments/Resubmissions No Health Consumer Health and Safety
356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.zip
Private Sector 2664 53280 0

601.6(a) - Suspension of License No Health Consumer Health and Safety
356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use Yes Yes Fillable Printable Form and instruction FORM FDA 356h 11-5-13.pdf
Private Sector 20 7 0

2014-01-03-05:00

0910-0339 201309-0910-008 0910
             
        "Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed"
             
          
        
Respondents to the recordkeeping requirements for this collection are persons who manufacture, blend, process, and distribute products that contain or may contain protein derived from mammalian tissue, and feeds made from such products. The requirements provide that written procedures be developed to protect against animal feed contamination that would potentially spread disease. This information collection was established because epidemiological evidence gathered in the United Kingdom suggested that bovine spongiform encephalopathy (BSE), a progressively degenerative central nervous system disease, is spread to ruminant animals by feeding protein derived from ruminants infected with BSE. 2016-10-31-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 400 5600 0

Recordkeeping: Requirement for Maintainence of Written Procedures to Ensure Separation of Mammaliamn Protein From Non-Mammalian Protein Intended for Use in Ruminant Feed No Health Consumer Health and Safety Private Sector 400 5600 0

2013-10-23-04:00

0910-0340 201312-0910-009 0910
             
        "Over-the-Counter Human Drugs; Labeling Requirements"
             
          
        
Regulations established in March 1999 (21 CFR 206.66) define format and content requirements for the labeling of over-the-counter (OTC)drug products. Specifically, these requirements apply to labeling within the Drug Facts panel required for all OTC drug products (i.e., "Drug Facts" labeling). All OTC drug products except sunscreens have been required to comply with the labeling requirements set forth in 21 CFR 206.66 since June 2005. Complying with these regulations imposes a burden on the manufacturers of new OTC drug products. The burden consists of preparing new labeling for these products that complies with the Drug Facts labeling requirements 2017-01-31-05:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 961 11523 2100000

Format and Content Requirements for Over--the-Counter Drug Product Labeling - 201.66(c) and (d) - New OTC Drug Products No Health Consumer Health and Safety Private Sector 900 10800 2100000

Format and Content Requirements for Over-the-Counter Drug Product Labeling - 201.66(c)&(d) - New OTC Sunscreen Products No Health Consumer Health and Safety Private Sector 60 720 0

Format and Content Requirements -- Exemptions and Deferrals -- 201.66(e) No Health Consumer Health and Safety Private Sector 1 3 0

2014-01-27-05:00

0910-0341 201103-0910-008 0910
             
        "FDA Public Health Notification (formerly known as Safety Alert/ Public Health Advisory) Readership survey"
             
          
        
The survey would collect information from a sample of FDA Public Health Notification recipients. FDA will use the information to evaluate the usefulness of these publications and to improve its methods of communicating medical device risks to health care practitioners. 2014-06-30-04:00 Active Denver Presley 3018271462 No No No 924 157 0

FDA Public Health Notification (formerly known as Safety Alert/ Public Health Advisory) Readership survey No Health Consumer Health and Safety Private Sector 924 157 0

2011-06-27-04:00

0910-0342 201211-0910-010 0910
             
        "Substances Generally Recognized as Safe:  Notification Procedure"
             
          
        
This ICR collects information from food manufactures who wish to obtain a determination from the Agency that a food additive is generally recognized as safe (GRAS) and therefore not subject to premarket approval requirements. Respondents submit information as provided in Agency regulations regarding GRAS notification, including a description of the substance, intended use, previous communications with the Agency, contact information, etc. FDA has developed Form 3667 to facilitate its review of information being submitted so that a GRAS determination can be made. Food additives that are not GRAS must obtain premarket approval. 2016-02-29-05:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 60 9900 0

GRAS Notice for 21 CFR 170.36 No Health Consumer Health and Safety
FDA 3667 GRAS Notice Yes Yes Fillable Fileable Form FDA-3667_V06.pdf Yes No Printable Only Instruction Instructions for completing Form 3667.pdf
Private Sector 60 9900 0

2013-02-18-05:00

0910-0354 201311-0910-011 0910
             
        "Procedures for the Safe Processing and Importing of Fish and Fishery Products"
             
          
        
This information collection request covers recordkeeping responsibilities covered in FDA regulations regarding the safe processing, handling, and packaging of seafood. Respondents are processors and importers of seafood who must record and verify various safety measures including the establishment and maintenance of procedural operations, hazard analysis, sanitation control, and product testing. 2017-02-28-05:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 9860091 1930264 0

Recordkeeping: Requirement for Processors to Prepare , Implement & Maintain Records of a Written HACCP Plan If Hazard Analysis Shows Food Safety Hazzads Are Likely to Occur No Health Consumer Health and Safety Private Sector 50 800 0

Recordkeeping: Requirement For Processors To Incorporate A Corrective Action Plan Within Their Written HACCP Plan No Health Consumer Health and Safety Private Sector 60000 18000 0

Recordkeeping: Verification Requirements for Processors That Their HACCP Plan Is Adequate to Control Food Safety Hazards No Health Consumer Health and Safety Private Sector 15000 60000 0

Recordkeeping: Requirement for Importers of Seafood Products to Verify Compliance of Imports and Maintain Records No Health Consumer Health and Safety Private Sector 328000 65600 0

Recordkeeping: Requirement for Processors to Implement a Recordkeeping System That Documents The Monitoring of The Critical Control Points No Health Consumer Health and Safety Private Sector 4200000 1260000 0

Recodkeeping: Requirement That Processors Maintain Records of Any Corrective Action When a Deviation From A Critical Limit Occurs No Health Consumer Health and Safety Private Sector 24000 2400 0

Recordkeeping: Requirement That Processors Maintain Records of The Calibration of "Process-Monitoring" Instruments and The Performing of Any " Periodic End Product and In - Process Testing." No Health Consumer Health and Safety Private Sector 705000 70500 0

Recodkeeping: Requirement for Processors to Maintain Sanitation Control Records No Health Consumer Health and Safety Private Sector 4200000 420000 0

Recordkeeping: Maintainance of Records by Importers of Seafood Products That Fish & Fishery Products Offered For Import Were Processed in Accordance With the HACCP & Sanitation Provisions No Health Consumer Health and Safety Private Sector 328000 32800 0

Recordkeeping: Verification Procedure Requirements for Importers of Fish and Fishery Products Offered fo Import into the U.S. No Health Consumer Health and Safety Private Sector 41 164 0

2014-02-07-05:00

0910-0359 201103-0910-007 0910
             
        "Medical Devices; Reports of Corrections and Removals"
             
          
        
The information collection requirements in 21 CFR Part 806 require each device manufacturer or importer to submit a written report to FDA of any action to correct or remove a device which may present a risk to health within 10-working days of initiating such correction or removal. The Information Collection also requires that each device manufacturer or importer of a device who initiates a correction or removal of a device that is not required to be reported to FDA, shall keep a record of such correction or removal. 2014-05-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 756 7560 0

Medical Devices; Reports of Corrections and Removals No Health Consumer Health and Safety Private Sector 756 7560 0

2011-05-02-04:00

0910-0360 201107-0910-011 0910
             
        "Customer/Partner Service Surveys - (Extension)"
             
          
        
This generic ICR will allow FDA to conduct customer satisfaction surveys to gain important feedback from all FDA-regulated industries. 2014-09-30-04:00 Active Jonnalynn Capezzuto 3018274659 No No No 30000 7500 0

Training Program Surveys for FDA State Tobacco Compliance Check Inspection Training Program and FDA/Center for Tobacco Products/Annual Program Coordinators' Conference No Health Immunization Management State, Local, and Tribal Governments 645 261 0

FDA Tobacco Regulatory Requirement Information Survey No Health Immunization Management Private Sector 200 50 0

FDA/CTP Training Program Surveys for FDA's Center for Tobacco Products Office of Compliance and Inspection 2012 Annual Training Conference No Health Immunization Management State, Local, and Tribal Governments 86 22 0

FDA 360 Consumer Satisfaction No Health Immunization Management Individuals or Households 1000 167 0

FDA/CTP Office of Compliance and Enforcement 2013 Annual Retail Compliance Check Inspection Program Training No Health Immunization Management State, Local, and Tribal Governments 100 25 0

2011-09-06-04:00

0910-0363 201111-0910-003 0910
             
        "Veterinary Feed Directive"
             
          
        
A VFD drug is a drug intended for use in animal feeds which is limited to use under the professional supervision of a licensed veterinarian. This regulation establishes the requirements for the distribution and use of VFD drugs and animal feeds containing VFD drugs. 2014-12-31-05:00 Active Denver Presley 3018271462 No No No 1880521 120134 0

Veterinary Feed Directive No Health Consumer Health and Safety Private Sector 1880521 120134 0

2011-12-20-05:00

0910-0374 201112-0910-004 0910
             
        "Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body"
             
          
        
This guidance provides information to industry for submission of notifications of a health claim or nutrient content claim based on an authoritative statement of a scientific body. Under Sections 303 and 304 of the FDA Modernization Act of 1997 (FDAMA), firms must submit such notifications to FDA 120 days before they begin marketing a food product that bears a health claim or a nutrient content claim that is based upon an authoritative statement of a scientific body. 2015-03-31-04:00 Active Denver Presley 3018271462 No No No 4 702 0

Reporting: Guidance for Industry: - Notification of a Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body No Health Consumer Health and Safety Private Sector 1 250 0

Reporting: Guidance for Industry: Notification of a Health Claim Based on an Authoritative Statement of a Scientific Body No Health Consumer Health and Safety Private Sector 1 450 0

Reporting: Guidance for Industry: Requirement for Analytical Methodology Information Based on Authoritative Statement for Both Nutrient Content Claims and Health Claims Notifications No Health Consumer Health and Safety Private Sector 2 2 0

2012-03-29-04:00

0910-0375 201312-0910-005 0910
             
        "Medical Devices; Third Party Review Under FDAMA"
             
          
        
This ICR collects information from persons who wish to be accredited by the Agency to review certain premarket notifications. Participation in this third-party review program by accredited persons is entirely voluntary. A third party wishing to participate will submit a request for accreditation to FDA. Accredited third-party reviewers have the ability to review a manufacturer's premarket notification for selected medical devices. After reviewing a submission, the reviewer will forward a copy of the submission, along with the reviewer's documented review and recommendation to FDA. Third-party reviewers also maintain records of their reviews and a copy of the submission. The purpose of the program is: (1) to provide manufacturers of eligible devices with an alternative review process that could yield more rapid marketing clearance decisions and (2) enable FDA to target its scientific review resources at higher-risk devices while maintaining confidence in the review by third parties of low-to-moderate risk devices. 2017-01-31-05:00 Active JonnaLynn Capezzuto jonnalynn.capezzuto@fda.hhs.gov 301 827-4659 No No No 260 13024 0

Medical Devices; Third Party Review Under FDAMA: requests for accreditation, 510(k) reviews conducted by accredited third parties, 510(k) reviews No Health Consumer Health and Safety Private Sector 260 13024 0

2014-01-27-05:00

0910-0381 201008-0910-001 0910
             
        "Food Labeling Regulations"
             
          
        
Section 403 (21 U.S.C. 343) of the Federal Food, Drug, and Cosmetic Act (the act) establishes requirements that the label or labeling of a food product must meet so that it is not misbranded and subject to regulatory action. Certain of the provisions of section 403 require that food producers disclose information about themselves or their products on the labels or labeling of their products. FDA has issued various regulations in parts 101, 102, 104, and 105 (21 CFR parts 101, 102, 104, and 105) that also require food producers to disclose certain information on the labels or labeling of their food products. Related regulations require that food producers retain records establishing the basis for the information contained in the label or labeling of their products and provide those records to regulatory officials. Finally, certain regulations provide for the submission of food labeling petitions. FDAs food labeling regulations were issued under the authority of sections 4, 5, and 6 of the Fair Packaging and Labeling Act (the FPLA) (15 U.S.C. 1453, 1454, and 1455) and of sections 201, 301, 402, 403, 409, and 701 of the act (21 U.S.C. 321, 331, 342, 348, and 371). Most of the regulations in Parts 101, 102, 104, and 105 derive from the requirements of section 403 of the act, which provides that a food product shall be misbranded if, among other things, its label or labeling fails to bear certain required information concerning the food product, is false or misleading in any particular, or bears certain types of unauthorized claims. The disclosure requirements and other collections of information in the regulations in parts 101,102,104, and 105 are necessary to ensure that food products produced or sold in the United states are in compliance with labeling provisions of the act and the FPLA. 2014-02-28-05:00 Active Denver Presley 3018271462 No No No 2401288 1786023 0

Reporting: Small Business Nutrition Labeling Exemption Using Form FDA 3570 No Health Consumer Health and Safety
3570 Small Business Nutrition Labeling Exemption Notice Module Form Yes Yes Fillable Printable Form and instruction Small Business Nutrition Labeling Exemption Small Business Nutrition Labeling Exemption Notice Model Form.mht
Private Sector 10000 80000 0

Reporting: Petition To Establish or Amend a Reference Amount No Health Consumer Health and Safety Private Sector 5 400 0

Reporting: Petition for Nutrient Content Claims No Health Consumer Health and Safety Private Sector 3 75 0

Reporting: Petitions for Health Claims No Health Consumer Health and Safety Private Sector 5 400 0

Reporting: Written Proposal For Requesting Temporay Exemptions From Certain Requirements Under 21 CFR 101.9 & 105.66 For the Purposes of Conducting Food Labeling Experiments No Health Consumer Health and Safety Private Sector 1 40 0

Recordkeeping- Reference Amounts- Specific Requirements for Maintainence of Records For a Food Modified by Incorporating Air ( aerated) No Health Consumer Health and Safety Private Sector 25 25 0

Recordkeeping: Nutrient Content Claim - Requirement That Restaurants Document ( maintain records) and Provide to Appropriate Regulatory Officials Upon Request. No Health Consumer Health and Safety Private Sector 450000 337500 0

Recordkeeping : Health Claims- Specific Requirements for Maintaince of Records No Health Consumer Health and Safety Private Sector 450000 337500 0

Recordkeeping: Specifice Food Labeling Requirements - Maintainance of Certification Records by Flavor Suppliers No Health Consumer Health and Safety Private Sector 25 25 0

Recordkeeping:Exemptions From Food Labeling Requirements: Maintaince of Agreement Records that Forms the Basis For an Exemption From Labeling Requirements by Operator / Persons No Health Consumer Health and Safety Private Sector 1000 1000 0

Recordkeeping: Declaration of Net Quanty When Exempt - Requirement For Maintainance of Records in Which the Declaration of Net Quanity of Contents Does Not Accurately Reflect The Actual Quantity ... No Health Consumer Health and Safety Private Sector 100 100 0

Third Party Disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 25750 12875 0

Third Party Disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 25750 25750 0

Third Party Disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 25750 6438 0

Third Party Disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 2575 103000 0

Third Party Disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 12 48 0

Third Party Disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 450000 112500 0

Third Party Disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 67 67 0

Third Party Disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 25 25 0

Third Party Disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 5000 5000 0

Third Party Disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 200 200 0

Third Party Disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 5000 5000 0

Third Party Disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 450000 337500 0

Third Party Disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 1600 12800 0

Third Party Disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 25 25 0

Third Party Disclosure: Food Labeling Regulation No Health Consumer Health and Safety Private Sector 7500 7500 0

Third Party Disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 12000 48000 0

Third Party disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 1000 500 0

Third Party Disclosure: Food Labeling regulations No Health Consumer Health and Safety Private Sector 20 80 0

Third Party Disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 1000 250 0

Third Party Disclosure: Food Labeling regulations No Health Consumer Health and Safety Private Sector 100 25 0

Third Party Disclosure: Food Labeling Regulations No Health Consumer Health and Safety Private Sector 1000 1000 0

Third Party Disclosure: food Labeling Regulations No Health Consumer Health and Safety Private Sector 25750 12875 0

Third Party Disclosure: Food Labeling Requirements No Health Consumer Health and Safety Private Sector 450000 337500 0

2010-12-05-05:00

0910-0389 201108-0910-002 0910
             
        "Guidance for Industry:  Fast Track Drug Development Programs - Designation, Development, and Application Review"
             
          
        
This guidance is intended to articulate how FDA plans to work with sponsors to facilitate the development and expedite the review of new drugs, including biological products, intended to treat a serious or life-threatening condition and that demonstrate a potential to address an unmet medical need. Under Section 112(b) of Food and Drug Administration Modernization Act of 1997, FDA issued guidance to industry on fast track policies and procedures outlined in Section 506 of the Federal Food, Drug and Cosmetic Act, other sections of the Public Health Service Act, or implementing regulations. 2015-02-28-05:00 Active Eliazabeth Berbakos 3018271482 No No No 195 14780 0

Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review (Premeeting Packages) No Health Public Health Monitoring Private Sector 77 7700 0

Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review (Designation Request) No Health Public Health Monitoring Private Sector 118 7080 0

2012-02-06-05:00

0910-0393 201204-0910-003 0910
             
        "Prescription Drug Product Labeling; Medication Guide Requirements"
             
          
        
FDA regulations require the distribution of patient labeling, called Medication Guides, for certain prescription human drugs and biological products used primarily on an outpatient basis that pose a serious and significant public health concern requiring distribution of FDA-approved patient medication information. These Medication Guides inform patients about the most important information they should know about these products in order to use them safely and effectively. 2016-01-31-05:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 296719031 16907114 0

Initial Submissions No Health Public Health Monitoring Private Sector 25 8000 0

Revised Submissions No Health Public Health Monitoring Private Sector 5 360 0

Patient Disclosure No Health Public Health Monitoring Private Sector 295000000 14750000 0

Exemption/Deferral Requests No Health Public Health Monitoring Private Sector 1 4 0

Distributing and Dispensing a Medication Guide No Health Public Health Monitoring Private Sector 1719000 2148750 0

2013-01-14-05:00

0910-0396 201207-0910-012 0910
             
        "Financial Disclosure by Clinical Investigators"
             
          
        
The collection require sponsors of any drug, biologic or device marketing application to certify to the absence of clinical investigators and/or disclose those financial interests as required, when covered clinical studies are submitted to FDA in support of product marketing. 2015-12-31-05:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 12448 3372 0

Certification--54.4(a)(1) and (a)(2)--Form FDA 3454 No Health Public Health Monitoring
3454 FDA Form 3454 Yes Yes Fillable Fileable Form Form FDA 3454--certification.doc
Individuals or Households 902 902 0

Disclosure--54.4(a)(3)--Form FDA 3455 No Health Public Health Monitoring
3455 FDA Form 3455 Yes Yes Fillable Printable Form Form FDA 3455--disclosure.doc
Individuals or Households 90 450 0

54.4(b)--Clinical Investigators Third Party Disclosure No Health Public Health Monitoring Individuals or Households 10554 1794 0

Recordkeeping--54.6 No Health Public Health Monitoring Individuals or Households 902 226 0

2012-12-20-05:00

0910-0409 201110-0910-003 0910
             
        "Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring "
             
          
        
FDA is requiring approval of regulations which require manufacturers of diagnostic radiopharmaceuticals to submit information that demonstrates the safety and effectiveness of a new diagnostic radiopharmaceutical or of a new indication for use of an approved diagnostic radiopharmaceutical. 2015-02-28-05:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 2 4000 0

Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis nd Monitoring No Health Public Health Monitoring Private Sector 2 4000 0

2012-02-06-05:00

0910-0428 201205-0910-002 0910
             
        "Record Retention Requirements for the Soy Protein/CHD Health Claim"
             
          
        
Section 101.82(c)(2)(ii)(B) of FDA's regulations (21 CFR 101.82(c)(2)(ii)(B)) authorizes use of a health claim about consumption of soy protein and heart disease risk on labels of foods that contain qualifying amounts of soy protein. The regulation requires that manufacturers of food products that bear the health claim and that contain non-soy sources of protein identify and retain records that permit the calculation of the ratio of soy protein to total protein, and provide such records upon written request to appropriate regulatory officials. 2015-06-30-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 25 25 0

Record Retention Requirements for the Soy Protein/CHD Health Claim No Health Consumer Health and Safety Private Sector 25 25 0

2012-06-11-04:00

0910-0429 201207-0910-007 0910
             
        "Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products"
             
          
        
This collection of information describes procedures for requesting, scheduling, conducting, and documenting formal meetings. 2015-12-31-05:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 3864 51416 0

CDER - Meeting Requests No Health Public Health Monitoring Private Sector 2014 20140 0

CBER- Meeting Requests No Health Public Health Monitoring Private Sector 253 2530 0

CDER - Information Packages No Health Public Health Monitoring Private Sector 1394 25092 0

CBER - Information Packages No Health Public Health Monitoring Private Sector 203 3654 0

2012-12-27-05:00

0910-0430 201207-0910-008 0910
             
        "Guidance for Industry on Formal Dispute Resolutions; Appeals Above the Division Level"
             
          
        
This collection of information describes the process for formally reoslving scientific and procedural disputes in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that cannot be resolved at the division level. 2015-12-31-05:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 19 152 0

CDER - Requests for Formal Dispute Resolution No Health Public Health Monitoring Private Sector 18 144 0

CBER - Requests for Formal Dispute Resolution No Health Public Health Monitoring Private Sector 1 8 0

2012-12-27-05:00

0910-0432 201202-0910-004 0910
             
        "Medical Device Recall Authority"
             
          
        
This information collection includes the reporting, recordkeeping, and third-party notification requirements associated with the FDA regulations on medical device recalls. 2015-06-30-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 48 1090 0

Collections Specified in the Order--810.10(d) No Health Consumer Health and Safety Private Sector 2 16 0

Request for Regulatory Hearing--810.11(a) No Health Consumer Health and Safety Private Sector 1 8 0

Written Request for Review--810.12(a-b) No Health Consumer Health and Safety Private Sector 1 8 0

Mandatory Recall Strategy--810.14 No Health Consumer Health and Safety Private Sector 2 32 0

Periodic Status Reports--810.16(a-b) No Health Consumer Health and Safety Private Sector 24 960 0

Termination Request--810.17(a) No Health Consumer Health and Safety Private Sector 2 16 0

Documentation of Notifications to Recipients--810.15(b) No Health Consumer Health and Safety Private Sector 2 8 0

Notification to Recipients--810.15(a)-(c) No Health Consumer Health and Safety Private Sector 2 24 0

Notification to Recipients; Follow-up--810.15(d) No Health Consumer Health and Safety Private Sector 2 8 0

Notification of Consignees by Recipients--810.15(e) No Health Consumer Health and Safety Private Sector 10 10 0

2012-06-12-04:00

0910-0435 201110-0910-002 0910
             
        "Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures"
             
          
        
This collection is intended to achieve the goals and ensure compliance with the regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA) (Pub. L. 100-293). 2015-04-30-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 64805294 2629106 0

203.11 Applications for reimportation to provide emergency care No Health Public Health Monitoring Private Sector 1 1 0

203.30(a)(1) and (b) Drug sample requests No Health Public Health Monitoring Private Sector 743532 44612 0

203.30(a)(3), (a)(4) and (c) Drug Sample Receipts No Health Public Health Monitoring Private Sector 743532 44612 0

203.31(a)(1) and (b) Drug sample requests for samples distributed by means other than mail or a common carrier No Health Public Health Monitoring Private Sector 31367925 1254717 0

203.31(a)(3), (a)(4) and (c) Drug sample receipts for samples distributed by means other than mail or a common carrier No Health Public Health Monitoring Private Sector 31367925 941038 0

203.37(a) Investigation of falsification of records No Health Public Health Monitoring Private Sector 200 50 0

203.37(b) Investigation of significant loss or known theft No Health Public Health Monitoring Private Sector 2000 500 0

203.37(c) Notification of conviction of certain offenses involving drug samples No Health Public Health Monitoring Private Sector 1 1 0

203.37(d) Notification of the individual responsible for RFI No Health Public Health Monitoring Private Sector 50 4 0

203.39(g) Preparation of reconciliation report for donated samples No Health Public Health Monitoring Private Sector 1 1 0

203.23(a) and (b) - Recordkeeping; Credit memo for returned drugs No Health Public Health Monitoring Private Sector 158380 39595 0

203.23(c) - Recordkeeping; Proper storage, handling, and shipping conditions for returned drugs No Health Public Health Monitoring Private Sector 158380 12670 0

203.30(a)(2) and 203.31(a)(2) - Recordkeeping; Verification of Licensing No Health Public Health Monitoring Private Sector 220800 110400 0

203.31(d)(1) and (d)(2) - Recordkeeping; Inventory Record and Reconciliation report No Health Public Health Monitoring Private Sector 2208 88320 0

203.31(d)(4) - Recordkeeping; Discrepancies and Significant Losses No Health Public Health Monitoring Private Sector 442 10608 0

203.31(e) - Recordkeeping; Lists of manufacturers' and distributors' representatives No Health Public Health Monitoring Private Sector 2208 2208 0

203.34 - Recordkeeping; Policies and Procedures for administrative systems No Health Public Health Monitoring Private Sector 90 3600 0

203.37(a) - Recordkeeping;Falsification of Drug Sample records No Health Public Health Monitoring Private Sector 200 1200 0

203.37(b) - Recordkeeping; Report of investigation of significant loss or known theft No Health Public Health Monitoring Private Sector 2000 12000 0

203.39(d) - Recordkeeping; Samples destroyed or returned by charitable institutions No Health Public Health Monitoring Private Sector 65 65 0

203.39(e) - Recordkeeping; Samples donated to charitable institutions No Health Public Health Monitoring Private Sector 3221 1611 0

203.39(f) - Recordkeeping; Donation and distribution or other disposition of donated drug samples No Health Public Health Monitoring Private Sector 3221 25768 0

203.39(g) - Recordkeeping; Inventor and reconciliation of donations to charitable institutions No Health Public Health Monitoring Private Sector 3221 25768 0

203.50(a) - Third Party Disclosure; Drug Origin Statement No Health Public Health Monitoring Private Sector 12500 2125 0

203.50(b) - Recordkeeping; Retention of drug origin statement No Health Public Health Monitoring Private Sector 12500 6250 0

203.50(d) - Recordkeeping; List of authorized distributors No Health Public Health Monitoring Private Sector 691 1382 0

2012-04-09-04:00

0910-0437 201206-0910-003 0910
             
        "Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting"
             
          
        
Section 519(a), (b), and (c) of the Federal Food Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 360i(a), (b), and (c)) requires user facilities, manufacturers, and importers of medical devices to report adverse events involving medical devices to the Food and Drug Administration (FDA). Information from these reports will be used to evaluate risks associated with medical devices and to enable FDA to take appropriate regulatory measures to protect the public health. 2015-08-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 374090 391526 0

Manufacturer Reporting No Health Consumer Health and Safety Private Sector 301077 301077 0

Exemptions No Health Consumer Health and Safety Private Sector 228 684 0

User Facility Reporting No Health Consumer Health and Safety Private Sector 4896 4896 0

User Facility Annual Reporting FDA Form 3419 No Health Consumer Health and Safety
3419 User Facility Annual Report Form Yes No Fillable Fileable Signable Form and instruction User Facility Annual Report Form--FDA 3419.pdf
Private Sector 195 195 0

Importer Reporting, Death and Serious Injury No Health Consumer Health and Safety Private Sector 1 1 0

Supplemental Reports No Health Consumer Health and Safety Private Sector 37448 37448 0

MDR Procedures No Health Consumer Health and Safety Private Sector 220 2200 0

MDR Files No Health Consumer Health and Safety Private Sector 30000 45000 0

Importer Reporting Malfunctions No Health Consumer Health and Safety Private Sector 25 25 0

2012-08-15-04:00

0910-0442 201105-0910-002 0910
             
        "Medical Devices; Device Tracking"
             
          
        
Manufacturers receiving FDA orders to track a device, whose failure would likely have serious adverse health consequences, and which is implanted in humans for more than 1 year, or is life-sustaining or life-supporting and used outside a device user facility, are required to collect/maintain current tracking information about the identity and location of the device during distribution, and about the identity and location of patients receiving the device, including certain physician information. Distributors must report this data to manufacturers. 2014-12-31-05:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 17915 621279 0

Medical Devices; Device Tracking No Health Consumer Health and Safety Private Sector 17915 621279 0

2011-12-12-05:00

0910-0449 201309-0910-003 0910
             
        "Postmarket Surveillance of Medical Devices"
             
          
        
This ICR collects information from manufacturers who are required to conduct postmarket surveillance of a medical device that meets the criteria set forth in the statute. The postmarket surveillance submission includes the postmarket plan, information about the person designated to conduct the surveillance, and organizational/administrative information. The information collection also includes the submission of changes to the plan, requests for a waiver of any requirement of the regulation, requests for exemption from the requirement to conduct postmarket surveillance, and submission of periodic reports as specified in the postmarket surveillance plan. Additionally, manufacturers and investigators must maintain records to ensure that the postmarket surveillance is conducted in accordance with the approved plan. The information collected and maintained enables FDA to ensure that the postmarket surveillance will result in the collection of useful data that can reveal unforeseen adverse events or other information necessary to protect the public health. 2016-10-31-04:00 Active JonnaLynn Capezzuto jonnalynn.capezzuto@fda.hhs.gov 301 827-4659 No No No 1160 37945 0

Postmarket Surveillance of Medical Devices: submissions, changes, waivers, exemption requests, reports No Health Consumer Health and Safety Private Sector 636 33360 0

Recordkeeping Postmarket Surveillance of Medical Devices: manufacturer and investigator records No Health Consumer Health and Safety Private Sector 524 4585 0

2013-10-23-04:00

0910-0454 201309-0910-004 0910
             
        "Guidance for Industry on How to Use E-Mail Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway"
             
          
        
This collection request covers certain electronic submissions with no requirements for a paper copy. These types of documents are listed in public docket 97S-0251 (subsequently changed to FDA-1992-S-0039) as required by 21 CFR 11.2. CVM's guidance entitled "Guidance for Industry: How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway," outlines how to register with CVM's Electronic Submission System (ESS). The likely respondents are sponsors of new animal drug applications who want to submit pre-market information to CVM using the FDA Electronic Submissions Gateway (ESG). 2016-11-30-05:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 156 12 0

Guidance- How to Use E-Mail to Submit Information to CVM in Electronic Format Using The FDA Electronic Submission Gateway No Health Consumer Health and Safety
FDA 3538 Electronic Submission System Participant Management Form Yes Yes Fillable Fileable Signable Form and instruction Form FDA 3538.pdf
Private Sector 156 12 0

2013-11-21-05:00

0910-0456 201211-0910-003 0910
             
        "PHS Guideline on Infectious Disease Issues in Xenotransplantation"
             
          
        
The Public Health Service (PHS) Guideline addresses the public health issues related to xenotransplantation and recommends procedures for diminishing the risk of transmission of infectious agents to the xenotransplantation product recipient, to health care workers, and to the general public. The collection of information described in the PHS Guideline include the notification of certain information to FDA or to the sponsor, and documentation of certain information associated with xenotransplantation. The collection of information is intended to provide general guidance on the following topics: (1) the development of xenotransplantation clinical protocols; (2) the preparation of submissions to FDA; and (3) the conduct of xenotransplantation clinical trials. Also, the collection of information is intended to help ensure that the sponsor maintains important information in a cross-referenced system that links the relevant records of the xenotransplantation product recipient, xenotransplantation product, source animal(s), animal procurement center, and significant nosocomial exposures. 2016-03-31-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 139 47 0

Notify FDA regarding new archive site No Health Health Care Services Private Sector 1 1 0

Establish records regarding xenotransplantation product recipient No Health Health Care Services Private Sector 1 16 0

Maintain medical and research records No Health Health Care Services Private Sector 2 2 0

Document monitoring program results No Health Health Care Services Private Sector 32 8 0

Document necropsy investigations No Health Health Care Services Private Sector 8 2 0

Document justification of quarantine period No Health Health Care Services Private Sector 1 1 0

Document presence/absence of infectious agent No Health Health Care Services Private Sector 1 0 0

Maintain summary of source animal records No Health Health Care Services Private Sector 2 0 0

Document complete necropsy results No Health Health Care Services Private Sector 8 2 0

Maintain archives of Source Animal Medical Records No Health Health Care Services Private Sector 8 1 0

Maintain health care worker monitoring records No Health Health Care Services Private Sector 50 9 0

Maintain health care worker monitoring records No Health Health Care Services Private Sector 1 0 0

Document and maintain health care worker exposure records No Health Health Care Services Private Sector 1 0 0

Document xenotransplant procedures No Health Health Care Services Private Sector 2 1 0

Document location and nature of archived specimens in health care records No Health Health Care Services Private Sector 12 1 0

Notify sponsor regarding new archive site No Health Health Care Services Private Sector 1 1 0

Provide SOPs of source animal facility to appropriate review bodies No Health Health Care Services Private Sector 2 0 0

Provide informed consent document regarding potentially increased infectious risk No Health Health Care Services Private Sector 1 0 0

Provide xenotransplant product recipient records to appropriate review bodies No Health Health Care Services Private Sector 4 2 0

Notify sponsor regarding infectious agent in source animal/herd No Health Health Care Services Private Sector 1 0 0

2013-03-20-04:00

0910-0458 201312-0910-008 0910
             
        "Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations; Form FDA 3486 and Addendum 3486A"
             
          
        
FDA requires certain manufacturers to report all biological product deviations (BPDs) and human cells, tissues, and cellular and tissue based products (HCT/P) deviations in manufacturing for distributed products. The objectives of the BPD reporting and HCT/P deviation reporting requirements are to: (1) Enable FDA to respond when public health may be at risk; (2) expedite reporting of BPD and HCT/P deviations in manufacturing; (3) provide FDA with uniform data to track trends that may indicate broader threats to the public health; (4) create a uniform reporting requirement that can be enforced against non-complying entities; and (5) help ensure that licensed manufacturers and unlicensed blood establishments as well as manufacturers of HCT/Ps are taking appropriate actions to investigate and correct biological product deviations. Reporting of BPDs and HCT/P deviations will also enable FDA to identify areas in which further regulation or guidance is needed to assist licensed manufacturers and unlicensed blood establishments as well as non-reproductive HCT/P establishments in decreasing the occurrence of these events. Form FDA 3486 and 3486A were developed to facilitate FDA's review of the BPD and HCT/P deviation reports. 2017-01-31-05:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 58653 112499 0

Reporting of Biological Product Deviations by Licensed Manufacturers - 600.14 No Health Consumer Health and Safety
3486 Biological Product Deviation Report Yes Yes Fillable Printable Form and instruction FORM FDA-3486 12-5-13.pdf
Private Sector 702 1404 0

Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services - 606.171 No Health Consumer Health and Safety
3486 Biological Product Deviation Report Yes Yes Fillable Printable Form and instruction FORM FDA-3486 12-5-13.pdf
Private Sector 54954 109908 0

Reporting - 1271.350(b) No Health Consumer Health and Safety
3486 Biological Product Deviation Report Yes Yes Fillable Printable Form and instruction FORM FDA-3486 12-5-13.pdf
Private Sector 250 500 0

Form FDA 3486A Addendum No Health Consumer Health and Safety
3486A Biological Product Deviation Report - Addendum Yes Yes Fillable Printable Form and instruction EBPDR_AI_Screen_Shots 12-16-13.doc
Private Sector 2747 687 0

2014-01-27-05:00

0910-0466 201009-0910-005 0910
             
        "Hazard Analysis and Critical Control Point (HACCP) Procedures for the Safe and Sanitary Processing of Juice (21 CFR Part 120)"
             
          
        
FDA`s regulations in part 120(21 CFR part 120) mandate the application of HACCP procedures to fruit and vegetable juice processing. HACCP is a preventive system of hazard control that can be used by all food processors to ensure the safety of their products to consumers. A HACCP system of preventive controls is the most effective and efficient way to ensure that these food products are safe. FDAs mandate to ensure the safety of the nation`s food supply is derived principally from the Federal Food Drug and Cosmetic Act (the act)(21 U.S.C. 321, et seq.). Under the act, FDA has authority to ensure that all foods in interstate commerce, or that have been shipped in interstate commerence, are not misbranded or deceptively packaged; under section 701 (21 u.S.C. 371), the act authorizes the agency to issue regulations for its efficient enforcement. The agency also has authority under section 361 of the Public Health Service Act (42 U.S.C. 264) to issue and enforce regulations to prevent the introduction, transmission, or spread of communicable diseases from one State to another State. 2014-02-28-05:00 Active Denver Presley 3018271462 No No No 21978653 358466 0

Recordkeeping: Sanitation Standard Operating Procedures ( SSOP`s) No Health Consumer Health and Safety Private Sector 684375 68438 0

Recordkeeping : Review of SSOP Records No Health Consumer Health and Safety Private Sector 2530 50600 0

Recordkeeping : Hazard Analysis No Health Consumer Health and Safety Private Sector 21170000 211700 0

Recordkeeping; Hazard Analysis Critical Control Point Plan No Health Consumer Health and Safety Private Sector 22080 2208 0

Recordkeeping: Monitoring Critical Control Points No Health Consumer Health and Safety Private Sector 95680 9568 0

Recordkeeping: Validation of the HACCP Plan No Health Consumer Health and Safety Private Sector 1840 7360 0

Recordkeeping: Application to Imported Products No Health Consumer Health and Safety Private Sector 308 1232 0

Recordkeeping: Verification and Validation of HAACP System and Hazard Analysis No Health Consumer Health and Safety Private Sector 1840 7360 0

2011-01-10-05:00

0910-0470 201010-0910-005 0910
             
        "Special Protocol Assessment Guidance"
             
          
        
The guidance describes agency procedures to evaluate issues related to the adequacy (e.g., design, conduct, analysis) of certain proposed studies. The guidance describes procedures for sponsors to request special protocol assessment and for the agency to act on such requests. 2014-02-28-05:00 Active Eliazabeth Berbakos 3018271482 No No No 510 7244 0

Requests for Special Protocol Assessment No Health Public Health Monitoring Private Sector 452 6780 0

Notification for Carcinogenicity Protocols No Health Public Health Monitoring Private Sector 58 464 0

2011-02-27-05:00

0910-0471 201110-0910-009 0910
             
        "Adverse Event Pilot Program for Medical Devices"
             
          
        
This is an electronic reporting system for hospitals to inform FDA of problems with the use of medical devices. This system involves not only reporting but sharing of information between the participants. 2014-05-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 6000 4500 0

MedSun No Health Consumer Health and Safety
FDA Form 3670 Medsun Submission Yes Yes Fillable Printable Form Form 3670.doc
Private Sector 6000 4500 0

2011-10-31-04:00

0910-0482 201107-0910-004 0910
             
        "Exports:  Notification and Recordkeeping Requirements"
             
          
        
FDA will use the information to determine whether an exporter has complied with the export requirements in the FFDC Act and the PHS Act and, in situations where FDA is required by law to notify an appropriate health official in a foreign country, to determine where a product was exported so that the agency can provide notice to the foreign country. 2014-10-31-04:00 Active Jonnalynn Capezzuto 3018274659 No No No 2160 39120 0

Notification requirements for drugs, biological products, and devices exported under section 802 of the FD&C Act No Health Immunization Management Private Sector 1200 18000 0

Recordkeeping requirements for human drugs, biological products, devices, animal drugs, foods, and cosmetics under or subject to section 801(3)(1) of the FD&C Act and 351(h) of the PHS Act No Health Immunization Management Private Sector 960 21120 0

2011-10-12-04:00

0910-0485 201108-0910-006 0910
             
        "Medical Device Labeling Regulations"
             
          
        
Manufacturers, packers, and distributors of medical devices are required to assure that the labeling of the device includes adequate directions for use according to whether the device is inended for use by health care professionals or lay persons. 2015-02-28-05:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 2432136 3784684 0

Medical Device Labeling Regulations No Health Consumer Health and Safety Private Sector 2432136 3784684 0

2012-02-27-05:00

0910-0491 201206-0910-005 0910
             
        "Emergency Shortages Data Collection System (formerly Emergency Medical Device Shortage Program Survey)"
             
          
        
FDA maintains a medical device database which allows FDA to identify locations and manufacturers of hard to locate medical devices in the context of a Federally-declared disaster/emergency, an official emergency preparedness exercise, or a potential public health risk posed by non-disaster-related device shortage. Because of the dynamic nature of the medical device industry, particularly with respect to specific product lines, manufacturing capabilities and raw material/subcomponent sourcing, it is necessary to update the data in the Emergency Shortages Data Collection System at regular intervals, but efforts are made to limit the frequency of outreach to a specific manufacturer to no more than every 4 months. The Emergency Shortages Data Collection System will only include those medical devices for which there will likely be high demand during a specific emergency/disaster, or for which there are sufficiently small numbers of manufacturers such that disruption of manufacture, or loss of one or more of these manufacturers would create a shortage. 2015-08-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 375 188 0

Emergency Shortages Data Collection System (formerly Emergency Medical Device Shortage Program Survey) No Health Consumer Health and Safety Private Sector 375 188 0

2012-08-15-04:00

0910-0495 201211-0910-009 0910
             
        "Food Additives; Food Contact Substances Notification System"
             
          
        
Food contact substances must be preapproved by FDA for marketing. Manufacturers must provide information, including: (1) the identity and intended use of the food contact substance and (2) the basis for the manufacturer's or supplier's determination that the food contact substance is safe. FDA uses the submitted information to determine whether a food contact substance should be preapproved. 2016-02-29-05:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 237 27035 0

21 CFR 170.106 (Category A) No Health Consumer Health and Safety
FDA 3479 Notification for a Food Contact Substance Formulation Yes Yes Fillable Fileable Form and instruction FDA Form 3479.pdf
Private Sector 5 10 0

21 CFR 170.101 (Category B) No Health Consumer Health and Safety
Yes No Printable Only Instruction Appendix3a -Instructions for Completing Form 3480.pdf FDA 3480 Food Contact Substance Notification Yes Yes Fillable Fileable Form FDA-3480.pdf
Private Sector 5 125 0

21 CFR 170.101 (Category C) No Health Consumer Health and Safety
Yes No Printable Only Instruction Appendix3a -Instructions for Completing Form 3480.pdf FDA 3480 Food Contact Substance Notification Yes Yes Fillable Fileable Form FDA-3480.pdf
Private Sector 10 1200 0

21 CFR 170.101 (Category D) No Health Consumer Health and Safety
Yes No Printable Only Instruction Appendix3a -Instructions for Completing Form 3480.pdf FDA 3480 Food Contact Substance Notification Yes Yes Fillable Fileable Form FDA-3480.pdf
Private Sector 66 9900 0

21 CFR 170.101 (Category E) No Health Consumer Health and Safety
Yes No Printable Only Instruction Appendix3a -Instructions for Completing Form 3480.pdf FDA 3480 Food Contact Substance Notification Yes Yes Fillable Fileable Form FDA-3480.pdf
Private Sector 30 4500 0

21 CFR 170.1 Indirect Food Additives No Health Consumer Health and Safety Private Sector 1 10995 0

Use of Recycled Plastics in Food Packaging No Health Consumer Health and Safety Private Sector 10 250 0

Prenotification Consultation or Master File (concerning a food contact substance) No Health Consumer Health and Safety
Yes No Printable Only Instruction Appendix3a -Instructions for Completing Form 3480.pdf FDA 3480 Food Contact Substance Notification Yes Yes Fillable Fileable Form FDA-3480.pdf
Private Sector 60 30 0

Amendment to existing notification, prenotification consultation, or Master File (concerning a food contact substance) No Health Consumer Health and Safety
FDA 3480A Amendment to Existing Food Contact Notification Prenotification Consultation Food Master File Yes Yes Fillable Fileable Form FDA3480A.pdf Yes No Printable Only Instruction Appendix3b -Instructions for Completing Form 3480A.pdf
Private Sector 50 25 0

2013-02-13-05:00

0910-0497 201103-0910-003 0910
             
        "Focus Groups as Used by the Food and Drug Administration"
             
          
        
The Food and Drug Administration (FDA) is requesting approval for collecting information through the use of focus groups for studies involving all products regulated by FDA. This information will be used as a first step to explore concepts of interest and assist in the development of quantitative study proposals, complementing other important research efforts in the agency. This information may also be used to help develop communication messages and campaigns. Focus groups play an important role in gathering information because they allow for an in-depth understanding of individuals' attitudes, beliefs, motivations, and feelings. Focus group research serves the narrowly defined need for direct and informal public opinion on a specific topic. 2014-06-30-04:00 Active Jonnalynn Capezzuto 3018274659 No No No 1440 2520 0

Consumer Risk Perceptions of Tobacco Products (Initial Focus Group Study) No Health Immunization Management Individuals or Households 192 307 0

Consumer perceptions as a foundation for CTP positioning initiative No Health Immunization Management Individuals or Households 64 128 0

Claims about "Natural" No Health Consumer Health and Safety Individuals or Households 96 202 0

Conducting Focus Groups & In Depth Interviews to Understand and Differentiate the Impact of REMS/ETASU on Prescriber Practices No Health Illness Prevention Individuals or Households 108 216 0

Risk and Benefit Perception Scale Development Focus Groups No Health Public Health Monitoring Individuals or Households 360 189 0

FDA/CTP Consumer Risk Perceptions of Tobacco Products: 2nd Focus Group Study No Health Immunization Management Individuals or Households 192 211 0

Establishment of a Tobacco User Panel: Focus Group Study No Health Immunization Management Individuals or Households 45 68 0

Other Tobacco Products (OTP); A Focus Group Study - Cigar, etc. No Health Immunization Management Individuals or Households 480 528 0

2011-06-27-04:00

0910-0498 201305-0910-001 0910
             
        "Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802"
             
          
        
Section 801(e)(4) of the act provides that persons exporting certain FDA-regulated products may request FDA to certify that the products meet the requirements of Sections 801(e) or 802 of the FD&C Act, or other requirements of the act. This section of the law requires FDA to issue export certificates within 20 days of receipt of the request and to charge firms up to $175 for the certificates. 2015-03-31-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 78343 50942 3107462

CBER Export Certificate (FDA 3613, 3613b, 3613c) No Health Immunization Management
FDA 3613b Supplementary Information Certificate of a Pharmaceutical Product Yes Yes Fillable Fileable Form and instruction FDA-3613b.pdf FDA 3613c Supplementary Information Non-Clinical Research Use Only Certificate Yes Yes Fillable Fileable Form and instruction FDA-3613c.pdf FDA 3613 Supplementary Information Certificate to Foreign Government Requests Yes Yes Fillable Fileable Form and instruction FDA-3613.pdf
Private Sector 2114 2114 0

CDER Export Certificate (FDA 3613b) No Health Consumer Health and Safety
FDA 3613b Supplementary Information Certificate of a Pharmaceutical Product Yes Yes Fillable Fileable Form and instruction FDA-3613b.pdf
Private Sector 5251 10502 0

CDRH Export Certificate (FDA 3613, 3613a, 3613c) No Health Consumer Health and Safety
FDA 3613a Supplementary Information Certificate of Exportability Requests Yes Yes Fillable Fileable Form and instruction FDA-3613a.pdf FDA 3613c Supplementary Information Non-Clinical Research Use Only Certificate Yes Yes Fillable Fileable Form and instruction FDA-3613c.pdf FDA 3613 Supplementary Information Certificate to Foreign Government Requests Yes Yes Fillable Fileable Form and instruction FDA-3613.pdf
Private Sector 6463 12926 0

CVM Export Certificate (FDA 3613, 3613b) No Health Consumer Health and Safety
FDA 3613b Supplementary Information Certificate of a Pharmaceutical Product Yes Yes Fillable Fileable Form and instruction FDA-3613b.pdf FDA 3613 Supplementary Information Certificate to Foreign Government Requests Yes Yes Fillable Fileable Form and instruction FDA-3613.pdf
Private Sector 855 855 0

CFSAN Export Certificate-Office of Nutrition, Labeling and Supplements (FDA 3613e) No Health Consumer Health and Safety
FDA 3613e Food Export Certificate Application Yes Yes Fillable Fileable Signable Form and instruction 3613e_updated.pdf
Private Sector 772 1158 0

CFSAN Export Certificate-Office of Cosmetics and Colors (FDA 3613d) No Health Consumer Health and Safety
FDA 3613d Office of Cosmetics and Colors "Certificate" (Exports) Application Yes Yes Fillable Fileable Signable Form and instruction 3613d_updated.pdf
Private Sector 11609 23218 0

CFSAN Export Certificate-Office of Food Safety (FDA3613e) No Health Consumer Health and Safety
FDA 3613e Food Export Certificate Application Yes Yes Fillable Fileable Signable Form and instruction 3613e_updated.pdf
Private Sector 337 169 0

Costs of Certificates No Health Consumer Health and Safety
FDA 3613e Food Export Certificate Application Yes Yes Fillable Fileable Signable Form and instruction 3613e_updated.pdf
Private Sector 50942 0 3107462

2013-05-20-04:00

0910-0500 201012-0910-003 0910
             
        "Generic FDA Rapid Response Surveys"
             
          
        
This program will obtain data on safety information to support quick-turnaround decision-making about potential safety problems or risk management solutions. This information will be collected from health professionals, hospitals, and other user facilities (e.g., nursing homes, ambulatory surgical facilities and outpatient diagnostic and treatment facilities, etc.), consumers, sponsors and manufacturers of biologics, drugs and medical products, distributors, and importers when FDA must quickly determine whether or not a problem with a medical product impacts the public health. 2014-06-30-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 60000 30000 0

FDA's Center for Tobacco Products State Department of Health Electronic Cigarette Adverse Event Survey No Health Public Health Monitoring State, Local, and Tribal Governments 50 800 0

Rapid Response Survey -- Middle East Respiratory Syndrome-Coronavirus (MERS-CoV) No Health Consumer Health and Safety Individuals or Households 5500 458 0

2011-06-13-04:00

0910-0502 201305-0910-006 0910
             
        "Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002"
             
          
        
This collection requires manufacturers, processors, holders, and distributers of foods to provide registration information to the agency including name,location, contact information, etc. Through this registration program and the information provided under the regulations the agency is able to identify firms in the event of food-related emergencies as well as ensure that contaminated food producsts are quickly and efficiently removed from the marketplace. 2016-08-31-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 380830 468117 0

21 CFR 1.230-1.233 - Reporting Domestic New Facilities : Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 No Health Consumer Health and Safety
FDA 3537 Food Facility Registration Yes Yes Fillable Fileable Form and instruction FDA Form 3537.pdf
Private Sector 11080 29916 0

21 CFR 1.230-1.233 - Reporting Foreign New Facilities: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparadness and Response Act of 2002 No Health Consumer Health and Safety
FDA 3537 Food Facility Registration Yes Yes Fillable Fileable Form and instruction FDA Form 3537.pdf
Private Sector 19900 177110 0

21 CFR 1.234 Reporting: Requirement for Previously Registered Facilities to Submit Timely Updates Within 60 Days Of A Change to Any Required Item of Registration Information No Health Consumer Health and Safety
FDA 3537 Food Facility Registration Yes Yes Fillable Fileable Form and instruction FDA Form 3537.pdf
Private Sector 118530 142236 0

21 CFR 1.235 Reporting; Requires the Registration For a Previously Registered Facility to Be Cancelled When The Facility Ceases to Operate ... . No Health Consumer Health and Safety
FDA 3537a Cancellation of Food Facility Registration Yes Yes Fillable Fileable Form and instruction FDA Form 3537a.pdf
Private Sector 6390 6390 0

Domestic Registration Additional Data Required by FSMA No Health Consumer Health and Safety
FDA Form 3537 Food Facility Registration Yes Yes Fillable Fileable Form 0910 0502 FFRM screen shots.pdf
Private Sector 0 0 0

Foreign New Facility Registration New Data Required by FSMA No Health Consumer Health and Safety Private Sector 0 0 0

Biennial Renewal of Registration Additional Data Required by FSMA No Health Consumer Health and Safety
FDA 3537 Food Facility Registration Yes Yes Fillable Fileable Form and instruction FDA Form 3537.pdf
Private Sector 224930 112465 0

Occasional Facility Update Additional Data Required by FSMA No Health Consumer Health and Safety Private Sector 0 0 0

2013-08-06-04:00

0910-0508 201301-0910-010 0910
             
        "FY 2012 MDUFMA Small Business Qualification Certification (Form FDA 3602)"
             
          
        
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) requires FDA to collect a user fee from each person who submits certain medical device applications for FDA review. A "small business" is eligible for reduced or waived fees; small business fees for FY 2010. If an applicant does not provide information to FDA demonstrating to FDA's satisfaction that the applicant is a small business, the applicant must pay the standard (full) fee for any application it submits. 2016-03-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 5100 5100 0

FY 2012 MDUFMA Small Business Qualification Certification (Form FDA 3602) No Health Consumer Health and Safety
3602 Medical Device User Fee Yes Yes Fillable Printable Form and instruction Guidance form 3602.pdf
Private Sector 5100 5100 0

2013-03-20-04:00

0910-0509 201310-0910-004 0910
             
        "Establishing a List of U.S. Dairy Producers for Export to Chile"
             
          
        
This ICR supports an agency program by which respondents may be included on an established list of U.S. dairy firms who wish to export to foreign countries. Respondents who wish to be included on the list will voluntarily send information to FDA, including the name and address of the firm and the manufacturing plant, a list of products presently shipped and expected to be shipped in the future, and identities of agencies that inspect the plant, plant number and copy of last inspection. 2014-05-31-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 163 176 0

New Written Request to be Placed on the List of U.S. Dairy Producers for Export No Health Consumer Health and Safety Private Sector 50 75 0

Biennial Update of Infomation by Firms Already on the List of U.S. Dairy Producers For Export No Health Consumer Health and Safety Private Sector 88 88 0

Occasional Update of Information by Firms on the List of U.S. Dairy Producers for Export No Health Consumer Health and Safety Private Sector 25 13 0

2013-11-07-05:00

0910-0510 201301-0910-011 0910
             
        "Medical Devices; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA)"
             
          
        
Information from this collection will be used by FDA to implement an Inspection by Accredited Persons program that will train and accredit persons that wish to conduct inspections of eligible manufacturers of class II and class III medical devices. This action is required by MDUFMA. 2016-04-30-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 1 80 0

Medical Devices; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) No Health Consumer Health and Safety Private Sector 1 80 0

2013-04-10-04:00

0910-0511 201302-0910-003 0910
             
        "Medical Device User Fee Cover Sheet - FDA Form 3601"
             
          
        
The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250), and the Medical Device User Fee Amendments of 2007 (Title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to collect user fees for certain medical device applications. Under this authority, companies pay a fee for certain new medical device applications or supplements submitted to the agency for review. Because the submission of user fees concurrently with applications and supplements is required, the review of an application cannot begin until the fee is submitted. Form FDA 3601, the "Medical Device User Fee Cover Sheet", is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to account for and track user fees. Form FDA 3601 and instructions are available online for registered users. A pdf of the form has been attached with this ICR. 2016-04-30-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 5214 1564 0

Medical Device User Fee Cover Sheet - FDA Form 3601 No Health Consumer Health and Safety
3601 Medical Device User Fee Cover Sheet http://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFeeandModernizationAct/ucm155274.htm Yes Yes Fillable Fileable Signable Form MDUFA cover sheet.pdf http://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFeeandModernizationAct/ucm155274.htm Yes Yes Printable Only Instruction Medical Device MDUFMA User Fees Cover sheet instructions.pdf
Private Sector 5214 1564 0

2013-04-10-04:00

0910-0513 201309-0910-011 0910
             
        "Applications for FDA Approval to Market a New Drug:  Patient Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That..."
             
          
        
Section 314.50(h) requires that an NDA, an amendment, or a supplement contain patent information described under Section 314.53. Section 314.53 requires that an pplicant submitting an NDA, an amendment, or a supplement submit on Forms 3542 and 3542a the required patent information. If a patent is issued after the application is filed with FDA but before the application is approved, the applicant must submit the reuqired patent information on Form 3542a as an amendment to the application, within 30 days of the date of issuance of the patent. Within 30 days after the date of approval of an application, the applicant must submit Form 3542 for each patent that claims the drug substance (active ingredient), drug product (formulation and composition), or approved method of use for listing in the Orange Book. In addition, for patents issued after the date of approval of an application, Form 3542 must be submitted within 30 days of the date of issuance of the patent. 2016-10-31-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 1075 13820 0

Form FDA 3542 No Health Consumer Health and Safety
3542 Patent Information Submitted Upon and After Approval of an NDA or Supplement Yes No Printable Only Form FORM FDA 3542.pdf
Private Sector 512 2560 0

Form FDA 3542a No Health Consumer Health and Safety
35421 Patent Information Submitted With the Filing of an NDA, Amendment, or Supplement Yes No Printable Only Form FORM FDA 3542a.pdf
Private Sector 563 11260 0

2013-10-23-04:00

0910-0520 201005-0910-017 0910
             
        "Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002"
             
          
        
Section 801(m) of the Federal Food Drug and Cosmetic Act(the act) (21 U.S.C.381(m) requires that FDA receive prior notice for food, including food for animals, that is imported or offered for import into the United States. Sections 1.278 to 1.282 of FDAs regulations ( 21 CFR 1.278 to 1.282) set forth the requirements for submitting prior notice; sections 1.283 (d) and 1.285 (j)set forth the procedure for requesting FDA review after an article of food has been refused admission under section 801 ( m )(1) of the act or placed under hold under section 801 (l) of the act; and section 1.285 (i) ( 21 CFR 1.285 ( i) sets forth the procedure for post- hold submissions. Advance notice of imported food allows FDA, with support of the Bureau of Customs and Border Protection ( CBP), to target import inspections more effectively and help protect the nations` food supply against terrorist acts and other public health emergencies. 2014-02-28-05:00 Active Jonnalynn Capezzuto 3018274659 No No No 10038502 1859474 0

21 CFR 1.280, 1.281- Reporting: New Prior Notice Submisions Submitted Through The ABI/ACS System. Regulation Sets Forth Information That the Prior Notice Is Required to Contain No Health Consumer Health and Safety Private Sector 8385000 1257750 0

21 CFR 1.280,1.281 - Reporting: New Prior Notice Submission Submitted Through The PN System Interface. Regulation Sets Forth Information That The Prior Notice Is Required to Contain No Health Consumer Health and Safety
3540 Prior Notice Submission http://www.access.fda.gov/ No No Fillable Fileable Signable Form US FDA Industry Systems 3540 Screenshot.htm
Private Sector 1569500 580715 0

21 CFR 1.282 Reporting; Prior Notice Cancellation Through the ABI/ACS System. Regulation Sets Forth Cancellation Requirements & Information That Prior Notice Is Required to Contain. No Health Consumer Health and Safety
3540 Prior Notice Submission http://www.access.fda.gov/ No No Fillable Fileable Signable Form US FDA Industry Systems 3540 Screenshot.htm
Private Sector 19500 4875 0

21 CFR 1.282, 1.283(a)(5)- Reporting: Prior Notice Cancellation Through The PN Systen Interface. Regulation Sets Forth Cancellation Requirements & Information That the Prior Notice ... . No Health Consumer Health and Safety
3540 Prior Notice Submission http://www.access.fda.gov/ No No Fillable Fileable Signable Form US FDA Industry Systems 3540 Screenshot.htm
Private Sector 64500 16125 0

21 CFR 1.283 (d);1.285(i);1.285(j) - Reporting: Prior Notice Requests for Review & Post - Hold Submissions Under 801 (m)(1) of The Federal Food, Drug & Cosmetic Act. No Health Consumer Health and Safety Private Sector 1 8 0

21 CFR 1.285 ( i) - Reporting: Prior Notice Requests For Review & Post - Hold Submissions Under 801 ( l ) of The Federal Food Drug & Cosmetic Act. No Health Consumer Health and Safety Private Sector 1 1 0

2010-12-01-05:00

0910-0523 201308-0910-004 0910
             
        "Product Jurisdiction:  Assignment of Agency Component for Review of Premarket Applications"
             
          
        
This regulation provides the procedure by which an applicant may obtain an assignment or designation determination for combination products. 2016-09-30-04:00 Active JonnaLynn Capezzuto jonnalynn.capezzuto@fda.hhs.gov 301 827-4659 No No No 59 1416 0

Request for designation No Health Consumer Health and Safety Private Sector 59 1416 0

2013-09-20-04:00

0910-0530 201309-0910-009 0910
             
        "Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format"
             
          
        
The content of labeling is required to be submitted electronically for review with NDAs, certain BLAs, ANDAs, supplements, and annual reports. FDA's review of labeling is an integral part of its approval of marketing application for drugs and biologics. The labeling must be consistent with the approved conditions for marketing. 2016-10-31-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 5750 7188 0

Content of Labeling Submissions in NDAs, ANDAs, Supplemental NDAs and ANDAs, and Annual Reports No Health Consumer Health and Safety Private Sector 5750 7188 0

2013-10-23-04:00

0910-0537 201306-0910-001 0910
             
        "Bar Code Label Requirements for Human Drug Products and Biological Products"
             
          
        
FDA regulations at 21 CFR 201.25 requires bar codes on the labels of most human prescription drug products and on certain OTC drug products. Most of the information collection resulting from this regulation is covered under existing OMB control numbers. This ICR only requests OMB approval for waiver requests from the bar code requirement. A request that FDA waive the bar code requirement for a particular drug product must include the following information: (1) Compliance with the bar code requirement would adversely affect the safety, effectiveness, purity, or potency of the drug or not be technologically feasible, and the concerns underlying the request could not reasonably be addressed by measures such as package redesign or use of overwraps; or (2) an alternative regulatory program or method of product use renders the bar code unnecessary for patient safety. 2016-08-31-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 2 48 0

Bar Code Label Requirements - 21 CFR 201.25(d) No Health Public Health Monitoring Private Sector 2 48 0

2013-08-06-04:00

0910-0539 201102-0910-010 0910
             
        "Animal Drug User Fee Cover Sheet"
             
          
        
An animal drug application or supplemental animal drug application submitted by a person subject to application fees is considered incomplete and will not be accepted for filing by FDA until all fees owed by such person have been paid. Section 740(e) of the FD&C Act. ADUFA requires the submisssion of the User Fees concurrently with applications. If the required fees are not submitted, the review of the application will not begin. The User Fee Cover Sheet provides the information necessary to either initiate or defer the application review. 2014-04-30-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 76 76 0

Animal Drug User Fee Cover Sheet No Health Consumer Health and Safety
3546 Animal Drug User Fee Cover Sheet Yes Yes Fillable Printable Form and instruction 0910-0539 Form 3546.pdf
Private Sector 76 76 0

2011-04-25-04:00

0910-0540 201102-0910-002 0910
             
        "Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions"
             
          
        
An animal drug application or supplemental animal drug application submitted by a person subject to application fees is considered incomplete and will not be accepted for filing by FDA until all fees owed by such person have been paid. Section 740(e) of the FD&C Act. The purpose of collecting this information is to provide persons subject to fees an opportunity to obtain a waiver or reduction of certain animal drug user fees in advance of the submissin of certain applications or in advance of the invoicing of the other annual fees. 2014-05-31-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 83 166 0

Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions No Health Consumer Health and Safety Private Sector 83 166 0

2011-05-02-04:00

0910-0541 201009-0910-007 0910
             
        "Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition"
             
          
        
As an integral part of its decision making process, the Food and Drug Administration (FDA) is obligated under the National Environmental Policy Act of 1969 (NEPA) to consider the environmental impact of its actions, including allowing notifications for food contact substances to become effective and approving food additive petitions, color additive petitions, GRAS affirmation petitions, requests for exemption from regulation as a food additive, and actions on certain food labeling citizen petitions, nutrient content claims petitions, and health claims petitions. In 1997, FDA amended its regulations in part 25 (21 CFR part 25) to provide for categorical exclusions for additional classes of actions that do not individually or cumulatively have a significant effect on the human environment (62 FR 40570, July 29, 1997). As a result of that rulemaking, FDA no longer routinely requires submission of information about the manufacturing and production of FDA-regulated articles. FDA also has eliminated the previously required Environmental Assessment (EA) and abbreviated EA formats from the amended regulations. Instead, FDA has provided guidance that contains sample formats to help industry submit a claim of categorical exclusion or an EA to the Center for Food Safety and Applied Nutrition (CFSAN). The guidance document entitled, Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition identifies, interprets, and clarifies existing requirements imposed by statute and regulation, consistent with the Council on Environmental Quality regulations (40 CFR 1507.3). It consists of recommendations that do not themselves create requirements; rather, they are explanatory guidance for FDAs own procedures in order to ensure full compliance with the purposes and provisions of NEPA. 2014-02-28-05:00 Active Denver Presley 3018271462 No No No 37 37 0

Reporting: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition No Health Consumer Health and Safety Private Sector 34 34 0

Reporting: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition No Health Consumer Health and Safety Private Sector 1 1 0

Reporting: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition No Health Consumer Health and Safety Private Sector 2 2 0

2010-12-05-05:00

0910-0543 201008-0910-004 0910
             
        "Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)"
             
          
        
Under section 361 of the Public Health Service Act (the PHS Act)(42 U.S.C. 264), FDA may issue and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases between the States or possessions or from foreign countries into the States. As derivatives of the human body, all HCT/Ps pose some risk of carrying pathogens that could potentially infect recipients or handlers. FDA has issued regulations related to HCT/Ps involving establishment registration and listing using Form FDA 3356; eligibility determination for donors; and current good tissue practice (CGTP). Form FDA 3356: Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products is used to submit the required information (1271.10, 1271.21, 1271.25, and 1271.26). 2014-02-28-05:00 Active Eliazabeth Berbakos 3018271482 No No No 9174735 3923214 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Public Health Monitoring Private Sector 2026024 1906448 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

New SOPs No Health Consumer Health and Safety Private Sector 251 12048 0

SOP Update No Health Consumer Health and Safety Private Sector 2281 54744 0

21 CFR 1271 No Health Consumer Health and Safety Private Sector 7146179 1949974 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice No Health Consumer Health and Safety Private Sector 0 0 0

2011-01-31-05:00

0910-0545 201105-0910-008 0910
             
        "Health and Diet Survey"
             
          
        
The Health and Diet Survey is a voluntary consumer survey intended to gauge and track consumer attitudes, awareness, knowledge, and behavior regarding various topics related to health, nutrition and physical activity. The authority for FDA to collect the information derives from the FDA Commissioner's authority provided in section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)). FDA and other Federal agencies will use the information from the Health and Diet Survey to evaluate and develop strategies and programs to encourage and help consumers adopt healthy lifestyles. The information will also help the FDA and other Federal agencies evaluate and track consumer awareness and behavior as outcome measures of their achievement in improving public health. 2014-09-30-04:00 Active Denver Presley 3018271462 No No No 18227 1301 0

Health and Diet Survey - General Topics: Pretest No Health Consumer Health and Safety Individuals or Households 27 7 0

Health and Diet Survey-General Topics : Screener No Health Consumer Health and Safety Individuals or Households 10000 200 0

Health and Diet Survey- General Topics : Survey No Health Consumer Health and Safety Individuals or Households 3000 750 0

Health and Diet Survey - Dietary Guidelines Supplement : Screener No Health Consumer Health and Safety Individuals or Households 4000 80 0

Health and Diet Survey - Dietary Guidlines : Survey No Health Consumer Health and Safety Individuals or Households 1200 264 0

Health and Diet Survey No Health Consumer Health and Safety Individuals or Households 0 0 0

2011-09-05-04:00

0910-0546 201304-0910-002 0910
             
        "Food Additive Petitions, 21 CFR Part 571, Center for Veterinary Medicine"
             
          
        
A food additive shall be deemed to be unsafe unless its use is permitted by a regulation which prescribes the condition(s) under which it may safely be used, or unless it is exempted by regulation for investigational use. Therefore, certain information must be submitted by a petition in order to establish the safety of a food additive and to secure the issuance of a regulation permitting its use in animal food. 2016-05-31-04:00 Active JonnaLynn Capezzuto jonnalynn.capezzuto@fda.hhs.gov 301 827-4659 No No No 19 51700 0

Moderate Category - Non-complex Food Additive Petitions No Health Consumer Health and Safety Private Sector 1 3000 0

Complex Category- Complex Food Additive Petitions No Health Consumer Health and Safety Private Sector 1 10000 0

Amendment of Petitions No Health Consumer Health and Safety Private Sector 4 5200 0

Moderate category - Investigational Food Additive Files No Health Consumer Health and Safety Private Sector 9 13500 0

Complex category - Investigational Food Additive Files No Health Consumer Health and Safety Private Sector 4 20000 0

2013-05-23-04:00

0910-0551 201102-0910-008 0910
             
        "Application for Participation in the Medical Device Fellowship Program; Form FDA 3608"
             
          
        
The purpose of this collection is to develop a pool of qualified external scientific experts and to increase the range and depth of collaborations between CDRH and the outside scientific community. The information will be collected electronically and via U.S. mail and will be used to recruit qualified experts. 2014-03-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 250 250 0

Application for Participation in the Medical Device Fellowship Program; Form FDA 3608 No Health Consumer Health and Safety
FDA 3608 CDRH Medical Device Fellowship Program http://www.fda.gov/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/MedicalDeviceFellowshipProgramCDRH/ucm136172.htm Yes Yes Fillable Printable Form Medical Device Fellowship Program (EEP, OCD, CDRH) CDRH Medical Device Fellowship Program - Application Form.htm
Individuals or Households 250 250 0

2011-03-28-04:00

0910-0553 201101-0910-003 0910
             
        "Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use"
             
          
        
The purpose of this guidance is to allow the use of selected symbols in place of text. This guidance helps IVD manufacturers to create uniform labels and labeling for the United States and European Union (and any other countries that may permit use of symbols from these international standards)instead of needing designated labels for each market place. 2014-03-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 689 2756 0

Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use No Health Consumer Health and Safety Private Sector 689 2756 0

2011-03-21-04:00

0910-0557 201102-0910-006 0910
             
        "Guidance for Industry - Pharmacogenomic Data Submissions"
             
          
        
This information collection request covers the data collection recommended by FDA in 2005 guidance regarding what pharmacogenomic data should be submitted to FDA by sponsors submitting or holding investigational new drug applications (INDs), new drug applications (NDAs), or biologics license applications (BLAs) during the drug development process. 2014-05-31-04:00 Active Eliazabeth Berbakos 3018271482 No No No 7 350 0

Guidance for Industry - Pharmacogenomic Data Submissions No Health Public Health Monitoring Private Sector 7 350 0

2011-05-19-04:00

0910-0560 201103-0910-013 0910
             
        "Recordkeeping and Records Access Requirements for Food Facilities"
             
          
        
The Bioterrorism Act requires the Secretary, through FDA to develop regulations requiring the establishment and maintenance of records by persons (domestic and foreign) manufacturer, process, pack, transport, distribute, receive, hold or import food or food packaging. 2014-06-30-04:00 Active Denver Presley 3018271462 No No No 398468 5110890 0

Recordkeeping : Establishment and Maintenance of Records Under the B. T. Act of 2002 No Health Consumer Health and Safety Private Sector 379493 5020000 0

Recordkeeping : New Firms-Learning of Regulatory Requirements and Understanding of Records for Compliance with the B.T. Act of 2002 No Health Consumer Health and Safety Private Sector 18975 90890 0

2011-06-27-04:00

0910-0562 201107-0910-006 0910
             
        "Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have Been Revoked, Suspended, or Modified by the EPA"
             
          
        
FDA's guidance, "Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations," represents the agency's current thinking on its planned enforcement approach to the channels of trade provision of the Federal Food, Drug, and Cosmetic Act and how that provision relates to FDA-regulated products with residues of pesticide chemicals for which tolerances have been revoked, suspended, or modified by EPA pursuant to dietary risk considerations. FDA anticipates that food bearing lawfully applied residues of pesticide chemicals that are the subject of future EPA action to revoke, suspend, or modify their tolerances, will remain in the channels of trade after the applicable tolerance is revoked, suspended, or modified. If FDA encounters food bearing a residue of a pesticide chemical for which the tolerance has been revoked, suspended, or modified, it intends to address the situation in accordance with provisions of the guidance. In general, FDA anticipates that the party responsible for food found to contain pesticide chemical residues (within the former tolerance) after the tolerance for the pesticide chemical has been revoked, suspended, or modified will be able to demonstrate that such food was handled, e.g., packed or processed, during the acceptable timeframes cited in the guidance by providing appropriate documentation to the agency as discussed in the guidance document. Examples of documentation which FDA anticipates will serve this purpose consist of documentation associated with packing codes, batch records, and inventory records. These are types of documents that many food processors routinely generate as part of their basic food-production operations. 2014-09-30-04:00 Active Denver Presley 3018271462 No No No 2 19 0

Reporting/Documentation Submission - Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have Been Revoked, Suspended, or Modified by the EPA No Health Consumer Health and Safety Private Sector 1 3 0

Recordkeeping/Documentation - Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have Been Revoked, Suspended, or Modified by the EPA No Health Consumer Health and Safety Private Sector 1 16 0

2011-09-27-04:00

0910-0563 201109-0910-001 0910
             
        "Guidance for Industry:  Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice"
             
          
        
This information collection allows agencies to request dispute resolution and describes the type of information that should accompany these requests. The dispute resolution process focuses on FDA's current CGMP program and covers the manufacture of veterinary and human drugs, including human biological drug products. 2015-02-28-05:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 2 68 0

Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice No Health Public Health Monitoring Private Sector 2 68 0

2012-02-27-05:00

0910-0566 201110-0910-005 0910
             
        "Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the CVM"
             
          
        
This guidance document describes the CVM policy for resolution of disputes relating to scientific controversies. A scientific controversy involves issues that arise within the context of the Center's regulation of a specific product and are related to matters of technical expertise that require some specialize education, training or experience to be understood and resolved. The guidance document describes the dispute resolution procedures that we recommend be followed by sponsors, applicants, and manufacturers when requesting review of FDA decisions relating to regulated products for animals. 2015-02-28-05:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 3 30 0

Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the CVM No Health Consumer Health and Safety Private Sector 3 30 0

2012-02-06-05:00

0910-0569 201109-0910-004 0910
             
        "Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program"
             
          
        
Under Section 201 of the Medical Device User Fee and Modernization Act of 2002, a medical device manufacturer may use an accredited person (AP) to perform an inspection of their facility that would otherwise be performed by FDA. The manufacturer must first submit a request to FDA to obtain approval to use an AP. 2015-02-28-05:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 15 1500 0

Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program No Health Consumer Health and Safety Private Sector 15 1500 0

2012-02-06-05:00

0910-0572 201204-0910-001 0910
             
        "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products"
             
          
        
FDA regulations governing the format and content of labeling for human prescription drug and biological products requiring that the labeling of new and recently approved products contain highlights of prescribing information, a table of contents for prescribing information, reordering of certain sections, minor content changes, and minimum graphical requirements. 2015-08-31-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 105 351645 0

Annual Burden for Labeling Requirement in 201.56 and 201.57 No Health Public Health Monitoring Private Sector 105 351645 0

Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule No Health Public Health Monitoring Private Sector 0 0 0

Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule No Health Public Health Monitoring Private Sector 0 0 0

Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule No Health Public Health Monitoring Private Sector 0 0 0

2012-08-15-04:00

0910-0575 201203-0910-004 0910
             
        "Waivers of Invivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type a Medicated Articles"
             
          
        
This guidance describes the procedures that the Agency recommends for the review of requests for waiver of invivo demonstration of bioequivalence for generic soluble powder oral dosage form products and Type A Medicated Articles. The respondents are animal drug manufacturers. 2015-06-30-04:00 Active Denver Presley 3018271462 No No No 36 530 0

Waivers of Invivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type a Medicated Articles No Health Consumer Health and Safety Private Sector 36 530 0

2012-06-12-04:00

0910-0577 201202-0910-003 0910
             
        "Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices"
             
          
        
This information collection covers the third-party disclosures associated with section 502 (21 U.S.C. 352) of the Federal Food, Drug, and Cosmetic Act, which, among other things, establishes requirements that the label or labeling of a medical device must meet so that it is not misbranded and subject to regulatory action. 2015-05-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 404 40 0

Establishments listing less than 10 SUDs No Health Public Health Monitoring Private Sector 94 9 0

Establishments listing 10 or more SUDs No Health Public Health Monitoring Private Sector 310 31 0

2012-05-11-04:00

0910-0581 201204-0910-002 0910
             
        "Guidance for Industry: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees"
             
          
        
The purpose of this collection is to provide the data monitoring committees with information regarding clinical trials. The collection of information includes the following reporting, recordkeeping, and third-party provisions for sponsors and data monitoring committees: (1) Sponsor reporting to FDA on DMC recommendations related to safety; (2) standard operating procedures (SOPs) for DMCs; (3) DMC meeting records; (4) sponsor notification to the DMC regarding waivers; and (5) DMC reports based on meeting minutes to the sponsor. 2015-10-31-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 1185 1795 0

Sponsor reporting to FDA on DMC recommendations No Health Consumer Health and Safety Private Sector 37 19 0

SOPs for DMCs No Health Health Care Services Private Sector 37 296 0

DMC Meeting Records No Health Health Care Services Private Sector 370 740 0

Sponsor notification to the DMC regarding waivers No Health Health Care Services Private Sector 1 0 0

DMC reports of meeting minutes to the sponsor No Health Health Care Services Private Sector 740 740 0

2012-10-02-04:00

0910-0582 201302-0910-004 0910
             
        "Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable"
             
          
        
The FDA has developed a guidance document that will inform sponsors, institutional review boards (IRBs), clinical investigators, and agency staff that the FDA intends to exercise enforcement discretion, under certain circumstances, with respect to its informed consent regulations under 21 CFR 812.2 (c) (3), for in vitro diagnostic device studies that are conducted using leftover specimens. This guidance responds to an immediate need of the research community. Sponsors that follow this guidance should maintain written documentation demonstrating that they meet the circumstances outlined in the guidance. 2016-04-30-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 700 2800 0

Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable No Health Consumer Health and Safety Private Sector 700 2800 0

2013-04-10-04:00

0910-0583 201208-0910-002 0910
             
        "Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plan Varieties Intended for Food Use"
             
          
        
The Food and Drug Administration (FDA) encourages developers of new plant varieties, including those varieties that are developed through biotechnology, to consult with FDA early in the development process to discuss possible scientific and regulatory issues that might arise. 2015-10-31-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 20 400 0

Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plan Varieties Intended for Food Use No Health Consumer Health and Safety Private Sector 20 400 0

2012-10-15-04:00

0910-0584 201303-0910-002 0910
             
        "Guidance for Reagents for Detection of Specific Novel Influenza A Viruses"
             
          
        
OMB clearance is being sought for an information collection that has been established as a special control for the class II device type, Novel Influenza A Reagents. This classification results from the review of a request from a device sponsor (CDC) for a diagnostic test intended to diagnose influenza subtype H5 (Asian lineage), commonly known as avian flu. This classification permits the legal distribution of this device, and the information collection addressed here plays a significant role in providing a reasonable assurance of the safety and effectiveness of this device and of similar future devices. Specifically, the information collection asks sponsors to obtain and analyze data postmarket to ensure the continued reliability of the device, given the propensity of influenza viruses to mutate and the potential for changes in disease prevalence. This involves collecting data on the clinical performance of the device under new prevalence conditions if there is a change in prevalence of influenza caused by the specific novel virus that the device is intended to detect, as compared to the prevalence of this virus when the clinical studies described in the 510(k) were conducted. 2016-04-30-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 20 300 0

Guidance for Reagents for Detection of Specific Novel Influenza A Viruses No Health Consumer Health and Safety Private Sector 20 300 0

2013-04-23-04:00

0910-0586 201106-0910-006 0910
             
        "Medical Devices; Exception from General Requirements for Informed Consent"
             
          
        
The information collections are associated with FDA's informed consent regulation, which provides an exception to the general requirement to obtain informed consent from the subject of an investigation involving an unapproved or not cleared in vitro diagnostic device intended to identify a chemical, biological, radiological, or nuclear agent. This regulation was issued under the statutory authority provided in section 520(g)(3)(D) of the Federal Food Drug and Cosmetic Act, which outlines the criteria under which an exemption from informed consent may be permissible. 2014-09-30-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 1350 1463 200

Medical Devices; Exception from General Requirements for Informed Consent No Health Consumer Health and Safety Private Sector 1350 1463 200

2011-09-05-04:00

0910-0594 201207-0910-004 0910
             
        "Draft Guidance for Industry and FDA Staff-Class II Special Controls:  Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle"
             
          
        
The special control draft guidance document serves to support the reclassification from class III to class II of the automated blood cell separator device that operates by either centrifugal or filtration separation principles intended for the routine collection of blood and blood components (21 CFR 864.9245). 2015-08-31-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 4 20 0

Annual Report - Draft Guidance for Industry and FDA Staff-Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle No Health Consumer Health and Safety Private Sector 4 20 0

2012-08-15-04:00

0910-0595 201301-0910-003 0910
             
        "Guidance:  Emergency Use Authorization of Medical Products"
             
          
        
The Commissioner of Food and Drugs may authorize the emergency use of unapproved medical products and unapproved uses of approved products if, among other things, data are submitted supporting a conclusion that statutory criteria for issuance of an authorization are met. The Commissioner also may establish conditions on the authorization, including recordkeeping and reporting requirements. Respondents include medical countermeasure manufacturers, as well as Federal, State, and local public health officials. 2016-03-31-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 224 1622 0

Requests to Issue an EUA or a Substantive Amendment to an Existing EUA No Health Consumer Health and Safety Private Sector 12 396 0

FDA Review of a Pre-EUA Package or an Amendment Thereto No Health Illness Prevention Private Sector 16 560 0

Manufacturers of an Unapproved EUA Product No Health Consumer Health and Safety Private Sector 8 16 0

Public Health Authorities; Unapproved EUA Product No Health Consumer Health and Safety Private Sector 90 180 0

Manufacturers of an Unapproved EUA Product No Health Consumer Health and Safety Private Sector 8 200 0

State and Local Public Health Officials; Unapproved EUA Product No Health Consumer Health and Safety Private Sector 90 270 0

2013-03-18-04:00

0910-0598 201304-0910-004 0910
             
        "CLIA Waiver Applications"
             
          
        
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) requires that clinical laboratories obtain a certificate from the Secretary of Health and Human Services before accepting materials derived from the human body for laboratory tests. Laboratories that perform only tests that are "so simple and accurate as to render the likelihood of erroneous results negligible" may obtain a certificate of waiver. The Secretary delegated to FDA the authority to determine under CLIA whether particular tests (waived tests) are "simple" and have "an insignificant risk of an erroneous result". Device manufacturers will submit to FDA an application for determination that a cleared or approved device meets this CLIA standard (CLIA waiver application). 2016-07-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 40 160000 350000

Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications No Health Consumer Health and Safety Private Sector 40 160000 350000

2013-07-02-04:00

0910-0599 201104-0910-004 0910
             
        "Cosmetic Labeling Regulations"
             
          
        
Under the authority of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act, the Food & Drug Administration has the authority to regulate the labeling of cosmetic products. The cosmetic labeling regulations in 21 CFR Part 701 require that cosmetic manufacturers, packers, and distributors label their products with a list of ingredients in descending order of predominance, a statement of the identity of the product, the establishment's name and place of business, and the net quantity of contents. 2014-06-30-04:00 Active Denver Presley 3018271462 No No No 141174 141174 0

21 CFR 701.3 Third Party Disclosure: Labeling Requirement For Cosmetic Products to Bear a Declaration of Ingredients in A Descending Order No Health Consumer Health and Safety Private Sector 31878 31878 0

21 CFR 701.11 - Third Party Disclosure: Labeling Requirement , Principal Display Panel of Cosmetic Product Must Bear a Statement of The Identity of The Product No Health Consumer Health and Safety Private Sector 36432 36432 0

21 CFR 701.12 Third Party Disclosure - Labeling Requirement - Label of a Cosmetic Product Must Specify The Name and Place of Business of the Manufacturer , Packer or Distributor No Health Consumer Health and Safety Private Sector 36432 36432 0

21 CFR 701.13 Third Party Disclosure- Labeling requirement : Label odf A cosmetic Product Must Declare the Net Quantity Contents of the Product No Health Consumer Health and Safety Private Sector 36432 36432 0

2011-06-27-04:00

0910-0601 201308-0910-003 0910
             
        "Manufactured Food Regulatory Program Standards"
             
          
        
The elements of the manufactured food regulatory program standards are intended to ensure that the States have the best practices of a high-quality regulatory program to use for self-assessment and continuous improvement and innovation. The ten standards describe the critical elements of a regulatory program designed to protect the public from foodborne illness and injury. These elements include the State program's regulatory foundation, staff training, inspection, quality assurance, food defense preparedness and response, foodborne illness and incident investigation, enforcement, education and outreach, resource management, laboratory resources, and program assessment. Each standard has corresponding self-assessment worksheets, and certain standards have supplemental worksheets and forms that will assist State programs in determining their level of conformance with the standard. FDA will use the program standards as a tool to improve contracts with State agencies. The program standards will assist both FDA and the States in fulfilling their regulatory obligations. 2016-09-30-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 44 13332 0

Manufactured Food Regulatory Program Standards - State Departments of Agriculture or Health No Health Consumer Health and Safety State, Local, and Tribal Governments 44 13332 0

Manufactured Food Regulatory Program Standards No Health Consumer Health and Safety State, Local, and Tribal Governments 0 0 0

2013-09-27-04:00

0910-0605 201312-0910-004 0910
             
        "Designation of New Animal Drugs for Minor Use or Minor Species (MUMS) - Final Rule"
             
          
        
The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provides incentives designed to help pharmaceutical companies overcome the financial burdens they face in providing limited-demand animal drugs. These incentives are only available to sponsors whose drugs are designated "MUMS" by FDA. Respondents to this collection, therefore, are sponsors of animal drugs used for minor animal species as well as uncommon diseases in major animal species who wish to obtain a MUMS designation for their products. Participation in the MUMS program is optional, however respondents must report certain information to the agency to obtain benefits offered by the MUMS program. 2017-02-28-05:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 157 1362 0

Designation of New Animal Drugs for Minor Use and MInor Species ( MUMS) No Health Consumer Health and Safety Private Sector 157 1362 0

2014-02-07-05:00

0910-0606 201009-0910-006 0910
             
        "Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements"
             
          
        
On October 25,1994, the Dietary Supplement Health and Education Act (DSHEA)(public Law 103-417) was signed into law. DSHEA, among other things, amended the Federal, Food, Drug and cosmetic Act(the act) by adding section (402(g) of the act ( 21 U.S.C.342(g). Section 402(g)(2) of the act provides in part, that the Scretary of Health and Human Services (the Scretary) may by regulation, prescribe good manufacturing practices ( CGMP) for dietary supplements. Section402(g) of the act stipulates that such regulations shall be modeled after CGMP regulations for food and may not impose standards for which there are no current and generally available , analytical methodology. Section402(g)(1) of the act states that a dietary supplement is adulterated if" it has been prepared,packed, or held under conditions that do not meet CGMP regulations." Under section 701 (a) of the act( 21 U.S.C. 371), FDA may issue regulations necessary for the efficient enforcement of the act. FDA published a final rule on June 25,2007 ( 72 FR 34752) ( the final rule) that established, in part 111 ( 21 CFR part 111), the minimum CGMP necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. 2014-02-28-05:00 Active Denver Presley 3018271462 No No No 719040 929140 0

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 0 0 0

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 0 0 0

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 0 0 0

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 0 0 0

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 0 0 0

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 0 0 0

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 0 0 0

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 0 0 0

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 0 0 0

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 0 0 0

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 0 0 0

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 0 0 0

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 0 0 0

Recordkeeping : Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 60000 60000 0

Recordkeeping : Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 15000 3000 0

Recordkeeping : Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 400 5000 0

Recordkeeping: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 250 11250 0

Recordkeeping: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 279120 558240 0

Recordkeeping: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 240 600 0

Recordkeeping: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 204160 204160 0

Recordkeeping: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 120 1800 0

Recordkeeping: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 260 520 0

Recordkeeping: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 50 630 0

Recordkeeping: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 15000 6000 0

Recordkeeping: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 440 5940 0

Recordkeeping: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 144000 72000 0

2011-02-27-05:00

0910-0607 201309-0910-010 0910
             
        "Administrative Procedures for Clinical Laboratory Improvement Amendments  of 1988 Categorization ( 42 CFR 493.17)"
             
          
        
This ICR describes the burden to manufacturers when they request Clinical Laboratory Improvement Amendments of 1998 (CLIA) categorization of in vitro diagnostic (IVD) tests when a premarket review is not needed (for example, devices exempt from premarket notification). In these cases, FDA recommends that manufacturers submit to FDA a brief description of why CLIA categorization is requested (e.g., exempt from 510(k), name change for a previously cleared device), the name of the device, the package insert (instructions for use), the product code, and regulation number. FDA will use the information collected to determine device complexity. There are three categories of test complexity: waived tests, moderate complexity tests, and high complexity tests. Laboratories performing only waived tests are subject to minimal regulation. Laboratories performing moderate or high complexity tests are subject to specific laboratory standards governing certification, personnel, proficiency testing, patient test management, quality assurance, quality control, and inspections. 2016-10-31-04:00 Active JonnaLynn Capezzuto jonnalynn.capezzuto@fda.hhs.gov 301 827-4659 No No No 900 900 46800

Request for CLIA categorization No Health Consumer Health and Safety Private Sector 900 900 46800

2013-10-23-04:00

0910-0608 201009-0910-008 0910
             
        "Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements"
             
          
        
On October 25,1994, the Dietary Supplement Health and Education Act (DSHEA)(Public Law 103-417) was signed into law. DHSEA, among other things, amended the Federal Food, Drug, and Cosmetic Act(the act) by adding section 402 (g) of the act (21 U.S.C. 342 (g) Section 402 (g)(2)of the act provides, in part, that the Secretary of Health and Human services (the secretary, may by regulation prescribe good manufacturing practices for dietary supplements. FDA published a final rule on June 25, 2007 (72 FR 34752) (the final rule) that established, in part 111 (21 CFR part 111) the minimum Current Good Manufacturing Practice (CGMP) necessary for activities related to manufactueing , packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. On June 25, 2007 (72 FR 34959 ), FDA also published an interin final rule 9 (the IFR ) establishing a procedure for a petition to request an exemption from 100 percent identity testing of dietary ingredients. 2014-02-28-05:00 Active Denver Presley 3018271462 No No No 1 8 0

Reporting: Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 1 8 0

Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements No Health Consumer Health and Safety Private Sector 0 0 0

2010-12-08-05:00

0910-0609 201010-0910-004 0910
             
        "Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables"
             
          
        
Fresh-cut fruits and vegetables are fruits and vegetables that have been processed by peeling, slicing, chopping, shredding, coring, trimming, or mashing, with or without washing or other treatment, prior to being packaged for consumption. The methods by which produce is grown, harvested, and processed may contribute to its contamination with pathogens and, consequently, the role of the produce in transmitting foodborne illness. Factors such as the high degree of handling and mixing of the product, the release of cellular fluids during cutting or mashing, the high moisture content of the product, the absence of a step lethal to pathogens, and the potential for temperature abuse in the processing, storage, transport, and retail display all enhance the potential for pathogens to survive and grow in fresh-cut produce. FDA recognizes the need for guidance specific to the processing of fresh -cut fruits and vegetables. The guidance document entitled " Guide to Minimize Microbial Food Safety hazards of Fresh cut Fruits and Vegetables", provides FDAs recommendations to fresh -cut processors about how to avoid contamination of their product with pathogens. Two general recommendations in the guidance are for operators to develop and implement both a written Standard Operating Procedures (SOPs) plan and a Sanitary Standard Operation Procedures (SSOPs) plan. SOPs and SSOPs are important components to properly implemented and monitored Good Manufacturing Practices (GMPs) that are required for processed food operations under part 110. Other recommended programs that require documentation and record keeping are recall and traceback programs. In the event of a food safety concern, processors who adopt these recommended programs will be prepared to recall products from the market place or be able to trace back fresh produce, which might be implicated in a foodborne illness outbreak, to its source. The recommended procedures contained in the guidance are voluntary. 2014-02-28-05:00 Active Denver Presley 3018271462 No No No 479270 47172 0

Recordkeeping: SOP and SSOP Maintenance No Health Consumer Health and Safety Private Sector 404430 27097 0

Recordkeeping: Traceback Development No Health Consumer Health and Safety Private Sector 10 200 0

Recordkeeping: Traceback Maintenance No Health Consumer Health and Safety Private Sector 290 11600 0

Recordkeeping : System Development - Preventive Control Program Comparable to a HACCP System No Health Consumer Health and Safety Private Sector 10 1000 0

Recordkeeping: System Implementation- Preventative Control Program Comparable to a HACCP System No Health Consumer Health and Safety Private Sector 73950 4955 0

Recordkeeping: System Implementation Review- Preventative Control Program Comparable to HACCP System No Health Consumer Health and Safety Private Sector 580 2320 0

2011-01-10-05:00

0910-0614 201104-0910-013 0910
             
        "Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile"
             
          
        
This information collection request covers certain reporting requirements associated with labeling requirements for the Strategic National Stockpile. 2014-08-31-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 3 56 0

201.26(b)(1)(i), 21CFR610.68(b)(1), 21CFR801.128(b)(1)(i), 21CFR809.11(b)(1)(i) No Health Consumer Health and Safety Private Sector 2 48 0

Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile No Health Consumer Health and Safety Private Sector 0 0 0

Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile No Health Consumer Health and Safety Private Sector 0 0 0

201.26(b)(1)(i), 21CFR610.68(b)(1), 21CFR801.128(b)(1)(i), 21CFR809.11(b)(1)(i) No Health Consumer Health and Safety Private Sector 1 8 0

2011-08-12-04:00

0910-0616 201109-0910-006 0910
             
        "Certification to Accompany Drug, Biological Product, and Device Applications or Submissions"
             
          
        
Sponsors of investigational new drug applications (IND) and marketing applications (NDA, BLA, PMA, 510k, HDE) are required, under the Food and Drug Administration Amendments Act of 2007, to certify that all applicable requirements have been met. Sponsors of applicable clinical trials are required to submit information to the publicly-accessible clinical trials data bank, ClinicalTrials.gov. 2015-02-28-05:00 Active Jonnalynn Capezzuto 3018274659 No No No 19353 6881 0

New Applications (IND) for CDER and CBER No Health Consumer Health and Safety
FDA 3674 Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of Clinical Trials.gov Data Bank (42 U.S.C. 282(j)) Yes Yes Fillable Fileable Signable Form and instruction FDA 3674.pdf http://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm No Printable Only Other OIRA0616_guidance_document_Final.doc
Private Sector 2033 508 0

Clinical Protocol Amendments (IND) for CDER and CBER No Health Immunization Management
FDA 3674 Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. 282(j)) Yes Yes Fillable Fileable Signable Form and instruction FDA 3674.pdf http://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm Yes No Printable Only Other OIRA0616_guidance_document_Final.doc
Private Sector 13240 3310 0

New Marketing Applications/Resubmissions (NDA/BLA) for CDER and CBER No Health Immunization Management
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm Yes No Printable Only Other OIRA0616_guidance_document_Final.doc FDA 3674 Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. 282(j)) Yes Yes Fillable Fileable Signable Form and instruction FDA 3674.pdf
Private Sector 165 124 0

Clinical Amendments to Marketing Applications for CDER and CBER No Health Immunization Management
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm Yes No Printable Only Other OIRA0616_guidance_document_Final.doc FDA 3674 Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. 282(j)) Yes Yes Fillable Fileable Signable Form and instruction FDA 3674.pdf
Private Sector 1483 1113 0

Efficacy Supplements/Resubmissions for CDER and CBER No Health Immunization Management
FDA 3674 Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. 282(j)) Yes Yes Fillable Fileable Signable Form and instruction FDA 3674.pdf http://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm Yes No Printable Only Other OIRA0616_guidance_document_Final.doc
Private Sector 191 144 0

New Marketing Applications for CDRH No Health Immunization Management
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm Yes No Printable Only Other OIRA0616_guidance_document_Final.doc FDA 3674 Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. 282(j)) Yes Yes Fillable Fileable Signable Form and instruction FDA 3674.pdf
Private Sector 892 669 0

Original Applications No Health Immunization Management
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm Yes No Printable Only Other OIRA0616_guidance_document_Final.doc FDA 3674 Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. 282(j)) Yes Yes Fillable Fileable Signable Form and instruction FDA 3674.pdf
Private Sector 854 641 0

Supplements/Amendments No Health Immunization Management
FDA 3674 Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. 282(j)) Yes Yes Fillable Fileable Signable Form and instruction FDA 3674.pdf http://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm Yes No Printable Only Other OIRA0616_guidance_document_Final.doc
Private Sector 495 372 0

2012-02-27-05:00

0910-0620 201104-0910-009 0910
             
        "Index of Legally Marketed Unapproved New Animal Drugs for Minor Species"
             
          
        
This information collection approval request is for a Food and Drug Administration (FDA) regulation that implements section 572 of the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The MUMS Act is made up of three sections (571, 572, and 573) and it establishes new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species as well as uncommon diseases in major animal species. Section 572 of the legislation provides for a public index listing of legally-marketed unapproved new animal drugs for minor species of animals. The drugs in this index are only indicated for use in non-food minor species or for use in early non-food life stages of food-producing minor species. This regulation, among other things, specifies the procedures for requesting eligibility and addition to the index as well as the annual reporting requirements for index holders. 2014-06-30-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 293 4922 0

516.119 No Health Consumer Health and Safety Private Sector 2 2 0

516.121 No Health Consumer Health and Safety Private Sector 60 240 0

516.123 No Health Consumer Health and Safety Private Sector 3 24 0

516.125 No Health Consumer Health and Safety Private Sector 6 120 0

516.129 No Health Consumer Health and Safety Private Sector 60 1200 0

516.141 No Health Consumer Health and Safety Private Sector 20 320 0

516.143 No Health Consumer Health and Safety Private Sector 20 2400 0

516.145 No Health Consumer Health and Safety Private Sector 20 400 0

516.161 No Health Consumer Health and Safety Private Sector 1 4 0

516.163 No Health Consumer Health and Safety Private Sector 1 2 0

516.165 No Health Consumer Health and Safety Private Sector 20 160 0

516.141 - Recordkeeping No Health Consumer Health and Safety Private Sector 60 30 0

516.165 - Recordkeeping No Health Consumer Health and Safety Private Sector 20 20 0

2011-06-27-04:00

0910-0621 201103-0910-014 0910
             
        "Voluntary National Retail Food Regulatory Program Standards"
             
          
        
While the responsibility for regulating retail and food service establishments lies primarily with State, local, and Tribal jurisdictions, FDA provides assistance to these jurisdictions through multiple means including, but not limited to, training and technical assistance. Authority for providing such assistance is derived from section 311 of the Public Health Service Act (42 U.S.C. 243). In addition, FDA's mission under section 903(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 393(b)(2)(A)) includes ensuring that foods are safe, wholesome, and sanitary, and section 903(b)(4) of the Act directs FDA to cooperate with food retailers, among others, in carrying out this part of its mission. The Centers for Disease Control and Prevention has identified the major contributing factors associated with foodborne illness outbreaks. Five of these contributing factors directly relate to retail and foodservice establishments and are called "foodborne illness risk factors" by FDA. In an effort to assist State, local, and Tribal regulators and the retail and food service entities they regulate, FDA has developed a Program Standards document entitled, "Voluntary National Retail Food Regulatory Program Standards." The Program Standards were developed with extensive input from state, tribal, and local regulatory authorities and are intended to help those authorities design and manage a retail food regulatory program that is focused on the reduction of foodborne illness risk factors. They are intended to capture the best management practices currently in use by state, tribal, and local regulatory authorities. The Program Standards initiative represents a comprehensive strategic approach that will help ensure the safety and security of the food supply at the retail level. 2014-05-31-04:00 Active Denver Presley 3018271462 No No No 3000 47395 0

Recordkeeping - Voluntary National Retail Food Regulatory Program Standards No Health Consumer Health and Safety State, Local, and Tribal Governments 500 47145 0

Reporting - Voluntary National Retail Food Regulatory Program Standards - Form FDA 3519 No Health Consumer Health and Safety
No No Paper Only Other DRAFT program standards for ICR.doc 3519 FDA National Registry Report Yes Yes Fillable Printable Form and instruction Form FDA 3519.mht
State, Local, and Tribal Governments 500 50 0

Reporting - Voluntary National Retail Food Regulatory S tandards - Form FDA 3520 No Health Consumer Health and Safety
No No Paper Only Other DRAFT_program_standards_for_ICR[1].doc 3520 Permission to Publish in National registry Yes Yes Fillable Printable Form and instruction Form FDA 3520I.mht
State, Local, and Tribal Governments 500 50 0

Reporting: Requests for Conference for Food Protection Training Plan and Log No Health Consumer Health and Safety State, Local, and Tribal Governments 1500 150 0

2011-05-19-04:00

0910-0622 201306-0910-008 0910
             
        "Foreign Clinical Studies Not Conducted Under an IND"
             
          
        
Under Section 312.120, sponsors submit foreign clinical studies not conducted under an Investigational New Drug as support for an IND or application for marketing approval for a drug or biological product. The studies must be conducted in accordance with Good Clinical Practice, including review and approval by an independent ethics committee. 2016-08-31-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 1185 37920 0

Foreign Clinical Studies Not Conducted Under an IND - 312.120 No Health Public Health Monitoring Federal Government 1185 37920 0

2013-08-16-04:00

0910-0623 201106-0910-008 0910
             
        "Request for Designation as Country not Subject to the Restrictions Applicable to Human Food and Cosmetics Manufactured from, Processed With, or Otherwise Containing, Material from Cattle"
             
          
        
Section 801(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 381(a)) provides requirements with regard to imported food and cosmetics and provides for refusal of admission into the United States of human food and cosmetics that appear to be adulterated. Section 701(b) of the FD&C Act (21 U.S.C. 371(b)) authorizes the Secretaries of Treasury and Health and Human Services to jointly prescribe regulations for the efficient enforcement of section 801 of the FD&C Act. To address the potential risk of bovine spongiform encephalopathy (BSE) in human food and cosmetics, FDA regulations in 189.5 and 700.27 (21 CFR 189.5 and 700.27) designate certain materials from cattle as "prohibited cattle materials," including specified risk materials, the small intestine of cattle not otherwise excluded from being a prohibited cattle material, material from nonambulatory disabled cattle, and mechanically separated (MS) (Beef). Under the regulations no human food or cosmetic may be manufactured from, processed with, or otherwise contain prohibited cattle materials. However, the Agency may designate a country from which cattle materials inspected and passed for human consumption are not considered prohibited cattle materials and their use does not render a human food or cosmetic adulterated. Sections 189.5(e) and 700.27(e) provide that a country seeking to be so designated must send a written request to the Director, Center for Food Safety and Applied Nutrition (CFSAN). Sections 189.5 and 700.27 further state that countries that have been designated under 189.5(e) and 700.27(e) will be subject to future review by FDA to determine whether designation remains appropriate. 2014-09-30-04:00 Active Denver Presley 3018271462 No No No 2 106 0

Reporting - Request for Designation No Health Consumer Health and Safety Private Sector 1 80 0

Reporting: Response to Request for Review by FDA No Health Consumer Health and Safety Private Sector 1 26 0

2011-09-05-04:00

0910-0625 201208-0910-003 0910
             
        "Electronic Submission of Medical Device Registration and Listing"
             
          
        
This information collection request covers the reporting and recordkeeping provisions associated with FDA's implementation of sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which require that device establishment registrations and listings under section 21 U.S.C. 360(p) (including the submission of updated information) be submitted to the Secretary by electronic means, unless the Secretary grants a request for waiver of the requirement because the use of electronic means is not reasonable for the person requesting the waiver. 2016-03-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 180585 99470 0

Annual Registration No Health Consumer Health and Safety
FDA 3673 3673 Yes Yes Fillable Fileable Signable Form Form FDA 3673 Screen shots.doc
Private Sector 20355 15266 0

Initial Registration & Listing No Health Consumer Health and Safety
FDA 3673 FDA 3673 Yes Yes Fillable Fileable Signable Form Form FDA 3673 Screen shots.doc
Private Sector 3539 1770 0

Annual Registration of Foreign Establishments No Health Consumer Health and Safety
FDA 3673 3673 Yes Yes Fillable Fileable Form Form_FDA_3673 Screen shots.doc
Private Sector 0 0 0

Annual Update of Changes to US Agent Information No Health Consumer Health and Safety
3673 FDA 3673 Yes Yes Fillable Fileable Signable Form Form FDA 3673 Screen shots.doc
Private Sector 1615 808 0

Annual Update of Listing Information No Health Consumer Health and Safety
3673 FDA 3673 Yes Yes Fillable Fileable Signable Form Form FDA 3673 Screen shots.doc
Private Sector 19875 19875 0

Initial Request for Waiver from Electronic Registration & Listing (recurring) No Health Consumer Health and Safety Private Sector 4 4 0

Annual Request for Waiver from Electronic Registration & Listing (one time) No Health Consumer Health and Safety Private Sector 14 14 0

List of Officers, Directors and Partners No Health Consumer Health and Safety Private Sector 23806 5952 0

Labeling & Advertisements Available for Review No Health Consumer Health and Safety Private Sector 46984 23492 0

Other Updates of Registration No Health Consumer Health and Safety Private Sector 4176 2088 0

Submittal of Manufacturer Information by Initial Importers (recurring) No Health Consumer Health and Safety Private Sector 25782 2578 0

Creation of electronic system account No Health Consumer Health and Safety Private Sector 3559 1780 0

Labeling & Advertisement Submitted at FDA Request No Health Consumer Health and Safety Private Sector 71 71 0

Initial Registration & Listing when Electronic Filing Waiver Granted (one time) No Health Consumer Health and Safety Private Sector 14 14 0

Annual Registration & Listing when Electronic Filing Waiver granted (recurring) No Health Consumer Health and Safety Private Sector 4 4 0

US Agent Responses to FDA Requests for Information No Health Consumer Health and Safety Private Sector 1535 384 0

Identification of initial importers by foreign establishments No Health Consumer Health and Safety
3673 FDA 3673 Yes Yes Fillable Fileable Signable Form Form FDA 3673 Screen shots.doc
Private Sector 10329 5165 0

Identification of other parties that facilitate import by foreign establishments No Health Consumer Health and Safety Private Sector 10329 5165 0

Submittal of Manufacturer Information by Initial Importers (One time) No Health Consumer Health and Safety Private Sector 8594 15040 0

2013-03-25-04:00

0910-0626 201108-0910-012 0910
             
        "Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act"
             
          
        
Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(6)) requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim have substantiation that the claim is truthful and not misleading. Under section 403(r)(6)(A) of the act (21 U.S.C. 343(r)(6)(A)), such a statement is one that claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption for a nutrient or dietary ingredient. The guidance document entitled, Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, provides the FDA recommendation to manufacturers about the amount, type, and quality of evidence they should have to substantiate a claim under section 403(r)(6). The guidance does not discuss the types of claims that can be made concerning the effect of a dietary supplement on the structure or function of the body, nor does it discuss criteria to determine when a statement about a dietary supplement is a disease claim. The guidance document is intended to assist manufacturers in their efforts to comply with section 403(r)(6). 2015-02-28-05:00 Active Denver Presley 3018271462 No No No 2001 189428 0

Reporting: Substantiation for Widely Known Established Dietary Supplement Claims No Health Consumer Health and Safety Private Sector 667 29348 0

Reporting: Substantiation for Pre-existing, Not Widely Established Dietary Supplement Claims No Health Consumer Health and Safety Private Sector 667 80040 0

Reporting: Substantiation for Novel Dietary Supplement Claims No Health Consumer Health and Safety Private Sector 667 80040 0

2012-02-06-05:00

0910-0627 201110-0910-008 0910
             
        "Substances Prohibited From Use in Animal Food or Feed - 21 CFR Part 589"
             
          
        
This is a request for OMB approval of the following information collection requirements: 21 CFR 589.2001 (c)(2)(ii) and (vi)- Recordkeeping, 21 CFR 589.2001 (c)(3)(i) - Recordkeeping 21 CFR 589.2001(c)(3)(i) (a) and (b) - Recordkeeping, 21 CFR 589.2001(b)(1) and 21 CFR 589.2001(f)-- Reporting-- New requirement that any foreign country seeking a designation from FDA that such country, due to a low BSE risk in that country, is not subject to the restrictions applicable to cattle materials prohibited in animal feed must submit a written request to the agency. The written request would have to include sufficient scientific evidence to support the claimed BSE risk status. These records will be subject to inspection by Federal and State agencies to ensure that animal food or feed does not contain protein which may cause the spread of BSE in this country. 2015-03-31-04:00 Active Denver Presley 3018271462 No No No 175 10114 200707

Substances Prohibited From Use in Animal Food or Feed - 21 CFR Part 589 No Health Consumer Health and Safety Private Sector 175 10114 200707

2012-03-30-04:00

0910-0629 201108-0910-005 0910
             
        "Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics"
             
          
        
The guidance document provides information concerning cooperative manufacturing arrangements applicable to biological products subject to licensure under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262). The guidance document addresses several different types of cooperative manufacturing arrangements (i.e., short supply arrangements, divided manufacturing arrangements, shared manufacturing arrangements, and contract manufacturing arrangements). The guidance document describes certain reporting and recordkeeping responsibilities associated with these arrangements, including the following: (1) Notification of all important proposed changes to production and facilities; (2) notification of results of tests and investigations regarding or possibly impacting the product; (3) notification of products manufactured in a contract facility; and (4) standard operating procedures. 2015-02-28-05:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 1 1 0

Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics No Health Consumer Health and Safety Private Sector 1 1 0

2012-02-27-05:00

0910-0630 201110-0910-004 0910
             
        "Requirements for Submission of In Vivo Bioequivalence Data"
             
          
        
The information is required to demonstrate that the applicant's drug is bioequivalent to a drug that has previously been approved by FDA and designated as an RLDT. 2015-01-31-05:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 72 3672 243648

Requirements for Submission of In Vivo Bioequivalence Data No Health Public Health Monitoring Private Sector 72 3672 243648

2012-01-16-05:00

0910-0632 201309-0910-012 0910
             
        "Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728 ( 21 U.S.C. 379j - 21)"
             
          
        
The Animal Generic Drug User Fee Act of 2008 (AGDUFA) (Title II of Public Law 110-316 signed by the President on August 14,2008), authorizes FDA to collect user fees for certain abbreviated applications for a generic new animal drug, on certain generic new animal drug products, and on certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. A generic animal drug application submitted by a person subject to application fees is considered incomplete and will not be accepted for filing by FDA until all fees owed by such person has been paid. AGDUFA requires the submission of the user fees concurrently with applications. If the required fees are not submitted, the review of the application will not begin. The "User Fee Cover Sheet" provides the information to either initiate or defer the application review. 2014-04-30-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 40 3 0

Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728 No Health Consumer Health and Safety
FDA 3728 AGDUFA Cover Sheet Yes Yes Fillable Fileable Form and instruction agdufa coversheet.pdf
Private Sector 40 3 0

2013-10-18-04:00

0910-0633 201111-0910-007 0910
             
        "Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300"
             
          
        
This request includes the third-party disclosures (i.e., labeling) associated with the guidance document Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300. 2015-03-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 102 1224 0

Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 No Health Consumer Health and Safety Private Sector 102 1224 0

2012-03-19-04:00

0910-0635 201205-0910-008 0910
             
        "Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act"
             
          
        
For Dietary Supplements, FDA requires the manufacturer, packer, or distributor whose name appears on the label to report all serious adverse event reports associated with the use of a dietary supplement via the MedWatch form. FDA is issuing guidance to describe the minimum data elements for serious adverse event reports for dietary supplements; how, when, and where to submit a serious adverse event report for a dietary supplement; and records maintenance and access for serious and non-serious adverse event reports and related documents. 2016-02-29-05:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 128600 77560 0

Serious adverse event reports for dietary supplements No Health Consumer Health and Safety Private Sector 8160 16320 0

Dietary supplement adverse events records No Health Consumer Health and Safety Private Sector 118400 59200 0

Follow-up reports of new medical information No Health Consumer Health and Safety Private Sector 2040 2040 0

2013-02-18-05:00

0910-0636 201206-0910-002 0910
             
        "Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application"
             
          
        
This guidance provides information on: (1) the meaning of "domestic Address" for purposes of the labeling requirements of section 502(x) of the act; (2) FDA's recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label under section 502(x)of the act. 2015-08-31-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 32500 125000 0

Reports of serious adverse drug events (21 U.S.C. 379aa((b) and (c)) No Health Public Health Monitoring Private Sector 12500 25000 0

Recordkeeping - (21 U.S.C. 379aa(e)(1)) No Health Public Health Monitoring Private Sector 20000 100000 0

2012-08-15-04:00

0910-0638 201106-0910-009 0910
             
        "Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices"
             
          
        
This guidance describes procedures for FDA, drug application holders, and AST device manufacturers to ensure that updated susceptibility test information is available to health care providers. 2014-11-30-05:00 Active Eliazabeth Berbakos 3018271482 No No No 2 32 0

Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices No Health Public Health Monitoring Private Sector 2 32 0

2011-11-08-05:00

0910-0641 201303-0910-001 0910
             
        "Guidance for Industry on Labeling for Products Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Act: Questions and Answers"
             
          
        
The guidance provides information on: (1) The meaning of "domestic address" for purposes of the labeling requirements of section 502(x) of the act; (2) FDA's recommendation for the use of an introductory statement before the domestic address or telephone number that is required to appear on the product label under section 502(x) of the act; and (3) FDA's intent regarding enforcing the labeling requirements of section 502(x) of the act. Public Law 109-462 also requires certain postmarketing safety reports for dietary supplements. 2016-04-30-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 100000 400000 0

Guidance for Industry on Labeling for Products Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Act: Questions and Answers No Health Public Health Monitoring Individuals or Households 100000 400000 0

2013-04-10-04:00

0910-0642 201210-0910-005 0910
             
        "Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act"
             
          
        
This ICR collects information from dietary supplement and non-prescription drug manufacturers and distributers seeking to introduce these products into interstate commerce under the FFDCA. Respondents provide the agency with proposed labeling for their products as required under the applicable statutes and FDA clears the labeling to ensure compliance so the products can be marketed. Products that do not comply with the applicable labeling regulations may be misbranded and subject to enforcement action. 2016-02-29-05:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 11120 2224 0

Contact information for Dietary Supplements and Non-Prescription Drugs No Health Consumer Health and Safety Private Sector 5560 1112 0

Introductory Statement for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act No Health Consumer Health and Safety Private Sector 5560 1112 0

2013-02-18-05:00

0910-0643 201103-0910-009 0910
             
        "Reporting and Recordkeeping Requirements for Reportable Food"
             
          
        
Section 1005 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85) amends the Federal Food, Drug, and Cosmetic Act (the act) by creating a new section 417 (21 U.S.C. 350f), among other things. Section 417 of the act defines "reportable food" as an "article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals." (Section 417(a)(2) of the act). Section 417 of the act requires FDA to establish an electronic portal (the Reportable Food electronic portal) by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. FDA made the decision that the most efficient and cost effective means to implement the requirements of section 417 of the act relating to the Registry was to utilize the business enterprise system currently under development within the agency: the MedWatchPlus Portal. In addition, Section 1005(f) of FDAAA required FDA to issue guidance to industry about submitting reports through the electronic portal of instances of reportable food and providing notifications to other persons in the supply chain of such article of food. FDA is issuing guidance containing questions and answers relating to the requirements under section 417 of the act, including (1) how, when and where to submit reports to FDA; (2) who is required to submit reports to FDA; (3) what is required to be submitted to FDA; and (4) what may be required when providing notifications to other persons in the supply chain of an article of food. 2014-08-31-04:00 Active Denver Presley 3018271462 No No No 6600 3330 0

Disclosure - FDAA-Section 417(d)(6)(B)(i)- Immediate Notification of Previous Source of The Article of Food. No Health Consumer Health and Safety Private Sector 1200 720 0

Disclosure- FDAA- Section 417(d)(6)(B)(ii)- Immediate Notification of Subsquent Recipient of The Article of Food No Health Consumer Health and Safety Private Sector 1200 720 0

Disclosure- FDAA - Section 417(d)(7)( C )( i )- Immediate Notification of Previous Source of The Article of Food. No Health Consumer Health and Safety Private Sector 1200 720 0

Disclosure: FDAAA - Section 417 ( d)((7)( C )( ii ) Immediate Notification of The Subquent Recipient of The Article of Food. No Health Consumer Health and Safety Private Sector 1200 720 0

Recordkeeping- FDAAA- Section 417(g)- Maintainence of Reportable Food Records (Mandatory ) No Health Consumer Health and Safety Private Sector 1200 300 0

Recordkeeping: FDAA- Section 417(g)- Maintainence of Reportable Food Records ( Voluntary Reports) No Health Consumer Health and Safety Private Sector 600 150 0

2011-08-22-04:00

0910-0645 201310-0910-003 0910
             
        "Electronic Submission of FDA Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal"
             
          
        
This ICR collects both mandatory and voluntary information regarding adverse events associated with FDA-regulated products that are submitted electronically using agency data-collection applications. Because the agency continues to move from a paper/manual submissions process for reporting adverse events to an electronic systems process, the scope of the ICR is limited to those product areas for which an electronic portal has been developed. Respondents include both manufacturers and distributers of FDA products, as well as individual consumers. The information collected enables FDA to identify potential public health threats and implement mitigation strategies as appropriate. 2016-04-30-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 1494577 897001 0

Voluntary Adverse Event Reporting via the SRP No Health Consumer Health and Safety Individuals or Households 1513 908 0

Mandatory Adverse Event Reporting via the SRP No Health Consumer Health and Safety Individuals or Households 636 636 0

Mandatory Adverse Event Reporting via ESG No Health Consumer Health and Safety Individuals or Households 1491228 894737 0

Reportable Food (human and animal) Mandatory View No Health Consumer Health and Safety
No No Printable Only Other guidance 3-11-2010.doc Yes No Printable Only Other RFR_proposed_SRP_modifications_12April12[1].doc FDA 1932 Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report Yes No Fillable Fileable Form and instruction FORM FDA 1932.pdf
Individuals or Households 1200 720 0

2013-11-22-05:00

0910-0646 201108-0910-007 0910
             
        "Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs"
             
          
        
The rulemaking requires the holder of an NDA to notify the agency when an authorized generic drug is marketed by clearly including this information in annual reports in an easily accessible place and by sending a copy of the relevant portion of the annual reports to a central office. FDA is taking this action to implement FDAAA which requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999 and that the agency update the list quarterly. FDA plans to publish this list on the Internet and to notify relevant Federal agencies that the list has been published and will be updated. 2014-02-28-05:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 1200 520 0

Authorized generic drug information in the first annual report submitted after the implementation of 314.81(b)(2)(ii)(b) No Health Public Health Monitoring Private Sector 400 400 0

Authorized generic drug information submitted in each subsequent annual report No Health Public Health Monitoring Private Sector 400 100 0

The submission of a copy of that portion of each annual report containing authorized generic drug information No Health Public Health Monitoring Private Sector 400 20 0

2012-10-22-04:00

0910-0650 201304-0910-006 0910
             
        "Tobacco Product Establishment Registration and Submission of Certain Health Information"
             
          
        
The FDA's Center for Tobacco Products is requesting that OMB approve the use of a more streamlined electronic submission system named FURLs to submit tobacco product registration and listing information in a more streamlined electronic way. The information collected will be the same as approved and collected on FDA Form 3741, and the FURLs system allows the users to log in instantly and begin data entry, saving weeks of submission time. FURLs also allows users to review and revise existing files, and is projected to reduce burden for Registration and Listing electronic entries by 35%. 2015-10-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 408 1092 2

Tobacco Product Establishment Registration No Health Immunization Management
Yes Yes Fillable Printable Other Import_905_Owner Establishment Registration_v1.xls Yes Yes Fillable Printable Other Import_905_Product Identification_v1.xls Yes Yes Fillable Printable Other Import_905_Operator Establishment Registration_v1.xls Yes No Printable Only Instruction Technical Working Instructions_clean_11_03_09.doc Yes No Printable Only Instruction AdobeDigitalSignatures.pdf Yes No Printable Only Instruction PackagingSubmissionUsingDigitalSignatures.pdf FDA 3741 Registration and Listing for Tobacco Product Establishments Yes Yes Fillable Fileable Signable Form FDA Form 3741.pdf Yes Yes Printable Only Instruction Create CTPe_Submissions UCM189565.pdf
Private Sector 200 488 1

Tobacco Product Ingredient Listing No Health Consumer Health and Safety
Yes No Printable Only Instruction Create CTPe_Submissions UCM189565.pdf FDA Form 3742 (e-submitter version) Listing of Ingredients in Tobacco Products Yes No Printable Only Form and instruction eSubmitter Product Listing screen shot-061512.pdf FDA Form 3742 Listing of Ingredients in Tobacco Products Yes No Printable Only Form and instruction FDA-3742 view only.pdf Yes No Printable Only Instruction PackagingSubmissionUsingDigitalSignatures.pdf Yes No Printable Only Instruction AdobeDigitalSignatures.pdf Yes No Printable Only Instruction eSubmitter Quick Guide UCM162419.pdf Yes Yes Fillable Printable Other Import_905_Product_Identification_v1.xls
Private Sector 200 600 1

Obtaining a Dun and Bradstreet D-U-N-S Number No Health Consumer Health and Safety Private Sector 8 4 0

2013-05-23-04:00

0910-0654 201308-0910-007 0910
             
        "Tobacco Health Document Submission"
             
          
        
FDA guidance on this collection requested health documents that were created during the period of June 23, 2009, through December 31, 2009. FDA is in the process of revising the April 2010 guidance but will continue collecting documents created during the period of June 23, 2009 through December 31, 2009, from any manufacturers, importers, or their agents who still have documents to submit. The information collected will inform FDA's development of good manufacturing practices, review standards for new tobacco products, and regulation of modified risk tobacco products, among others. Respondents submit information through a facilitative electronic form or in paper form using Form FDA 3743. In both forms, FDA is requesting the following information: Submitter identification, submitter point of contact, submission format and contents (as applicable), confirmation statement, document categorization (as applicable), document readability and accessibility, and document metadata. 2016-12-31-05:00 Active JonnaLynn Capezzuto jonnalynn.capezzuto@fda.hhs.gov 301 827-4659 No No No 8 400 208

Tobacco Health Document Submission No Health Consumer Health and Safety
3743 Tobacco Health Document Submission Yes Yes Fillable Fileable Signable Form and instruction FDA Form 3743.pdf
Private Sector 8 400 208

Tobacco Health Document Submission (Form FDA 3743) No Health Consumer Health and Safety
FDA 3743 Tobacco Health Document Submission Yes Yes Fillable Fileable Signable Form and instruction 0654 form FDA 3743 7-6-2010.pdf
Individuals or Households 0 0 0

2013-12-13-05:00

0910-0658 201303-0910-007 0910
             
        "Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water"
             
          
        
This collection request requires respondents to provide testing methods and results relating to the testing of bottled water processed or sold in the United States by US and foreign manufacturers. The reports and records are submitted to ensure compliance with currently approved testing regulation requirements. 2016-05-31-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 2223 179 0

bottlers subject to source water and finished product testing No Health Consumer Health and Safety Private Sector 1914 153 0

bottlers testing finished product only No Health Consumer Health and Safety Private Sector 285 23 0

bottlers conducting secondary testing of source water No Health Consumer Health and Safety Private Sector 15 1 0

bottlers rectifying contamination No Health Consumer Health and Safety Private Sector 9 2 0

2013-05-23-04:00

0910-0659 201304-0910-007 0910
             
        "Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 2008)"
             
          
        
This information collection requires that sponsors of each new animal drug that contains an antimicrobial agent submit an annual report to FDA on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. Its purpose is to ensure that the FDA has the necessary information to examine safety concerns related to the use of antibiotics in food-producing animals. With this revision of the information collection, FDA is adding a voluntary e-form FDA 3744a that will enable sponsors to submit electronically and capture all information as mandated by Section 105 of the Animal Drug User Fee Amendments of 2008. 2016-11-30-05:00 Active JonnaLynn Capezzuto jonnalynn.capezzuto@fda.hhs.gov 301 827-4659 No No No 350 9354 6975

Submission of Annual Reports for Sponsors with Active Applications (paper submission form FDA 3744) No Health Consumer Health and Safety
FDA 3744 ANTIMICROBIAL ANIMAL DRUG DISTRIBUTION REPORT Yes No Printable Only Form and instruction 0659 form FDA 3744 12-12-12.pdf
Private Sector 83 4980 6975

Annual Reports for Sponsors with Active Applications (e-form FDA 3744a) No Health Consumer Health and Safety
FDA 3744 Electronic Form FDA 3744 Antimicrobial Animal Drug Distribution Report for ADUFA Section 105 Yes Yes Fillable Fileable Form and instruction 0910-0659 FDA 3744a ADUFA eForm Screenshots Dec 2012.doc
Private Sector 80 4000 0

Annual Reports for Sponsors with Inactive Applications (paper submission form FDA 3744) No Health Consumer Health and Safety
FDA 3744 ANTIMICROBIAL ANIMAL DRUG DISTRIBUTION REPORT Yes No Printable Only Form and instruction 0659 form FDA 3744 12-12-12.pdf
Private Sector 81 162 0

Annual Reports for Sponsors with Inactive Applications (e-form FDA 3744a) No Health Consumer Health and Safety
FDA 3744 Electronic Form FDA 3744 Antimicrobial Animal Drug Distribution Report for ADUFA Section 105 Yes Yes Fillable Fileable Form and instruction 0910-0659 FDA 3744a ADUFA eForm Screenshots Dec 2012.doc
Private Sector 80 160 0

Requirement for All Applicants to Include Separate Information for Each Month in Their Records No Health Consumer Health and Safety
FDA 3744 ANTIMICROBIAL ANIMAL DRUG DISTRIBUTION REPORT Yes No Printable Only Form and instruction 0659 form FDA 3744 12-12-12.pdf
Private Sector 26 52 0

2013-11-08-05:00

0910-0660 201305-0910-007 0910
             
        "Prevention of Salmonella Enteritidis in Shell Eggs During Production---Recordkeeping and Registration Provisions"
             
          
        
This collection requires producers of shell eggs to maintain records and provide reports regarding the implementation of preventative measures to ensure that eggs contaminated with salmonella enteritidis do not reach the public marketplace. 2016-08-31-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 804134 390217 0

Prevention Plan Design No Health Consumer Health and Safety Private Sector 150 3000 0

Chick and Pullet Procurement Records No Health Consumer Health and Safety Private Sector 4731 2366 0

Rodent and Other Pest Control and Biosecurity Records No Health Consumer Health and Safety Private Sector 492024 246012 0

Cleaning and Disinfection Records No Health Consumer Health and Safety Private Sector 331 166 0

Refrigeration Records No Health Consumer Health and Safety Private Sector 135200 67600 0

Testing, Diversion or Treatment (Positive) No Health Consumer Health and Safety Private Sector 17836 8918 0

Testing, Diversion, and Treatment (Negative) No Health Consumer Health and Safety Private Sector 5965 2983 0

Prevention Plan Review and Modification No Health Consumer Health and Safety Private Sector 331 3310 0

Reporting Producer Registrations No Health Consumer Health and Safety
FDA 3733 SHELL EGG PRODUCER REGISTRATION FORM Yes Yes Paper Only Form and instruction Form 3733 7-15-09.doc
Private Sector 150 345 0

Environmental Testing No Health Consumer Health and Safety Private Sector 145084 36271 0

Egg Testing No Health Consumer Health and Safety Private Sector 2317 19231 0

Registration Cancellation No Health Consumer Health and Safety
FDA 3733 DHHS/FDA Shell Egg Producer Registration Yes Yes Fillable Fileable Form and instruction Form FDA 3733.pdf
Private Sector 15 15 0

2013-08-12-04:00

0910-0661 201304-0910-001 0910
             
        "Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements"
             
          
        
Under section 520(m) (21 U.S.C. 360j(m)) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the FDA is authorized to exempt a humanitarian use device (HUD) from the effectiveness requirements in sections 514 and 515 of the FD&C Act. HUDs are subject to the general restriction that no profit may be made on their use. For HUDs labeled for use in certain populations, FDA exempts a certain number of these devices each year from the prohibition on profit. This number is known as the ADN. The information gathered by this collection enables FDA to set this number. Failure to collect this information would prevent FDA from assigning an ADN. Section 520(m)(6)(A)(ii), as amended by FDASIA, provides that the Secretary of Health and Human Services (the Secretary) will assign an annual distribution number (ADN) for devices that meet the eligibility criteria to be permitted to be sold for profit.. The ADN is defined as the number of devices "reasonably needed to treat, diagnose, or cure a population of 4,000 individuals in the United States," and therefore shall be based on the following information in a humanitarian device exemption (HDE) application: the number of devices reasonably necessary to treat such individuals. FDA is requesting OMB approval for the collection of information required under the statutory mandate of sections 515A and 520(m) of the FD&C Act as amended. Reporting Requirements: Pediatric Subpopulation and Patient Information--Section 515A(a)(2) Requires that an HDE application include a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure and the number of affected pediatric patients. 2016-05-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 17 1370 0

Pediatric Subpopulation and Patient Information--515A(a)(2) of the FD&C Act No Health Consumer Health and Safety Private Sector 6 600 0

Exemption from Profit Prohibition Information--520(m)(6)(A)(i) and (ii) of the FD&C Act No Health Consumer Health and Safety Private Sector 3 150 0

ADN Notification--520(m)(6)(A)(iii) of the FD&C Act No Health Consumer Health and Safety Private Sector 1 100 0

ADN Modification--520(m)(6)(C) of the FD&C Act No Health Consumer Health and Safety Private Sector 5 500 0

Request for Determination of Eligibility Criteria--613(b) of FDASIA No Health Consumer Health and Safety Private Sector 2 20 0

2013-05-13-04:00

0910-0664 201101-0910-007 0910
             
        "Section 4205 of the Patient Protection and Affordable Care Act ( P.L. 111-148: Restaurant Menu Labeling : Registration For Small Chains"
             
          
        
In addition to restaurant menu and vending machine labeling, section 4205 of the "Affordable Care Act" provides that persons or firms not subject to the disclosure of nutrition information required by this legislation, such as chain restaurants with fewer than 20 locations or vending machine operators with fewer than 20 vencing machines may elect to be subject to the requirements provided under section 4205 by registering biannually with FDA. Under section 4205, FDA must publish notice in the FEDERAL REGISTER within 120 days of the date of enactment ot the legislation ( i.e. July 21, 2010), providing information on the terms and conditions for persons who voluntarily elect to be subject to nutition disclosue requirements specified in the legislation. 2014-04-30-04:00 Active Denver Presley 3018271462 No Yes No 724 820 0

Reporting- Registration for Restaurants ( initial) No Health Consumer Health and Safety
3757 DHHS/FDA MENU AND VENDING MACHINE VOLUNTARY REGISTRATION Yes Yes Fillable Printable Form and instruction Form FDA 3757.pdf
Private Sector 103 206 0

Reporting: Registration for Grocery ( initial) No Health Consumer Health and Safety
3757 DHHS / FDA MENU AND VENDING MACHINE LABELING VOLUNTARY REGISTRATION Yes Yes Fillable Printable Form and instruction Form FDA 3757.pdf
Federal Government 167 334 0

Reporting : Registration for C-store ( initial) No Health Consumer Health and Safety
3757 DHHS / FDA MENU AND VENDING MACHINE LABELING VOLUNTARY REGISTRATION Yes Yes Fillable Printable Form and instruction Form FDA 3757.pdf
Private Sector 11 22 0

Reporting: Registration for Other SRFE ( initial) No Health Consumer Health and Safety
3757 DHHS / FDA MENU AND VENDING MACHINE LABELING VOLUNTARY REGISTRATION Yes Yes Fillable Printable Form and instruction Form FDA 3757.pdf
Private Sector 81 162 0

Reporting - New Registrations ( recurring) No Health Consumer Health and Safety
3757 DHHS / FDA MENU AND VENDING MACHINE LABELING VOLUNTARY REGISTRATION Yes Yes Fillable Printable Form and instruction Form FDA 3757.pdf
Private Sector 7 7 0

Reporting - Re- registrations ( recurring) No Health Consumer Health and Safety
3757 DHHS / FDA MENU AND VENDING MACHINE LABELING VOLUNTARY REGISTRATION Yes Yes Fillable Printable Form and instruction Form FDA 3757.pdf
Private Sector 355 89 0

2011-04-25-04:00

0910-0665 201101-0910-008 0910
             
        "Section 4205 of the Patient Protection and Affordable Care Act Restaurant Menu Labeling; Recordkeeping and Mandatory Third Party Disclosure"
             
          
        
On March 23,2010, the President signed into law the Patient Protection and Affordable Care Act( P.L. 11-148)( the legislation or PPACA). Section 4205 of the legislation, which principally amends Sections 403 and 403A of the Federal Food Drug and Cosmetic Act ( the act), requires restaurants or similar retail food establishments (SRFE) with 20 or more locations doing business under the same name and offering for sale substantially the same menu items ("chain restaurants or similar retail food establishments") as well as owners or operators of 20 or more vending machines ("chain vending machines") to disclose cetain nutition information on certain food items offered for sale so that consumers can make more informed choices about the nutritional content of the food they purchase. Non-Federal nutrition labeling laws for chain restaurants or similar retail food establishments and vending machines are preempted. 2014-06-30-04:00 Active Denver Presley 3018271462 No Yes No 280907133 14531562 121355912

Recordkeeping-Restaurant Chains - Calorie Analysis and Recording No Health Consumer Health and Safety Individuals or Households 20124 80496 5413356

Recordkeeping- Grocery and Convenience Store Chains: Calorie Analysis and Recording No Health Consumer Health and Safety Private Sector 7600 30400 20444000

Recordkeeping- C-Store Chains: Calorie Analysis and Recording ( initial) No Health Consumer Health and Safety Private Sector 0 0 0

Recordkeeping: Other Chains - Calorie Analysis and Recording ( initial) No Health Consumer Health and Safety Private Sector 5600 22400 1506400

Recordkeeping: Vending Operators- Calorie Analysis and Recording ( initial) No Health Consumer Health and Safety Private Sector 4000 8000 17933

Recordkeeping: New Reformulated Items- Calorie Analysis and Recording ( recurring) No Health Consumer Health and Safety Private Sector 6024 24096 1620456

Recordkeeping: New Chains - Calorie Analysis and Recording ( recurring) No Health Consumer Health and Safety Private Sector 1800 7200 484200

Recordkeeping : New Vendors- Calorie Analysis and Recording (recurring) No Health Consumer Health and Safety Private Sector 60 120 4000

Third Party Disclosure: Restaurant Chains - Calorie Content No Health Consumer Health and Safety Private Sector 135705 271410 74637750

Third Party Disclosue: Grocery and Convenience Store Chains - Calorie Content No Health Consumer Health and Safety Private Sector 13982 27964 7689917

Third Party Disclosure: C-Store Chains- Calorie Content No Health Consumer Health and Safety Private Sector 0 0 0

Third Party Disclosure: Other Chains - Calorie Content No Health Consumer Health and Safety Private Sector 11038 22076 6070900

Third Party Disclosure: New Menu Items Calorie Content No Health Consumer Health and Safety Private Sector 0 0 0

Third Party Disclosure: New SRFE Outlets- Calorie Content No Health Consumer Health and Safety Private Sector 1200 2400 660000

Third Party Disclosure: Vending ( ongoing)- Calorie Content No Health Consumer Health and Safety Private Sector 280000000 14000000 2800000

Third Party Disclosure: Vending ( growth) Calorie Content No Health Consumer Health and Safety Private Sector 700000 35000 7000

SRFE Documents No Health Consumer Health and Safety Private Sector 0 0 0

2011-06-09-04:00

0910-0666 201306-0910-007 0910
             
        "Revision of the Requirements for Constituent Material"
             
          
        
Under 21 CFR 610.15(d)), the Director of the Center for Biologics Evaluation and Research (CBER) or the Director of the Center for Drug Evaluation and Research (CDER), may approve, as appropriate, a manufacturer's request for exceptions or alternatives to the regulation for constitutent materials. This provision provides manufacturers of biological products with flexibility, as appropriate, to employ advances in science and technology, as they become available without diminishing public health protections. The Director of CBER or CDER would use the information collected to approve, as appropriate, a manufacturer's request for an exception or alternative to the requirements for constituent materials. An exception or alternative will be considered for approval when the data submitted in support of such a request establish the safety, purity, and potency of the biological product for the conditions for which the applicant is seeking approval. 2014-02-28-05:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 1 1 0

Revision of the Requirements Constituent Material; Proposed Rule - 610.15(d) No Health Consumer Health and Safety Private Sector 1 1 0

2013-08-16-04:00

0910-0667 201307-0910-007 0910
             
        "Current Good Manufacturing Practices for Positron Emission Tomography Drugs"
             
          
        
This information collection includes the following current good manufacturing practices recordkeeping requirements: Batch Production and Control Records; Equipment and Facilities Records; Records of Components, Containers, and Closures; Process Vertification; Laboratory Testing Records; Sterility Test Failure Notices; Conditional Final Releases; Out-of-Specification Investigations; Reprocessing Procedures; Distribution Records; and Complaints. 2016-09-30-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 694402 147456 0

Batch Production and Control Records - 212.20(c) and (e); 212.50(a) and (b) No Health Consumer Health and Safety Private Sector 221 4420 0

Batch Production and Control Records - 212.20(d) and (e); 212.50(c); 212.80(c) No Health Consumer Health and Safety Private Sector 64629 64629 0

Equipment and Facilities Records - 212.20(c); 212.30(b); 212.50(d); 212.60(f) No Health Consumer Health and Safety Private Sector 1935 1935 0

Equipment and Facilities Records - 212.30(b); 212.50(d); 212.60(f) No Health Consumer Health and Safety Private Sector 484782 38783 0

Records of Components, Containers, and Closures - 212.20(c); 212.40(a) and (b) No Health Consumer Health and Safety Private Sector 258 258 0

Records of Components, Containers, and Closures - 212.40(e) No Health Consumer Health and Safety Private Sector 4644 2322 0

Laboratory Testing Records - 212.20(c); 212.60(a) and (b); 212.61(a); 212.70(a), (b), and (d) No Health Consumer Health and Safety Private Sector 3225 3225 0

Laboratory Testing Records - 212.60(g); 212.61(b); 212.70(d)(2) and (d)(3) No Health Consumer Health and Safety Private Sector 64629 10341 0

Conditional Final Releases - 212.70(f) No Health Consumer Health and Safety Private Sector 129 129 0

Out-of-Specification Investigations - 212.20(c); 212.71(a) No Health Consumer Health and Safety Private Sector 4644 4644 0

Out-of-Specification Investigations - 212.71(b) No Health Consumer Health and Safety Private Sector 129 129 0

Reprocessing Procedures - 212.20(c); 212.71(d) No Health Consumer Health and Safety Private Sector 129 129 0

Distribution Records - 212.20(c); 212.90(a) No Health Consumer Health and Safety Private Sector 129 129 0

Distribution Records - 212.90(b) No Health Consumer Health and Safety Private Sector 64629 16157 0

Complaints - 212.20(c); 212.100(a) No Health Consumer Health and Safety Private Sector 129 129 0

Complaints - 212.100(b) and (c) No Health Consumer Health and Safety Private Sector 129 65 0

Sterility Test Failure Notices - 212.70(e) No Health Consumer Health and Safety Private Sector 32 32 0

2013-09-16-04:00

0910-0669 201309-0910-007 0910
             
        "Abbreviated New Animal Drug Applications"
             
          
        
Respondents to this information collection are sponsors of abbreviated animal drug applications (ANADA) seeking approval of a generic copy of an approved new animal drug. These applications are required to contain information to demonstrate that the proposed generic drug is bioequivalent to, and has the same labeling as, the approved drug referenced in the application. Form FDA 356V must also be completed and accompamy each submission. 2016-10-31-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 33 3339 0

FD&C Act/ Section 512(n)(1) - Submission of a " Complete" ANADA by an Applicant No Health Consumer Health and Safety
FDA 356v Application for Approval of a New Animal Drug Yes Yes Fillable Fileable Form and instruction FDA Form 356v.pdf
Private Sector 18 2862 0

FD&C ACT/ Section 512(n)(1) - Phased Review Submission with Administrative ANADA No Health Consumer Health and Safety
FDA 356v Application for Approval of a New Animal Drug Yes Yes Fillable Fileable Form and instruction FDA Form 356v.pdf
Private Sector 15 477 0

2013-10-23-04:00

0910-0670 201309-0910-001 0910
             
        "Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims"
             
          
        
This guidance is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. The appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling. 2016-12-31-05:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 21 410 0

Submission to Docket Number FDA-2008-D-0150 No Health Consumer Health and Safety Private Sector 1 10 0

Cardiovascular Outcome Claim Supplement Submission No Health Consumer Health and Safety Private Sector 20 400 0

2013-12-02-05:00

0910-0671 201306-0910-004 0910
             
        "Requirements under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended by the Family Smoking Prevention and Tobacco Control Act"
             
          
        
This information collection--the submission to FDA of warning plans for smokeless tobacco products--is statutorily mandated. The Smokeless Tobacco Act requires that the warnings be displayed on packaging and advertising for each brand of smokeless tobacco "in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer" to, and approved by, FDA. The warning plans will be reviewed by FDA, to determine whether the companies' plans for the equal distribution and display of warning statements on packaging and the quarterly rotation of warning statements in advertising for each brand requires, among other things, that all smokeless tobacco product packages and advertisements bear one of four required warning statements. The Act does not specify the means for submission of warning plans. There are three ways to submit warning plans: electronic format submitted via the FDA Electronic Submission Gateway; electronic format submitted on physical media (e.g., CD or DVD); or paper format. 2016-08-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 100 6000 1200

Submission of rotational warning plans for health warning label statements No Health Public Health Monitoring Private Sector 100 6000 1200

2013-08-16-04:00

0910-0672 201311-0910-005 0910
             
        "Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans"
             
          
        
The information collection is intended to improve the utility of investigational new drug safety reports, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, and harmonize safety reporting requirements internationally. 2016-12-31-05:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 810 10120 1950

320.31(d) - Bioavailability and Bioequivalence Safety Reports No Health Consumer Health and Safety Private Sector 200 2800 950

312.32(c)(1)(ii) and (c)(1)(iii) - Investigational New Drug Safety Reports No Health Consumer Health and Safety Private Sector 600 7200 250

312.32(c)(1)(iv) - Investigational New Drug Safety Reports No Health Consumer Health and Safety Private Sector 10 120 750

2013-12-24-05:00

0910-0673 201105-0910-001 0910
             
        "Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product"
             
          
        
The FD&C Act requires FDA to issue an order after review of a premarket application before a new tobacco product may be commercially marketed. An order is not required, however, if a manufacturer submits a section 905(j)(1)(A)(i) report for the new tobacco product and FDA issues an order finding that the tobacco product is substantially equivalent to a tobacco product commercially marketed in the United States as of February 15, 2007, and in compliance with the Act. Manufacturers of these tobacco products may submit a report under section 905(j)(1)(A)(i) demonstrating that their new tobacco product is substantially equivalent to a predicate tobacco product. FDA issued a guidance document with recommendations on preparing substantial equivalence reports in which a tobacco manufacturer must show that a new tobacco product is substantially equivalent within the meaning of section 910 to a tobacco product commercially marketed in the U.S. as of February 15, 2007, or to a tobacco product that the Secretary has previously determined is substantially equivalent and in compliance with the Act. The comparison product chosen by the tobacco product manufacturer is referred to by FDA as the predicate tobacco product. For 905(j)(1)(A)(i) reporting, the new tobacco product is compared to a single predicate tobacco product to determine substantial equivalence. Section 905(j)(1)(A)(i) requires manufacturers who wish to demonstrate substantial equivalence for tobacco products commercially marketed after February 15, 2007 to include in their reports recommendations for providing information comparing the characteristics of the new and predicate tobacco product, including: 1) materials, 2) ingredients, 3) design, 4) composition, 5) heating source, or 6) other features. FDA recommends how to submit a section 905(j)(1)(A)(i) report in the issued guidance to ensure that manufacturers have time to prepare their 905(j) reports. 2014-07-31-04:00 Active Jonnalynn Capezzuto 3018274659 No No No 1000 360000 0

Reports Demonstrating Substantial Equivalence for Tobacco Products (Sections 905(j) and 910(a)) No Health Consumer Health and Safety Private Sector 1000 360000 0

2011-07-08-04:00

0910-0674 201301-0910-006 0910
             
        "Pretesting of Tobacco Communications"
             
          
        
In order to conduct educational and public information programs relating to tobacco use, as authorized by section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(D)), and to develop stronger health warnings on tobacco packaging as authorized by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), it is beneficial for the Food and Drug Administration (FDA) to conduct research and studies relating to the control and prevention of disease as authorized by section 301 of the Public Health Service Act (42 U.S.C 241(a)). In this generic collection of information, FDA will use formative pretests to assess the likely effectiveness of tobacco communications with specific target audiences. The information collected will serve two major purposes: (1) It will provide the critical knowledge needed about target audiences and the decisionmaking process when choosing to use, not use, or quit using tobacco products, including adolescents (ages 13 to 17) where communications will aim to discourage tobacco use before it starts. (2) It will allow FDA to assess the potential effectiveness of messages and materials in reaching and successfully communicating with their intended audiences. Pretesting messages with a sample of the target audience will allow FDA to refine messages while they are still in the developmental stage. 2016-03-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 16448 2860 0

Interviews with Tobacco Retailers to Inform Retailer Education No Health Immunization Management Individuals or Households 90 82 0

Focus Group Study of Youth Reactions to Creative Advertising Concepts Designed to Reduce Tobacco Use No Health Consumer Health and Safety Individuals or Households 288 126 0

Online Qualitative Study of Youth Reactions to Strategic Concepts Designed to Prevent Youth Tobacco Use No Health Immunization Management Individuals or Households 180 135 0

Online Quantitative Study of Youth Reactions to Rough-Cut Advertising Designed to Prevent Youth Tobacco Use No Health Immunization Management Individuals or Households 1575 528 0

Youth Reactions to Creative Advertising Concepts Designed to Reduce Tobacco Use among Multicultural Youth No Health Immunization Management Individuals or Households 580 192 0

2013-03-28-04:00

0910-0675 201011-0910-001 0910
             
        "Guidance for Industry on Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products"
             
          
        
The guidance is intended to encourage manufacturers of medically necessary drug products (MNPs) and any components of those products to develop contingency production plans to use during emergencies that result in high absenteeism at production facilities. The guidance provides recommendations regarding considerations for the development and implementation of a contingency production plan, including specific elements to include in such a plan. The guidance also discusses the Center for Drug Evaluation and Research's (CDER's) intended approach to helping to avoid drug product shortages that could have a negative impact on the national public health during such emergencies. The guidance is intended for manufacturers of finished drug products as well as manufacturers of the raw materials necessary for manufacturing an MNP. 2014-02-28-05:00 Active Eliazabeth Berbakos 3018271482 No No No 72 35032 0

Reporting - Notify FDA of Plan Activation and Deactivation No Health Consumer Health and Safety Private Sector 2 32 0

Record Keeping - Develop Initial Plan No Health Consumer Health and Safety Private Sector 70 35000 0

2011-01-06-05:00

0910-0677 201008-0910-002 0910
             
        "FOCUS GROUPS ABOUT DRUG PRODUCTS"
             
          
        
The Food and Drug Administration (FDA) is requesting approval for collecting information through the use of focus groups for studies involving drug products that are regulated by FDA. This information will be used as a first step to explore concepts of interest and assist in the development of quantitative study proposals, complementing other important research efforts in the agency. 2014-02-28-05:00 Active Eliazabeth Berbakos 3018271482 No No No 1440 2520 0

Investigation of Issues Related to Direct-to-Consumer (DTC) Advertising No Health Consumer Health and Safety Individuals or Households 1188 620 0

Examination of Online Direct-to-Consumer Prescription Drug Promotion No Health Immunization Management Individuals or Households 300 177 0

Investigating Online Drug Buying Knowledge and Attitudes" No Health Illness Prevention Individuals or Households 78 156 0

Testing Messages to Improve Consumer Knowledge about Prescription Drug Risks and Benefits No Health Illness Prevention Individuals or Households 144 288 0

Concept Testing for Online Pharmacy Communications Campaign No Health Illness Prevention Individuals or Households 66 132 0

Conducting Focus Groups & In Depth Interviews to Understand Perceptions Of/Attitudes toward FDA CDER Drug Safety Communications No Health Illness Prevention Individuals or Households 96 192 0

Focus Groups to Investigate Specific Terminology in Prescription Drug Promotion No Health Consumer Health and Safety Individuals or Households 162 284 0

2011-01-11-05:00

0910-0678 201011-0910-002 0910
             
        "Testing Communications On Medical Devices and Radiation-Emitting Products "
             
          
        
The Food and Drug Administration (FDA) is requesting approval for collecting information through a variety of research methods for developing and testing communications involving medical devices and radiation-emitting products that are regulated by FDA. This information will be used to assess the need for communications on specific topics and to assist in the development and modification of communication messages. FDA is authorized by Section 1003(d)(2)(D) of the Federal Food Drug and Cosmetic Act (21 U.S.C. Section 393(d)(2)(D))to conduct educational and public information programs relating to the safety of regulated medical devices and radiation-emitting products. 2014-02-28-05:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 8848 2076 0

Consumer Responses to Medical Device Labeling No Health Immunization Management Individuals or Households 500 250 0

2011-01-31-05:00

0910-0679 201102-0910-001 0910
             
        "Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act "
             
          
        
This information collection relates to the FDA's implementation of section 505(q) of the Federal Food, Drug, and Cosmetic Act. Section 505(q) includes requirements that certain citizen petitions and petitions for stay of Agency action include a certification and that supplemental information or comments to such petitions include a verification. This information collection covers the required certification and verification and a letter from the petitioner to withdraw a deficient petition for stay that is missing the certification. 2014-04-30-04:00 Active Eliazabeth Berbakos 3018271482 No No No 55 35 0

Certification for citizen petitions 505(q)(H) No Health Public Health Monitoring Individuals or Households 25 13 0

Certification for petitions for stay of agency action 505(q)(1)(H) No Health Public Health Monitoring Individuals or Households 3 2 0

Verification for comments to citizen petitions 505(q)(1)(I) No Health Public Health Monitoring Individuals or Households 12 6 0

Verification for comments to petitions for stay of agency action 505(q)(1)(I) No Health Public Health Monitoring Individuals or Households 2 1 0

Verifications for supplements to citizen petitions 505(q)(1)(I) No Health Public Health Monitoring Individuals or Households 10 5 0

Supplements to petitionss for stay of agency action No Health Public Health Monitoring Individuals or Households 1 6 0

Verification for supplements to petitions for stay of agency action 505(q)(1) (I) No Health Public Health Monitoring Individuals or Households 1 1 0

Letter withdrawing a petition for stay of agency action No Health Public Health Monitoring Individuals or Households 1 1 0

2011-04-25-04:00

0910-0680 201101-0910-005 0910
             
        "Pet Event Tracking Network (PETNet)--State, Federal Cooperation to Prevent Spread of Pet Food Related Diseases"
             
          
        
The PETNet program will allow FDA and its State partners to quickly and effectively exchange information about outbreaks of illness in companion animals associated with pet food. FDA has worked closely with its Federal and State partners to develop the PETNet, and believes that it will serve an important function in protecting the public and animal health. PETNet will be a secure, internet-based network comprised of the FDA, other Federal agencies, and State regulatory agencies/officials that have authority over pet food. The Network will provide timely and relevant information about pet food-related incidents to FDA, the States, and other Federal Government agencies charged with protecting animal and public health. 2014-04-30-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 500 167 0

Form 3756 No Health Public Health Monitoring
N/A FDA 3756 - Proof Form No No Printable Only Form FDA 3756 - Proof Form.pdf
Federal Government 500 167 0

2011-04-25-04:00

0910-0681 201101-0910-002 0910
             
        "Guidance for Industry:  Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion"
             
          
        
The guidance document notifies establishments that manufacture Whole Blood and blood components intended for use in transfusion, and establishments that make eligibility determinations for donors of HCT/Ps about FDA approval of a biologics license application for an enzyme-linked immunosorbent assay (ELISA) test system for the detection of antibodies to Trypanosoma cruzi (T. cruzi). The guidance also notifies establishments that make donor eligibility determinations for HCT/P donors that FDA has determined T. cruzi to be a relevant communicable disease under current regulations. In addition, the guidance provides recommendations for using a licensed test for antibodies to T. cruzi to test individual human donors, including donors of Whole Blood and blood components for transfusion and HCT/P donors (living and cadaveric (non-heart beating)), for antibodies to T. cruzi in plasma and serum samples. The guidance document does not apply to Source Plasma. 2014-04-30-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 1 1 0

Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion No Health Consumer Health and Safety Private Sector 1 1 0

2011-04-25-04:00

0910-0684 201106-0910-002 0910
             
        "Tobacco Products, Exemptions From Substantial Equivalence Requirements"
             
          
        
On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31) into law. The Act amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding a chapter granting FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. The Tobacco Control Act requires that before a new tobacco product may be introduced or delivered for introduction into interstate commerce, one of the following must occur: 1) a premarket application under section 910(b) of the FD&C Act must be submitted to FDA, and FDA must issue an order finding that the new product may be introduced or delivered for introduction into interstate commerce under section 910(c) of the FD&C Act; or 2) a report under section 905(j) of the FD&C Act demonstrating the new tobacco product's substantial equivalence to an appropriate predicate product must be submitted and FDA must issue an order finding the new product to be substantially equivalent to the predicate product and in compliance with the requirements of the Tobacco Control Act. This rule implements section 905(j)(3) of the FD&C Act, as amended, which states that FDA may exempt tobacco products that are modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, from the requirement of demonstrating substantial equivalence if the agency determines that (1) such modification would be a minor modification of a tobacco product that can be sold under the FD&C Act, (2) a report demonstrating substantial equivalence is not necessary to ensure that permitting the product to be marketed would be appropriate for the protection of public health, and (3) an exemption is otherwise appropriate. Section 905(j)(3)(B) of the FD&C Act requires FDA to issue regulations implementing this provision by July 1, 2011. 2014-08-31-04:00 Active Jonnalynn Capezzuto 3018274659 No No No 1900 14700 0

Tobacco Product Exemption from Substantial Equivalence Request 21 CFR 1107.1(b) No Health Public Health Monitoring Private Sector 500 6000 0

Additional Information for Tobacco Product Exemption from Substantial Equivalence Request 21 CFR 1107.1(c) No Health Public Health Monitoring Private Sector 150 450 0

Environmental Assessment Preparation under 25.40 No Health Public Health Monitoring Private Sector 500 6000 0

Report Demonstrating Tobacco Product Mod under 905(j)(3), Commercially Mkted and Compliant, and Modifications covered under 905(j)(3) No Health Public Health Monitoring Private Sector 750 2250 0

2011-08-03-04:00

0910-0686 201105-0910-010 0910
             
        "PRESCRIPTION DRUG ADVERTISEMENTS "
             
          
        
This information collection request accounts for FDA's prescription drug advertising regulations at 21 CFR 202.1, which describe requirements and standards for print and broadcast advertisements. 2014-06-30-04:00 Active Eliazabeth Berbakos 3018271482 No No No 18094 6702166 0

202.1(e)(6) No Health Immunization Management Private Sector 1 12 0

202.1(j)(1) No Health Immunization Management Private Sector 1 2 0

202.1(j)(1)(iii) No Health Immunization Management Private Sector 1 12 0

202.1(j)(4) No Health Immunization Management Private Sector 1405 28100 0

202.1 No Health Immunization Management Private Sector 16685 6674000 0

202.1(j)(1) No Health Immunization Management Private Sector 1 40 0

2011-06-01-04:00

0910-0687 201102-0910-004 0910
             
        "Testing Communications on Biological Products"
             
          
        
The Food and Drug Administration (FDA) is seeking approval from the Office of Management and Budget (OMB) for the generic clearance, Testing Communications on Biological Products. FDA is the regulatory agency responsible for the safety and effectiveness of medical products including biologics, drugs, foods, cosmetics, medical products, radiological products, and animal drugs. The purpose of the information collection is to provide tools to assess the need for communications on specific topics and to assist in the development and modification of communication messages to promote public health and compliance with regulations. FDA is requesting approval for collecting information through a variety of research methods for developing and testing communications involving biological, vaccine, and blood products. 2014-06-30-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 9280 2724 0 2011-06-01-04:00

0910-0688 201105-0910-004 0910
             
        "Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded"
             
          
        
FDA's legal authority to regulate the ingredients contained in over-the-counter (OTC) drug products derives from sections 321, 351, 352, 353, 355, 360, and 371 of the Federal Food, Drug, and Cosmetics Act (the act). FDA follows the procedures outlined in 21 CFR 330.10 for classifying active ingredients in OTC drug products as generally recognized as safe and effective (GRASE) and not misbranded 2014-06-30-04:00 Active Eliazabeth Berbakos 3018271482 No No No 4 7750 0

330.14 (f) and (i) No Health Public Health Monitoring Individuals or Households 2 4700 0

330.14 (c) and (d) No Health Public Health Monitoring Individuals or Households 2 3050 0

2011-06-13-04:00

0910-0689 201101-0910-001 0910
             
        "TESTING COMMUNICATIONS ON FDA-REGULATED PRODUCTS USED IN ANIMALS"
             
          
        
The Food and Drug Administration (FDA) is seeking approval from the Office of Management and Budget (OMB) for the generic clearance, Testing Communications on animal drugs, feed, food additives, and devices. FDA is the regulatory agency responsible for the safety and effectiveness of medical products including biologics, drugs, foods, cosmetics, medical products, radiological products, and animal drugs. The purpose of the information collection is to provide tools to assess the need for communications on specific topics and to assist in the development and modification of communication messages to promote public health and compliance with regulations. FDA is requesting approval for collecting information through a variety of research methods for developing and testing communications involving drug and other products for animals that are regulated by the FDA. 2014-07-31-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 7036 2298 0

Study on Decisionmaking to Avoid Drug Residues in Dairy Cows No Health Consumer Health and Safety Private Sector 30 23 0

2011-07-21-04:00

0910-0690 201202-0910-001 0910
             
        "Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products"
             
          
        
This information collection is required by the Family Smoking Prevention and Tobacco Control Act. It requires tobacco companies to maintain records records demonstrating their compliance with the requirements in section 801(e)(1) of the FD&C Act. Section 801(e)(1) requires exporters to keep records demonstrating that the exported product: (1) Meets with the foreign purchaser's specifications, (2) does not conflict with the laws of the foreign country, (3) is labeled on the outside of the shipping package that is intended for export, and (4) is not sold or offered for sale in the United States. These criteria also could be met by maintaining other documentation, such as letters from a foreign government Agency or notarized certifications from a responsible company official in the United States stating that the exported product does not conflict with the laws of the foreign country. 2015-03-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 474 10428 0

Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products No Health Public Health Monitoring Private Sector 474 10428 0

2012-03-30-04:00

0910-0691 201101-0910-009 0910
             
        "Experimental Study of Patient Information Prototypes"
             
          
        
The purpose of this study is to investigate the usefulness of two possible prototypes for patient medication information (PMI). FDA has an interest in providing useful and accessible information to patients when they retrieve their prescriptions at the pharmacy. In order to ensure that a standard format of information is most useful, we propose approaching this issue both qualitatively and quantitatively. These approaches will allow us to provide information about the readability, usefulness, and understandability of the two formats in a variety of populations, including those with the medical condition in question, people with low literacy levels, and members of the general public. We will compare the two prototypes to each other and to the existing Medication Guide format in order to obtain empirically based information about the most comprehensible and preferred document. This study will inform future policy with regard to PMI. 2014-08-31-04:00 Active Eliazabeth Berbakos 3018271482 No No No 4420 850 0

Phase I - Screener No Health Consumer Health and Safety Private Sector 400 13 0

Phase I - Interviews No Health Consumer Health and Safety Private Sector 90 90 0

Phase II - Screener No Health Consumer Health and Safety Private Sector 2600 87 0

Phase II - Pretest No Health Consumer Health and Safety Private Sector 30 10 0

Phase II - Questionnaire No Health Consumer Health and Safety Private Sector 1300 650 0

2011-08-11-04:00

0910-0692 201103-0910-005 0910
             
        "Study of Clinical Efficacy Information in Professional Labeling and Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs "
             
          
        
FDA regulations require that an advertisement that makes claims about a prescription drug include a "fair balance" of information about the benefits and risks of the advertised product, in terms of both content and presentation (21 CFR 202.1(e)(5)(ii)). In past research FDA has focused primarily on the risk component of the risk-benefit ratio. In the interest of thoroughly exploring the issue of fair balance, however, the presentation of effectiveness, or benefit, information is equally important. 2014-08-31-04:00 Active Eliazabeth Berbakos 3018271482 No No No 15512 1099 0

Screener, Physicians No Health Public Health Monitoring Individuals or Households 2272 38 0

Pretest, Physicians No Health Public Health Monitoring Individuals or Households 50 17 0

Qestionaire, Physicians No Health Public Health Monitoring Individuals or Households 500 167 0

screener, consumers No Health Public Health Monitoring Individuals or Households 10590 177 0

Pretest consumers No Health Public Health Monitoring Individuals or Households 100 33 0

Questionaire, consumers No Health Public Health Monitoring Individuals or Households 2000 667 0

2011-08-12-04:00

0910-0693 201108-0910-004 0910
             
        "Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products"
             
          
        
This information collection request covers the collections associated with "Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products," which provides recommendations to applicants considering whether to request a waiver or reduction in user fees assessed under Section 735 and 736 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). 2014-08-31-04:00 Active Eliazabeth Berbakos 3018271482 No No No 94 1524 0

Section 736 of the FD&C Act No Health Consumer Health and Safety Private Sector 90 1440 0

Reconsideration Requests No Health Consumer Health and Safety Private Sector 3 72 0

Appeal Requests No Health Consumer Health and Safety Private Sector 1 12 0

2011-08-16-04:00

0910-0695 201106-0910-004 0910
             
        "Request for Generic Clearance of FDA, Testing Communications On Drugs "
             
          
        
The purpose of the information collection is to provide tools to assess the need for communications on specific topics and to assist in the development and modification of communication messages to promote public health and compliance with regulations. FDA is requesting approval for collecting information through a variety of research methods for developing and testing communications involving drug products that are regulated by FDA. 2014-10-31-04:00 Active Eliazabeth Berbakos 3018271482 No No No 19822 4757 0

Consumer and Provider Understanding of Safety Issues around Online Purchase of Imported Drugs No Health Illness Prevention Individuals or Households 140 105 0

Testing Communications about FDA-regulated Products: Qualitative Feedback on FDA-generated Sunscreen Videos No Health Illness Prevention Individuals or Households 300 75 0

Consumer and provider understanding of safety issues around online purchase of imported drugs -- Modification to Restore Respondents No Health Illness Prevention Private Sector 260 195 0

Stimuli Development and Pretests for an Attentional Effects Study No Health Public Health Monitoring Individuals or Households 6180 455 0

2011-10-12-04:00

0910-0696 201202-0910-005 0910
             
        "Followup Study for Infant Feeding Practices Study II"
             
          
        
FDA is planning to conduct a survey of the mothers who participated in the Infant Feeding Practices Study II (IFPS II ) The purpose of the study is to enhance FDA`s understanding of the associations between infant feeding practices and diet quality, food allergy, overweight and obesity, and other health and development outcomes in young children. The study results will be used to help the Agency understand the possible role of infant feeding practices in the development and progression of food allergy and childhood overweight and obesity, in addition to resistance to infection and other health and development outcomes. The results of the study will not be used to develop population estimates. 2014-11-30-05:00 Active Denver Presley 3018271462 No No No 3540 832 0

Reporting : Pilot Study Mailed Questionnaire No Health Consumer Health and Safety Individuals or Households 91 38 0

Reporting: Pilot Study Telephone Interview No Health Consumer Health and Safety Individuals or Households 9 4 0

Reporting : Main Study Mailed Questionnaire No Health Consumer Health and Safety Individuals or Households 1538 508 0

Reporting: Main Study Telephone Interview No Health Consumer Health and Safety Individuals or Households 522 172 0

Reporting : Demographic Questionnaire No Health Consumer Health and Safety Individuals or Households 1380 110 0

2012-04-17-04:00

0910-0697 201105-0910-006 0910
             
        "Generic Clearance for the Collection of Qualitative Feedback on FDA Service Delivery"
             
          
        
The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with FDA's programs. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between FDA and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. 2014-11-30-05:00 Active Jonnalynn Capezzuto 3018274659 No No No 9100 4967 0

Request for Medical Product Safety Network (MedSun) Qualitative Feedback Generic Clearance about Newsletter Services No Health Consumer Health and Safety Private Sector 1200 300 0

Request for Qualitative Feedback Generic Clearance About FDA . gov Web Site Customers No Health Health Care Services Private Sector 206 206 0

Request for Surveys and Focus Groups in Support of FDA Programs for Small Pharmaceutical Businesses No Health Consumer Health and Safety Private Sector 2000 2000 0

2011-11-06-05:00

0910-0698 201107-0910-001 0910
             
        "National Consumer Surveys on Understanding the Risks and Benefits of FDA-Regulated Medical Products"
             
          
        
The information collected will be used by FDA in the development of more effective risk communication strategies and messages. FDA recognizes that these surveys should only be used for internal purposes (e.g., to better understand consumer perceptions). The data will not be used for the purposes of making policy or regulatory decisions. The surveys will provide FDA insight as to how well the public understands and incorporates risk/benefit information into their belief structures, and how well the public understands the context within which FDA makes decisions on medical product recalls and warnings. 2014-12-31-05:00 Active Jonnalynn Capezzuto 3018274659 No No No 9730 1428 0

Pretests No Health Immunization Management Individuals or Households 30 8 0

Screener No Health Immunization Management Individuals or Households 6700 670 0

Telephone Survey No Health Immunization Management Individuals or Households 1500 375 0

Internet Panel Survey No Health Immunization Management Individuals or Households 1500 375 0

2011-12-20-05:00

0910-0699 201212-0910-012 0910
             
        "Applications for Food and Drug Administration Approval to Market a New Drug; Revision of Postmarketing Reporting Requirements--Discontinuance"
             
          
        
The Food and Drug Administration (FDA) published an interim final rule on December 19, 2011 amending its postmarketing reporting regulations implementing certain provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act). The provisions of the FD&C Act require manufacturers who are the sole manufacturers of certain drug products to notify FDA at least 6 months before discontinuance of manufacture of the products. The interim final rule modified the term "discontinuance" and clarified the term "sole manufacturer" with respect to notification of discontinuance requirements. The broader reporting resulting from these changes will enable FDA to improve its collection and distribution of drug shortage information to physician and patient organizations and to work with manufacturers and other stakeholders to respond to potential drug shortages. 2016-02-29-05:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 85 240 0

Notification of Discontinuance No Health Consumer Health and Safety Private Sector 80 160 0

Certification of Good Cause No Health Consumer Health and Safety Private Sector 5 80 0

2013-02-08-05:00

0910-0700 201107-0910-002 0910
             
        "Guidance Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program"
             
          
        
This contains the collections associted with the FDA guidance document "Guidance for Industry, Third Parties and Food and Drug Administration Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program." 2015-02-28-05:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 2133 27186 63990

First Year (one time) No Health Immunization Management Private Sector 533 22386 15990

Recurring No Health Immunization Management Private Sector 1600 4800 48000

2012-02-06-05:00

0910-0701 201107-0910-010 0910
             
        "Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic "
             
          
        
The guidance recommends that each firm's pandemic influenza continuity of operations plan (COOP) include instructions for reporting adverse events and a plan for the submission of stored reports that were not submitted within regulatory timeframes. The guidance indicates which reports may generally be stored if necessary because of pandemic-related high employee absenteeism, without FDA objection. However, any delayed reports must be submitted after adverse event reporting processes have been restored to the pre-pandemic state. Firms should maintain records to identify what has been stored and when the processes were restored. 2015-02-28-05:00 Active Eliazabeth Berbakos 3018271482 No No No 6500 262000 0

Notify FDA when normal reporting is not feasible No Health Public Health Monitoring Individuals or Households 500 4000 0

One time - add adverse event reporting plan to COOP No Health Public Health Monitoring Individuals or Households 5000 250000 0

Maintain documentation of influenze pandemic conditions and resultant high absenteeism No Health Public Health Monitoring Individuals or Households 500 4000 0

Maintain records to identify what reports have been stored and when the reporting process was restored No Health Public Health Monitoring Individuals or Households 500 4000 0

2012-02-06-05:00

0910-0702 201306-0910-009 0910
             
        "Orphan Drug Regulations"
             
          
        
Amendments to these regulations are intended to clarify regulatory provisions and make minor improvements to address isues that have arisen since the issuance of the regulations in 1992. They are intended to assist sponsors who are seeking and who have obtained orphan--drug designations, as well as FDA in its administration of the orphan drug program. 2016-09-30-04:00 Active JonnaLynn Capezzuto jonnalynn.capezzuto@fda.hhs.gov 301 827-4659 No No No 30 64 0

Content and format of a request for orphan-drug designation No Health Immunization Management Private Sector 20 4 0

Granting orphan-drug designation No Health Immunization Management Private Sector 10 60 0

2013-09-16-04:00

0910-0703 201211-0910-002 0910
             
        "Experimental Study of Format Variations in the Brief Summary of Direct-to-Consumer (DTC) Print Advertisements "
             
          
        
Section 502(n) of the Federal Food, Drug, and Cosmetic Act specifies that ads for prescription drugs and biological products must provide a true statement of information "in brief summary" about the advertised product's "side effects, contraindications, and effectiveness." The prescription drug advertising regulations (21 CFR ? 202.1(e)(3)(iii); Appendix B) specify that the information about risks must include each specific side effect and contraindication from the advertised drug's FDA-approved labeling, including the Warnings, Precautions, Adverse Reactions, and other relevant sections. Some of the current approaches to fulfilling the brief summary requirement, while adequate from a regulatory perspective, result in ads that may be difficult to read and understand when used in consumer-directed promotion. In recent years, FDA has become concerned about the adequacy of the brief summary in DTC print advertisements for prescription drugs. Because the regulations do not specify how to address each risk, sponsors can use discretion in fulfilling the brief summary requirement under ? 202.1(e)(3)(iii). Frequently, sponsors print in small type, verbatim, the risk-related sections of the approved product labeling (also called the package insert, professional labeling, prescribing information, and direction circular). 2015-02-28-05:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 80868 6221 0

Number to Complete the Screener No Health Immunization Management Individuals or Households 69118 2304 0

Number to Complete the Survey No Health Immunization Management Individuals or Households 11750 3917 0

2012-11-09-05:00

0910-0704 201107-0910-003 0910
             
        "Guidance on Consultation Procedures: Foods Derived From New Plant Varieties"
             
          
        
FDA instituted a voluntary consultation process with industry to promote communication and to ensure that any potential food safety issues regarding a new plant variety are resolved during development, and will help to ensure that all market entry decisions by the industry are made consistently and in full compliance with the standards of the FD&C Act. 2015-02-28-05:00 Active Denver Presley 3018271462 No No No 52 1960 0

Reporting: Initial Consultation No Natural Resources Agricultural Innovation and Services Private Sector 40 160 0

Reporting: Final Consultation No Natural Resources Agricultural Innovation and Services
3665 Final Consultation For Food Derived From A New Plant Variety Yes Yes Fillable Printable Form and instruction FDA-3665 Form_B _v3 0_RD-03-01-11.pdf
Private Sector 12 1800 0

2012-02-27-05:00

0910-0705 201212-0910-007 0910
             
        "Draft Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act"
             
          
        
Section 513 of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the act) (21 U.S.C. 360c, et seq.) provides for the classification of devices intended for human use. Under section 513(a), devices are classified by the regulatory controls needed to provide reasonable assurance of their safety and effectiveness into class I (general controls), class II (special controls), or class III (premarket approval). Section 513(g) provides a means of obtaining information from FDA regarding the classification and regulatory requirements that may be applicable to a particular device; specifically, that within 60 days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under the act, the Secretary of Health and Human Services shall provide such person a written statement of the classification (if any) of such device and the requirements of this act applicable to the device. 2015-03-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 114 1368 0

FD&C Act 513(g) No Health Public Health Monitoring Private Sector 114 1368 0

2012-12-19-05:00

0910-0706 201206-0910-013 0910
             
        "Comparing Nutrition Knowledge,  Attitude, and Behavior Among English Dominant Hispanics,  Spanish Dominant Hispanics, and Other Consumers"
             
          
        
FDA conducts research and educational and public information programs relating to food safety pursuant to its broad statutory authority set forth in section 903(b)(2) of the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 393(b)(2). FDA needs an understanding of how different population groups perceive and behave in terms of food label understanding and use, nutrition, and health, to inform possible measures that the Agency may take to help consumers make informed dietary choices. FDA is aware of no consumer research on a nationwide level, of the impact of language and accculturation ( change in behavior and values by immigrants when they come in contact with a new group , nation or culture )on Hispanics` dietary choices and label use. 2014-04-30-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 7821 826 0

Reporting: Cognitive Interview Screener No Health Consumer Health and Safety Individuals or Households 72 6 0

Reporting: Cognitive Interview No Health Consumer Health and Safety Individuals or Households 9 5 0

Reporting: Pretest Invitation No Health Consumer Health and Safety Individuals or Households 360 12 0

Reporting: Pretest No Health Consumer Health and Safety Individuals or Households 180 45 0

Reporting: Survey Invitation No Health Consumer Health and Safety Individuals or Households 4800 158 0

Reporting: Survey No Health Consumer Health and Safety Individuals or Households 2400 600 0

2012-07-20-04:00

0910-0707 201307-0910-005 0910
             
        "Experimental Study of Comparative Direct-to-Consumer (DTC) Advertising "
             
          
        
The present study aims to investigate how consumers interpret and react to DTC comparative drug ads. Specifically, the study will explore two types of drug comparisons in DTC ads: (1) drug efficacy comparisons and (2) other evidence-based comparisons, such as dosing, mechanism of action, and indication. The study findings will inform FDA of relevant consumer issues relating to comparative DTC advertising. 2015-04-30-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 26930 3240 0

Screener No Health Illness Prevention Individuals or Households 19120 637 0

Pretests No Health Illness Prevention Individuals or Households 750 250 0

Questionnaires No Health Illness Prevention Individuals or Households 7060 2353 0

2013-07-26-04:00

0910-0708 201111-0910-001 0910
             
        "Data to Support Communications to Educate Consumers on How to Safely Purchase Drugs Online"
             
          
        
FDA will use the data collected under this clearance to inform and evaluate its integrated outreach campaign designed to help consumers safely purchase drugs online. FDA expects the data to provide a baseline the target audience and track ongoing progress toward its online pharmacy campaign goals and objectives. FDA also plans to use the data to help tailor print, broadcast, and electronic media communications to have powerful and desired impacts on target audiences. The data will not be used for the purposes of making policy or regulatory decisions. 2015-05-31-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 5000 1650 0

Online Survey Questionnaire - Data To Support Communications To Educate Consumers On How To Safely Purchase Drugs Online No Health Illness Prevention Individuals or Households 5000 1650 0

2012-05-11-04:00

0910-0710 201105-0910-009 0910
             
        "Data to Support Food and Nutrition Product Communications as Used by the Food and Drug Administration"
             
          
        
FDA is seeking generic clearance for this collection of information and plans to use the data to inform its nutrition and foods communications campaigns. The informatiion will serve two major purposes. First as formative research, it will provide the critical knowlwdge needed about target audiences. Second, as initial testing, it will give FDA some information about the potential effectiveness of the messages and materials in reaching and successfully communicating with their intended audiences. 2014-06-30-04:00 Active Denver Presley 3018271462 No No No 16448 2860 0 2012-06-11-04:00

0910-0711 201106-0910-007 0910
             
        "Real Time Surveys of Consumers` Knowledge, Perceptions and Reported Behavior Concerning Foodborne Illness Outbreaks or Food Recalls"
             
          
        
Under section 903 (b)(2) of the Federal Food, Drug and Cosmetic Act ( FFDCA)( 21 U.S.C. 393 (b)(2), the Food and Drug Administration ( FDA) is authorized to conduct research relating to foods and to conduct educational and public information programs relating to the safety of the Nation`s food supply. FDA is proposing to survey U.S. consumers using a web-based panel of U.S. households to collect information on consumers "real time" knowledge, perceptions, beliefs, and self- reported behaviors for up to five foodborne illness outbreaks or food recalls a year. Collecting information quickly during a foodborne illness outbreak or food recall is important because erroneous perceptions or misinterpreted information about outbreak or recall can impede consumer adoption of recommended protective behaviors. 2014-06-30-04:00 Active Denver Presley 3018271462 No No No 75200 4758 0

Real Time Surveys of Consumers` Knowledge, Perceptions and Reported Behavior Concerning Foodborne Illness Outbreaks or Food Recalls No Health Consumer Health and Safety Individuals or Households 600 35 0

Frozen Berries Recall - Link to Hepatitis A No Health Consumer Health and Safety Individuals or Households 10000 1725 0

Bagged Salad and Cyclospora No Health Consumer Health and Safety Individuals or Households 10000 1725 0

2012-06-11-04:00

0910-0712 201108-0910-009 0910
             
        "Data to Support Communications Usability Testing, as Used by the Food and Drug Administration"
             
          
        
FDA plans to use the data collected under this generic clearance to inform its communications campaigns on a variety of topics related to products that the FDA regulates. FDA expects the data to help staff message developers achieve FDA communication objectives. FDA also plans to use the data to help tailor print, broadcast, and electronic media communications in order for them to have powerful and desired impacts on target audiences. The data will not be used for the purposes of making policy or regulatory decisions. 2014-06-30-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 75000 41041 0 2012-06-11-04:00

0910-0713 201301-0910-005 0910
             
        "Experimental Study: Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions"
             
          
        
This study will examine what effect, if any, the presence of price incentive promotional offers in DTC prescription drug ads have on the following: (1) Consumers' perceptions of product risks and benefits, (2) recall of product risks and benefits, and (3) strongly held beliefs that may act as potential moderators. 2015-06-30-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 15344 2561 0

Screener No Health Illness Prevention Individuals or Households 8500 283 0

Pretests No Health Illness Prevention Individuals or Households 994 328 0

Study 1 - Online No Health Illness Prevention Individuals or Households 1950 650 0

Study 1 - Mall Intercept No Health Illness Prevention Individuals or Households 1950 650 0

Study 2 No Health Illness Prevention Individuals or Households 1950 650 0

2013-01-29-05:00

0910-0714 201212-0910-003 0910
             
        "Examination of Online Direct-to-Consumer Prescription Drug Promotion"
             
          
        
FDA regulations require that prescription drug advertisements include a "fair balance" of information about the benefits and risks of advertised products, both in terms of the content and presentation of the information (21 CFR 202.1(e)(5). All prescription drug promotion that makes claims about a product must, therefore, also include risk information in a "balanced" manner. Currently, there are a number of questions surrounding how to achieve "fair balance" in online direct-to-consumer (DTC) promotion. This project is designed to test different ways of presenting prescription drug risk and benefit information on branded drug websites. This research is relevant to current policy questions and debate and will complement qualitative research we plan to conduct on issues surrounding social media ("Examination of Online Direct-to-Consumer Prescription Drug Promotion"; OMB Control No. 0910-0677). The series of studies described in this notice will provide data that, along with other input and considerations, will inform the development of future guidance. 2015-07-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 26200 4883 0

Screener (Part of Survey Instruments) No Health Illness Prevention Individuals or Households 16000 533 0

Pretests No Health Illness Prevention Individuals or Households 1200 600 0

Study 1 No Health Illness Prevention Individuals or Households 6000 2500 0

Study 2 No Health Illness Prevention Individuals or Households 2000 833 0

Study 3 No Health Illness Prevention Individuals or Households 1000 417 0

2012-12-12-05:00

0910-0715 201203-0910-001 0910
             
        "Survey of "Health Care Providers' Responses to Medical Device Labeling""
             
          
        
This is a survey to inform FDA's development of evidence-based guidelines and federal regulations for the content and format (headings, layout, word choices, tables and diagrams) of medical device labeling. The anticipated final outcome will be standardized medical device labeling that will lead to an increase in the safe and effective use of medical devices, and a reduction in adverse events associated with the use of medical devices. This data collection from the private sector is an important element for the Agency to use in evaluating the existing problems associated with current medical device labeling. 2015-07-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 1248 324 0

Survey of "Health Care Providers' Responses to Medical Device Labeling Content No Health Immunization Management Private Sector 1248 324 0

2012-07-05-04:00

0910-0716 201310-0910-001 0910
             
        "Potential Tobacco Product Violations Reporting Form"
             
          
        
FDA created the Tobacco Call Center with a toll-free number to accept information from the public regarding potential violations of the Tobacco Control Act. Callers report potential violations of the Tobacco Control Act and FDA may conduct targeted follow-up investigation based on information received. When callers report a potential violation, the caller will be asked to provide as much information about the violation as they can recall, including: the date the potential violation happened, product type (e.g., cigarette, smokeless, roll-your-own, etc.), tobacco brand, type of potentially violative promotional materials, potential violation type, who potentially violated, and the name, address, phone number, and e-mail address of the potential violator. The caller will be asked to list the potential violator's website, describe the potential violation, and provide any additional files or information. FDA has developed FDA Form 3779, Potential Tobacco Production Violations Reporting that will be used to solicit this information from the caller. This form is intended to eventually replace FDA Form 3734 Cigarette Flavor Ban Violations Form. This new form will be posted on FDA's website to complete on-line or the public can download it or request a copy of the form by contacting the Center for Tobacco Products. In addition, FDA has developed a smartphone application for use with mobile devices (i.e., iPhones, Android) to allow consumers to report potential violations to the FDA via their smartphone. Other stakeholders may simply choose to send a letter to FDA with their information. The public and interested stakeholders will be able to report information regarding possible violations of the Tobacco Control Act by calling the Tobacco Call Center using CTP's toll-free number; using a fill-able form found on FDA's Web site; using FDA's tobacco violation reporting smartphone application; or sending a letter to FDA's Center for Tobacco Products 2014-07-31-04:00 Active JonnaLynn Capezzuto jonnalynn.capezzuto@fda.hhs.gov 301 827-4659 No No No 1000 250 5

Potential Tobacco Product Violations Reporting No Health Immunization Management
FDA Form 3779 Potential Yes Yes Paper Only Form FDA 3779 Paper form.pdf
Individuals or Households 1000 250 5

2013-11-22-05:00

0910-0717 201205-0910-007 0910
             
        "SPF Labeling and Testing Requirements for OTC Sunscreen Products"
             
          
        
Under the 2011 final rule, OTC sunscreen products are required to be tested according to the SPF test procedure in 21 CFR 201.327(i). The SPF test demonstrates a product's effectiveness in protecting against sunburn. A product's numerical SPF value, as determined by the SPF test, reflects the level of sun protection provided by the product. The 2011 final rule requires that an OTC sunscreen product be labeled with its SPF value on its principal display panel according to labeling requirements in 21 CFR 201.327(a)(1). Requiring labeling with SPF values allows consumers to compare the levels of sunburn protection between sunscreen products. The requirement to label OTC sunscreen products with an SPF value determined by the SPF test results in an information collection with a third-party disclosure burden for manufacturers of OTC sunscreen products covered by the final rule. The 2011 final rule also lifts the delay of implementation date of the Drug Facts regulation (21 CFR 201.66) for all OTC sunscreens effective June 18, 2012. Compliance with the Drug Facts regulation results in an additional third-party disclosure burden for manufacturers of OTC sunscreen products covered by the final rule. 2015-08-31-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 6734 73986 0

Conduct SPF testing in accordance with 201.327(i) for existing sunscreen formulations No Health Illness Prevention Individuals or Households 1175 28200 0

Conduct SPF testing in accordance with 201.327(i) for new sunscreen formulations No Health Illness Prevention Individuals or Households 39 936 0

Create PDP labeling in accordance with 201.327(a)(1) for existing sunscreen SKUs No Health Illness Prevention Individuals or Households 1800 900 0

Create PDP labeling in accordance with 201.327(a)(1) for new sunscreen SKUs No Health Illness Prevention Individuals or Households 60 30 0

Format labeling in accordance with 201.66(c) and (d) for existing sunscreen SKUs No Health Illness Prevention Individuals or Households 3600 43200 0

Format labeling in accordance with 201.66(c) and (d) for new sunscreen SKUs No Health Illness Prevention Individuals or Households 60 720 0

2012-08-15-04:00

0910-0718 201206-0910-008 0910
             
        "Biosimilar User Fee Cover Sheet - Form FDA 3792"
             
          
        
Proposed Form FDA 3792, the Biosimilar User Fee Cover Sheet, requests the minimum necessary information to determine the amount of the fee required, and to account for and track user fees. The form would provide a cross-reference of the fees submitted for a submission with the actual submission by using a unique number tracking system. The information collected would be used by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to initiate the administrative screening of biosimilar biological product INDs, applications, and supplements, and to account for and track user fees associated with BPD meetings, biosimilar biological product INDs, applications, and supplements. 2015-08-31-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 9 5 0

Form FDA 3792 No Health Illness Prevention Private Sector 9 5 0

2012-08-15-04:00

0910-0719 201206-0910-004 0910
             
        "General Licensing Provisions; Section 351(k) Biosimilar Applications"
             
          
        
The information collection establishes an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product, and sets forth the requirements for an application for a proposed biosimilar product and an application or a supplement for a proposed interchangeable product. 2015-08-31-04:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 5 2584 0

Application for Biosimilars - 351(k)(2)(A)(i) and (k)(2)(A)(iii) No Health Illness Prevention Private Sector 2 1720 0

Application for Biosimilars - 351(k)(2)(B) and (k)(4) No Health Illness Prevention Private Sector 1 860 0

Application for Biosimilars - 351(l)(6)(C) No Health Illness Prevention Private Sector 2 4 0

2012-08-15-04:00

0910-0720 201309-0910-013 0910
             
        "Unique Device Identification System"
             
          
        
FDA is issuing regulations establishing a unique device identification system for medical devices. The recordkeeping, reporting, and third-party disclosure requirements referenced in the UDI regulation are imposed on any person who causes a label to be applied to a device, or who causes the label to be modified, with the intent that the device will be introduced into interstate commerce without any subsequent replacement or modification of the label. In most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler. This rule is intended to substantially reduce existing obstacles to the adequate identification of medical devices used in the United States. By making it possible to rapidly and definitively identify a device and key attributes that affect its safe and effective use, the rule would reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use. 2016-12-31-05:00 Active JonnaLynn Capezzuto jonnalynn.capezzuto@fda.hhs.gov 301 827-4659 No No No 1830553 802821 0

Reporting (first year) No Health Immunization Management Private Sector 12646 887 0

Recordkeeping (first year) No Health Immunization Management Private Sector 45217 3685 0

Third-Party Disclosure (UDI) No Health Immunization Management Private Sector 635101 7930 0

Third-Party Disclosure (Date Format) No Health Immunization Management Private Sector 210766 210766 0

Reporting (ongoing) No Health Immunization Management Private Sector 316149 7289 0

Recordkeeping (ongoing) No Health Immunization Management Private Sector 305337 302121 0

Third-Party Disclosure (ongoing) No Health Immunization Management Private Sector 305337 270143 0

2013-12-02-05:00

0910-0721 201205-0910-006 0910
             
        "Animal Food Labeling; Declaration of Certifiable Color Additives"
             
          
        
Under the provisions of the Nutrition Labeling and Education Act (the 1990 amendments), producers are required, among other things, to list on food labels all of the common or usual names of all color additves required to be certified by FDA. 2015-08-31-04:00 Active Denver Presley 3018271462 No No No 15458 3865 4608153

Third Party Disclosure - 21 CFR 501.22(k)(1) No Health Consumer Health and Safety Private Sector 15008 3752 3100653

Third Party Disclosure - 21 CFR 501.22(k)(2) No Health Consumer Health and Safety Private Sector 450 113 1507500

2012-08-27-04:00

0910-0722 201207-0910-002 0910
             
        "Medical Device Decision Analysis: A Risk-Tolerance Pilot Study"
             
          
        
The purpose of this pilot study is to summarize patient preferences and willingness to accept tradeoffs among attributes of medical interventions. The pilot study will help FDA evaluate the feasibility and validity of this approach for providing evidence about patients' preferences and risk tolerance. Specifically, the weight-reduction device case study will elicit trade-off preferences of subjects with self-reported BMI of 30 kg/m2 or above for the most salient features or attributes of weight reduction medical devices. The pilot study information will be used by the FDA to evaluate stated-preference methods as a possible source of evidence about patients' benefit-risk trade-off preferences for devices. FDA's Center for Devices and Radiological Health (CDRH) is evaluating processes to incorporate patient preferences on treatment benefits and risks in its device review process. To obtain such preferences in a systematic and scientifically valid way, CDRH has commissioned this survey to be administered to members of a web panel that is representative of the U.S. population. 2014-08-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 2150 240 0

Survey Invitation No Health Immunization Management Individuals or Households 1000 30 0

Consent Form No Health Immunization Management Individuals or Households 700 21 0

Full Survey No Health Immunization Management Individuals or Households 450 189 0

2012-08-31-04:00

0910-0723 201205-0910-003 0910
             
        "Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma"
             
          
        
FDA is finalizing the labeling requirements for blood or blood components intended for use in transfusion or for further manufacture pursuant to the provisions of the Public Health Service Act (PHS Act) (42 U.S.C. 262-264), and the drugs, devices, and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351-353, 355, 360, 360j, 371, and 374). Under these provisions of the PHS Act and the Federal Food, Drug, and Cosmetic Act, we have the authority to issue and enforce regulations designed to ensure that biological products are safe, pure, potent, and properly labeled, and to prevent the introduction, transmission, and spread of communicable disease. 2015-04-30-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 1 1 0

Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma No Health Consumer Health and Safety Private Sector 1 1 0

2012-09-14-04:00

0910-0724 201211-0910-008 0910
             
        "Experimental Study: Disease Information in Branded Promotional Material"
             
          
        
This project will investigate the effects of adding disease information to branded prescription drug promotional materials on consumer perceptions and understanding. Part of FDA's public health mission is to ensure the safe use of prescription drugs; therefore it is important to communicate the risks and benefits of prescription drugs to consumers in a way that is clear, useful and non-misleading. The results from this project will be used by FDA to inform its understanding of DTC advertising, inform regulatory policy, and may also help to identify areas for further research. 2015-11-30-05:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 14338 1873 0

Number of Completes - Screener No Health Illness Prevention Private Sector 9688 323 0

Number of Completes - Pretests No Health Illness Prevention Private Sector 900 300 0

Number of Completes - Study No Health Illness Prevention Private Sector 3750 1250 0

2012-11-27-05:00

0910-0725 201209-0910-002 0910
             
        "Experimental Study; Health Claims and Disclaimers About the Relationship Between Selenium and Risk of Various Cancers"
             
          
        
The need for this collection of information derives from the Food and Drug Administration's (FDA's) regulation of the labeling of food products under the Federal Food, Drug, and Cosmetic Act, as amended by the Nutrition Labeling and Education Act of 1990 (NLEA). NLEA regulations establish general requirements for voluntary health claims, i.e., statements in food labeling that characterize the relationship between a food substance and a disease or health-related condition (21 CFR 101.14(a)(1)). Under the petition process for new health claims (21 CFR 101.70), petitioners must submit scientific evidence supporting a proposed health claim to FDA for review. If FDA determines that there is significant scientific agreement (SSA) among experts that the proposed health claim is supported by the totality of publicly available evidence, FDA issues a regulation authorizing the claim (21 CFR 101.14(c)-(d)). Prior research has not investigated how consumers interpret labeling claims using phrases such as "certain cancers" and "anticarcinogenic effects," or whether qualifiers, such as a listing of site-specific cancers, would eliminate potential deception. The agency therefore proposes an experimental study to examine consumer reactions to health claims using those phrases, with and without various disclaimers. The objective of this proposed study is to collect quantitative data to examine consumer interpretations of two dietary supplement labeling claims, "selenium may reduce the risk of certain cancers" and "selenium may produce anticarcinogenic effects in the body," with and without various disclaimers. 2014-07-31-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 48319 1789 0

Cognitive Interview Screener No Health Consumer Health and Safety Individuals or Households 350 29 0

Cognitive Intervew No Health Consumer Health and Safety Individuals or Households 9 9 0

Pretest Invitation No Health Consumer Health and Safety Individuals or Households 1700 56 0

Pretest No Health Consumer Health and Safety Individuals or Households 60 10 0

Survey Invitation No Health Consumer Health and Safety Individuals or Households 45000 1485 0

Survey No Health Consumer Health and Safety Individuals or Households 1200 200 0

2012-12-20-05:00

0910-0726 201206-0910-001 0910
             
        "Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities"
             
          
        
The information gathered from this survey will be used to initiate the development of strategies for implementing various provisions of the Food Safety Modernization Act, specifically section 205(c)1. This survey will serve as an assessment to guide future work and discussions amongst Federal, State, and local government agencies with responsibility for food safety and public health. This assessment will allow FDA to better understand the current capacities and procedural systems of State and local agencies which will allow FDA to operate more efficiently and effectively with its partners. 2015-12-31-05:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 1391 1391 0

Survey Study -- Current State and Local Government Agencies No Health Public Health Monitoring State, Local, and Tribal Governments 1391 1391 0

2012-12-21-05:00

0910-0727 201211-0910-004 0910
             
        "Generic Drug User Fee Cover Sheet - Form FDA 3794"
             
          
        
Proposed Form FDA 3794, the Generic Drug User Fee Amendments Cover Sheet, requests the minimum necessary information from applicants to determine the total amount of generic drug user fees required, and to account for and track user fees. The information collected would be used by the FDA's Center for Drug Evaluation and Research to initiate the administrative screening of generic drug submissions and drug master files, support the inspection of generic drug facilities, and otherwise support the generic drug program. 2015-12-31-05:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 3850 1925 0

Generic Drug User Fee Cover Sheet - Form FDA 3794 No Health Consumer Health and Safety
FDA 3794 Generic Drug User Fee Cover Sheet Yes Yes Fillable Fileable Form and instruction GDUFA Cover Sheet REVISED 10-15-12.pdf
Private Sector 3850 1925 0

2012-12-27-05:00

0910-0728 201209-0910-001 0910
             
        "Labeling of Certain Beers Subject to the Labeling Jurisdiction of the FDA"
             
          
        
The Alcohol and Tobacco Tax and Trade Bureau (TTB) (formerly the Bureau of Alcohol, Tobacco, and Firearms (ATF)) has clarified that certain beers, which are not made from both malted barley and hops, but are instead made from substitutes for malted barley (such as sorghum, rice or wheat) or are made without hops, do not meet the definition of a malt beverage under the Federal Alcohol Administration Act (FAA Act). TTB stated, therefore, in its ruling that such products (other than sake, which is classified as a wine under the FAA Act) are not subject to the labeling, advertising, and other provisions of the TTB regulations promulgated under the FAA Act. Because these beers are not subject to the labeling provisions of the FAA Act, they are subject to the labeling provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). 2016-01-31-05:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 156 186 0

Beer Labeling under 21 CFR 101.3 and 101.22 No Health Consumer Health and Safety Private Sector 24 12 0

Beer Labeling under 21 CFR 101.4 No Health Consumer Health and Safety Private Sector 24 24 0

Beer Labeling under 21 CFR 101.5 No Health Consumer Health and Safety Private Sector 24 6 0

Beer Labeling under 21 CFR 101.9 No Health Consumer Health and Safety Private Sector 24 96 0

Beer Labeling under 21 CFR 101.105 No Health Consumer Health and Safety Private Sector 24 12 0

Beer Labeling under sec. 403(w)(1) of the FFDCA No Health Consumer Health and Safety Private Sector 24 24 0

Beer Labeling Guidance No Health Consumer Health and Safety Private Sector 12 12 0

2013-01-14-05:00

0910-0729 201206-0910-014 0910
             
        "Secure Supply Chain Pilot Program (SSCPP)"
             
          
        
The Secure Supply Chain Pilot Program (SSCPP) is intended to assist FDA in its efforts to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the Agency to focus its resources on imported drugs that fall outside the program and that may pose such risks. Such a program would increase the likelihood of expedited entry for specific finished drug products and APIs imported into the United States that meet the criteria for selection under the program. 2016-02-29-05:00 Active Johnny Vilela juanmanuel.vilela@fda.hhs.gov 301 796-3792 No No No 26506 27756 0

Secure Supply Chain Application Form No Health Immunization Management Private Sector 500 1750 0

Modified Secure Supply Chain Application Form No Health Immunization Management Private Sector 5 5 0

Information Submitted In Response To Termination Of Participation No Health Immunization Management Private Sector 1 1 0

Secure Supply Chain Pilot Program Records - Recordkeeping No Health Immunization Management Private Sector 26000 26000 0

2013-02-04-05:00

0910-0730 201210-0910-001 0910
             
        "Health Care Professional Survey of Prescription Drug Promotion"
             
          
        
The present study aims to investigate the perspectives of health care professionals with prescribing privileges--including physicians, physician assistants, and nurse practitioners--regarding various aspects of prescription drug promotion. Specifically, the survey will address DTC advertising, professional promotion, use of new technologies including social media, and the Office of Prescription Drug Promotion's (OPDP's) Bad Ad program. This is the first such study to our knowledge that examines the beliefs of health care professionals other than physicians who now have prescribing privileges. The study findings will inform FDA of relevant issues and concerns relating to health care professional exposure to prescription drug promotion. 2016-02-29-05:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 7550 773 0

Informed Consent No Health Consumer Health and Safety Private Sector 2025 60 0

Pretest No Health Consumer Health and Safety Private Sector 25 8 0

Main Study No Health Consumer Health and Safety Private Sector 2000 600 0

Screener No Health Consumer Health and Safety Private Sector 3500 105 0

2013-02-08-05:00

0910-0731 201212-0910-010 0910
             
        "GUIDANCE ON MEETINGS WITH INDUSTRY AND INVESTIGATORS ON THE RESEARCH AND DEVELOPMENT OF TOBACCO PRODUCTS "
             
          
        
The information collection in this guidance is intended to assist tobacco manufacturers, importers, researchers, and investigators, and their representatives who seek meetings with staff of FDA's Center for Tobacco Products (CTP) relating to their plans to conduct research to inform the regulation of tobacco products or support the development or marketing of tobacco products. This guidance does not pertain to other types of meetings or meeting requests with CTP staff. The information collected will help FDA better understand issues discussed during these meetings. The Tobacco Control Act (Pub. L. 111-31) offers tobacco product manufacturers several pathways to obtain an order from FDA to authorize the marketing of a tobacco product before it may be introduced or delivered into interstate commerce. To provide assistance with these pathways to market particular products, FDA offers to meet with tobacco product manufacturers, importers, researchers, and investigators (or their representatives) where appropriate. This guidance assists persons wishing to meet with FDA regarding their research to inform the regulation of tobacco products, or to support the development or marketing of tobacco products. 2016-02-29-05:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 67 1876 0

GUIDANCE ON MEETINGS WITH INDUSTRY AND INVESTIGATORS ON THE RESEARCH AND DEVELOPMENT OF TOBACCO PRODUCTS No Health Public Health Monitoring Private Sector 67 1876 0

2013-02-13-05:00

0910-0732 201208-0910-001 0910
             
        "Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act"
             
          
        
This collection requires each tobacco product manufacturer or importer, or an agent, to report to FDA "all constituents, including smoke constituents, identified by [FDA] as harmful or potentially harmful to health in each tobacco product, and as applicable in the smoke of each tobacco product." These entities must also provide similar information at least 90 days prior to introducing the product into interstate commerce. 2016-03-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 1896 88434 0

Reporting of Harmful and Potentially Harmful Constituents (in Accordance with Sections 904(a)(3) and 904(c)(1) of the Federal Food, Drug, and Cosmetic Act) No Health Immunization Management
Yes Yes Fillable Fileable Other Yes Yes Fillable Printable Other FDAA 3787a Reporting of Harmful and Potentially Harmful Constituents Cigarette Report Yes Yes Paper Only Form and instruction Yes Yes Fillable Printable Other Yes Yes Fillable Printable Other Yes Yes Fillable Printable Other Yes Yes Paper Only Instruction Yes Yes Paper Only Other a Cigarette Report Form FDA 3787a Yes Yes Fillable Printable Form and instruction b Smokeless Tobacco Product Report Form FDA 3787b Yes Yes Fillable Printable Form and instruction c Roll-Your-Own -RYO- Tobacco Product Report Form FDA 3787c Yes Yes Fillable Printable Form and instruction Yes Yes Paper Only Other
Private Sector 1212 71145 0

Annual Cigarette Report - Reporting of Harmful and Potentially Harmful Constituends No Health Immunization Management
Yes Yes Fillable Printable Other c Roll-Your-Own -RYO- Tobacco Product Report Form FDA 3787c Yes Yes Fillable Printable Form and instruction b Smokeless Tobacco Product Report Form FDA 3787b Yes Yes Fillable Printable Form and instruction a Cigarette Report Form FDA 3787a Yes Yes Paper Only Form and instruction
Private Sector 182 10682 0

One Time Smokeless Report - Reporting of Harmful and Potentially Harmful Constituents No Health Immunization Management
b Smokeless Tobacco Product Report Form FDA 3787b Yes Yes Fillable Printable Form and instruction c Roll-Your-Own -RYO- Tobacco Product Report Form FDA 3787c Yes Yes Fillable Printable Form and instruction a Cigarette Report Form FDA 3787a Yes Yes Fillable Printable Form and instruction Yes Yes Paper Only Other
Private Sector 288 4049 0

Annual Smokeless Product Report - Reporting of Harmful and Potentially Harmful Constituents No Health Immunization Management
a Cigarette Report Form FDA 3787a Yes Yes Fillable Printable Form and instruction Yes Yes Paper Only Other c Roll-Your-Own -RYO- Tobacco Product Report Form FDA 3787c Yes Yes Fillable Printable Form and instruction b Smokeless Tobacco Product Report Form FDA 3787b Yes Yes Fillable Printable Form and instruction
Private Sector 43 605 0

One Time Roll Your Own Tobacco Product Report - Reporting of Harmful and Potential Harmful Constituents No Health Immunization Management
b Smokeless Tobacco Product Report Form FDA 3787b Yes Yes Fillable Printable Form and instruction a Cigarette Report Form FDA 3787a Yes Yes Fillable Printable Form and instruction c Roll-Your-Own -RYO- Tobacco Product Report Form FDA 3787c Yes Yes Fillable Printable Form and instruction Yes Yes Paper Only Other
Private Sector 148 1690 0

Annual Roll Your Own Tobacco Product Report - Reporting of Harmful and Potentially Harmful Constituents No Health Immunization Management
Yes Yes Paper Only Other c Roll-Your-Own -RYO- Tobacco Product Report Form FDA 3787c Yes Yes Fillable Printable Form and instruction b Smokeless Tobacco Product Report Form FDA 3787b Yes Yes Fillable Printable Form and instruction a Cigarette Report Form FDA 3787a Yes Yes Fillable Printable Form and instruction
Private Sector 23 263 0

2013-03-15-04:00

0910-0733 201210-0910-002 0910
             
        "Final Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring; Availability"
             
          
        
The guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof. The guidance makes clear that sponsors can use a variety of approaches to fulfill their responsibilities for monitoring investigator conduct and performance in investigational new drug (IND) studies conducted under 21 CFR part 312 or investigational device exemption (IDE) studies conducted under 21 CFR part 812. The guidance describes strategies for monitoring activities performed by a sponsor, or contract research organizations (CROs), that focus on the conduct, oversight, and reporting of findings of an investigation by clinical investigators. The guidance recommends strategies that reflect a risk-based approach to monitoring that focuses on critical study parameters and relies on a combination of monitoring activities to oversee a study effectively. For example, the guidance specifically encourages greater reliance on centralized monitoring methods, where appropriate. 2016-03-31-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 132 528 0

Development of Comprehensive Monitoring Plan No Health Consumer Health and Safety Private Sector 132 528 0

2013-03-20-04:00

0910-0734 201211-0910-007 0910
             
        "Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act"
             
          
        
The guidance provides information on the implementation of the new statutory provisions, including a description of the types of safety labeling changes that ordinarily might be required under the new legislation; how the Food and Drug Administration plans to determine what constitutes new safety information; the procedures involved in requiring safety labeling changes; and enforcement of the requirements for safety labeling changed. 2016-03-31-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 203 824 0

Guidance for Industry on Safety Labeling Changes; Implementation of Section 505(o)(4) of the FD&C Act-- Rebuttal Statement No Health Consumer Health and Safety Private Sector 6 36 0

Guidance for Industry on Safety Labeling Changes; Post Approved Labeling on Application Holder's Web site No Health Consumer Health and Safety Private Sector 197 788 0

2013-03-20-04:00

0910-0735 201205-0910-001 0910
             
        "Experimental Study on Consumer Responses to Labeling Statements on Food Packages"
             
          
        
Research suggests consumer product perceptions and purchase decisions can be influenced by labeling statements and different labeling statements may have different influences (Refs. 9-12). Therefore, the FDA, as part of its effort to promote public health, proposes to use this study to explore consumer responses to food labels that bear multiple labeling statements. Specifically, the study plans to examine: (1) consumer responses to food labels that exhibit various combinations of the number and type of statements; (2) whether and how consumer responses to one label characteristic may be affected by the other characteristic (i.e., the interactions between different characteristics of labeling statements); and (3) whether and how labeling statements affect the use of the Nutrition Facts label. 2016-03-31-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 37881 2174 0

Cognitive Interview Screener Invitation No Health Consumer Health and Safety Private Sector 72 6 0

Cognitive Interview No Health Consumer Health and Safety Private Sector 9 9 0

Pretest Invitation No Health Consumer Health and Safety Private Sector 1600 53 0

Pretest No Health Consumer Health and Safety Private Sector 200 50 0

Survey Invitation No Health Consumer Health and Safety Private Sector 32000 1056 0

Survey No Health Consumer Health and Safety Private Sector 4000 1000 0

2013-03-21-04:00

0910-0736 201301-0910-004 0910
             
        "Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents"
             
          
        
The purpose of this submission is to request OMB approval to conduct an experimental study to help inform FDA decisions about how to implement section 904(d)(1) of the Food Drug & Cosmetic Act (FD&C Act or the Act) and to provide information about how consumers understand information about Harmful and Potentially Harmful Constituents (HPHCs) in tobacco products. 2016-03-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 13210 1772 0

Pre Test No Health Public Health Monitoring Individuals or Households 60 30 0

Screener No Health Public Health Monitoring Individuals or Households 10000 167 0

Experimental Survey No Health Public Health Monitoring Individuals or Households 3150 1575 0

2013-03-22-04:00

0910-0737 201301-0910-002 0910
             
        "Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising"
             
          
        
FDA regulations require prescription drug ads to contain accurate information about the benefits and risks of the drug advertised. When this is not the case, corrective advertising is designed to dissipate or correct erroneous beliefs resulting from a false claim. Corrective advertising is one remedy FDA may request in response to false or misleading prescription drug promotion. The current project will examine the influence of corrective messages in the realm of consumer directed prescription drug advertising. The study will investigate how variations in corrective advertising may influence consumers' product beliefs. Specifically, the study will focus on the following variables of interest: (1) exposure to corrective, (2) visual similarity between the original and corrective ads, and (3) time delay between the original and corrective ads. The study findings will inform FDA of relevant consumer issues relating to corrective DTC advertising. 2016-03-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 21541 5496 0

Screener completes No Health Immunization Management Individuals or Households 14891 496 0

Pretest (stimuli) completes No Health Immunization Management Individuals or Households 1450 483 0

Pretest (questionnaire) completes No Health Immunization Management Individuals or Households 200 100 0

Phase 1 completes No Health Immunization Management Individuals or Households 1000 417 0

Phase 2 completes No Health Immunization Management Individuals or Households 4000 4000 0

2013-03-25-04:00

0910-0738 201303-0910-003 0910
             
        "Guidance for Center for Devices and Radiological Health Appeals Processes"
             
          
        
This guidance document describes the processes available to outside stakeholders to request additional review of decisions or actions by Center for Devices and Radiological Health (CDRH or the Center) employees. The Food and Drug Administration (FDA) is seeking approval for the new reporting burden associated with requests for additional review of decisions and actions by CDRH employees as described in this guidance. Individuals outside of FDA who disagree with a decision or action taken by CDRH employees and wish to have it reviewed or reconsidered have several processes for resolution from which to choose, including: requests for supervisory review of an action, petitions, and hearings. Of these, by far the most commonly used is a request for supervisory review under 21 CFR 10.75 (a "10.75 appeal"). Section 517A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 603 of the FDA Safety and Innovation Act of 2012, includes new requirements pertaining to the process and timelines for 10.75 appeals of "significant decisions" regarding 510(k) premarket notifications, applications for premarket approvals (PMAs), and applications for investigational device exemptions (IDEs). In this guidance document, the term "significant decision" will refer to significant decisions pertaining to these submissions. 2016-04-30-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 50 400 0

CDRH Appeals Processes Guidance Document No Health Immunization Management Private Sector 50 400 0

2013-04-23-04:00

0910-0743 201305-0910-005 0910
             
        "Communicating Composite Scores in Direct-to-Consumer (DTC) Prescription Drug Advertising "
             
          
        
The main goal of the current research is to evaluate how consumers interpret and respond to DTC prescription drug advertising that includes benefit information based on composite scores. Specifically, this research will explore: 1. Whether consumers are aware of how efficacy is measured for specific drugs; 2. How well consumers comprehend the concept of composite scores; 3. Whether exposure to DTC advertisements with composite scores influences consumers' perceptions of a drug's efficacy and risk; and 4. Different methods for presenting composite scores in DTC ads to maximize consumer comprehension and informed decision-making. 2016-07-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 8004 1321 0

Study Phase 1 Informed Consent No Health Immunization Management Individuals or Households 1800 54 0

Study Phase 1 Pretest No Health Immunization Management Individuals or Households 200 60 0

Study Phase 1 Main Study No Health Immunization Management Individuals or Households 1600 480 0

Study Phase 2 Informed Consent No Health Immunization Management Individuals or Households 2202 66 0

Study Phase 2 Pretest No Health Immunization Management Individuals or Households 462 139 0

Study Phase 2 Main Study No Health Immunization Management Individuals or Households 1740 522 0

2013-07-26-04:00

0910-0744 201211-0910-005 0910
             
        "Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types (2013)"
             
          
        
The Food and Drug Administration (FDA) is proposing a voluntary survey to measure trends in the occurrence of foodborne illness risk factors in nine select retail and foodservice facility types. The data will be used to determine the following: foodborne illness risk factors that are in most need of priority attention during each data collection period; trends of improvement or regression in foodborne illness risk factor occurrence over time; potential correlations between operational aspects of the industry; potential correlations between elements within regulatory retail food protection programs; and the impact of industry food safety management systems in controlling the occurrence of foodborne illness risk factors. 2015-08-31-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 1810 1767 0

FY13 Pilot amp;#8211; Completion of Sections 1 and 3 amp;#8211; Fast Food Facility Type No Health Health Care Services Private Sector 44 53 0

FY13 Pilot amp;#8211; Completion of Sections 1 and 3 amp;#8211; Full Service Facility Type No Health Health Care Services Private Sector 44 77 0

FY13 Pilot amp;#8211; Completion of Section 2 amp;#8211; All Facility Types No Health Health Care Services Private Sector 88 44 0

FY13 Pilot amp;#8211; Entry Refusals amp;#8211; All Facility Types No Health Health Care Services Private Sector 2 2 0

FY14 Baseline Data Collection (Fast Food Restaurants) amp;#8211; Completion of Sections 1 and 3 No Health Health Care Services Private Sector 400 484 0

FY14 Baseline Data Collection (Full Service Restaurants) amp;#8211; Completion of Sections 1 and 3 No Health Health Care Services Private Sector 400 704 0

FY14 Baseline Data Collection amp;#8211; Completion of Section 2 amp;#8211; All Facility Types No Health Health Care Services Private Sector 800 400 0

FY14 Baseline Data Collection Entry Refusals amp;#8211; All Facility Types No Health Health Care Services Private Sector 32 3 0

2013-08-06-04:00

0910-0745 201303-0910-009 0910
             
        "Guidance for Industry on Tobacco Retailer Training Programs"
             
          
        
The Tobacco Control Act provides for lower civil money penalties for violations of sale and distribution, including youth access, and advertising and promotions restrictions issued under section 906(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, for retailers who have implemented a training program that complies with standards developed by FDA for such programs (section 103(q)(2) of the Tobacco Control Act). FDA intends to promulgate regulations establishing standards for approved retailer training programs. Until FDA promulgates these regulations, the agency intends to use the lower maximum civil money penalties schedule for all retailers who violate the restriction of the sale and distribution of cigarettes and smokeless tobacco products, whether or not they have implemented a training program. However, FDA may consider further reducing the civil money penalty for retailers who have implemented an approved training program. In the interim, the guidance document associated with this collection of information is intended to assist tobacco retailers in implementing training programs for employees. 2016-08-31-04:00 Active Daniel Gitteson daniel.gitteson@fda.hhs.gov 3017965156 No No No 270600 3042740 0

Tobacco Retailer Training Program No Health Immunization Management Private Sector 270600 3042740 0

2013-08-12-04:00

0910-0746 201305-0910-002 0910
             
        "Evaluation of the Program for Enhanced Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs in Prescription Drug User Fee Act"
             
          
        
This information collection involves interviews of pharmaceutical manufacturers who submit new molecular entity (NME) new drug application(NDAs) and original biologics license applications (BLAs) to the Food and Drug Administration (FDA) under the Program for Enhanced Review Transparency and Communication ("the Program") during fiscal years (FYs) 2013-2017. The Program is part of the FDA performance committments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA) that allows FDA to collect user fees for the review of human drug and biologics applications for FYs 2013-2017. The Program is described in detail in Section II.B of the document entitled "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017" (the "Commitment Letter). This document specifies that the Program must be evaluated in interim and final assessments by an independent contractor and that these assessments must include interviews of sponsors who submit NME NDAs and original BLAs that are reviewed under the Program. The purpose of these interviews is to collect feedback from applicants on the success of the Program in promoting review transparency and communication during the review process. 2016-08-31-04:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 140 211 0

Pretest No Health Consumer Health and Safety Private Sector 5 8 0

Interviews No Health Consumer Health and Safety Private Sector 135 203 0

2013-08-14-04:00

0910-0747 201211-0910-006 0910
             
        "Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages"
             
          
        
FDA conducts research and educational and public information programs relating to food safety pursuant to its broad statutory authority, set forth in section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 393 (b)(2), to protect the public health by ensuring that foods are "safe, wholesome, sanitary, and properly labeled," and in section 903(d)(2)(C) (21 U.S.C. 393 (d)(2)(C)), to conduct research relating to foods, drugs, cosmetics and devices in carrying out the act. FDA helps consumers make informed dietary decisions by regulating nutrition information in food labeling, initiating its own consumer education activities, and collaborating with public and private entities in conveying nutrition information to consumers. These activities are aimed at influencing consumer awareness, understanding, and behaviors related to diet and nutrition and ultimately health outcomes of the Nation. The Nutrition Labeling and Education Act (NLEA), which amended the Food, Drug and Cosmetic Act, requires most foods to bear nutrition labeling and requires food labels that bear nutrient content claims and certain health messages to comply with specific requirements. There are three different types of claims that the food industry can voluntarily use on food labels. Although they are regulated differently, they all must be truthful and not misleading. FDA is proposing to conduct an experimental study to quantitatively assess consumer reactions to different whole grain statements. The purpose of the study is to help enhance FDA's understanding of consumer comprehension and perceptions of food labels that use whole grains labeling statements. The study is part of the agency's continuing effort to enable consumers to make informed dietary choices and construct healthful diets. The results of the study will be used for informing possible measures that the agency may take to help consumers make such choices. 2015-09-30-04:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 9909 1050 0

Cognitive Interview Screener No Health Consumer Health and Safety Individuals or Households 72 6 0

Cognitive Interview No Health Consumer Health and Safety Individuals or Households 9 9 0

Pretest Invitation No Health Consumer Health and Safety Individuals or Households 1152 38 0

Pretest No Health Consumer Health and Safety Individuals or Households 576 144 0

Survey Invitation No Health Consumer Health and Safety Individuals or Households 5400 178 0

Survey No Health Consumer Health and Safety Individuals or Households 2700 675 0

2013-09-05-04:00

0910-0753 201402-0910-002 0910
             
        "Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign"
             
          
        
The Food and Drug Administration (FDA) requests Office of Management and Budget (OMB) approval to conduct in-person and Web-based surveys of youth in targeted areas in the United States. These surveys will be fielded for purposes of evaluating FDA's general market youth tobacco prevention campaigns. The primary outcome evaluation will consist of an initial baseline survey before the launch of each of three campaigns and three longitudinal follow-up surveys of those participants in 8-month intervals following the baseline data collection. In addition, a tracking survey to assess awareness of the campaigns and receptivity to campaign messages will occur in 8-month intervals throughout the data collection period. As part of the outcome evaluation study, a baseline survey will also be conducted with the parent or legal guardian of each youth baseline survey participant in order to collect data on household characteristics and media use. Data from this evaluation will be used to gauge campaign awareness and examine the statistical relationships between exposure to the campaigns and changes in outcome variables of interest. 2016-10-31-04:00 Active JonnaLynn Capezzuto jonnalynn.capezzuto@fda.hhs.gov 301 827-4659 No No No 70618 12612 0

General Population Screener and Consent Process (Youth and Parent) No Health Public Health Monitoring Individuals or Households 13413 2280 0

Youth Baseline Questionnaire (Experimenter and Non-Trier) No Health Immunization Management Individuals or Households 2686 1343 0

Youth 1st, 2nd, 3rd Follow-Up Questionnaire (Experimenter and Non-Trier) No Health Immunization Management Individuals or Households 5242 3931 0

Youth Baseline Questionnaire (Male Rural Smokeless) No Health Immunization Management Individuals or Households 656 328 0

Youth 1st, 2nd, amp; 3rd (Male, Rural Smokeless) fullow up questionnaire No Health Immunization Management Individuals or Households 1281 961 0

Parent Of Youth Baseline Survey Participants No Health Immunization Management Individuals or Households 3342 568 0

Media Tracking Screener No Health Immunization Management Individuals or Households 39999 1200 0

Media Tracking Questionnaires 1st, 2nd amp; 3rd No Health Immunization Management Individuals or Households 3999 2001 0

2014-02-07-05:00

0910-0754 201309-0910-005 0910
             
        "Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information"
             
          
        
This information collection request estimates the third-party disclosure burden for preparing letters of important new information about prescription drug and biological products (drugs). These letters communicate new information promptly to health care practitioners involved in prescribing or dispensing a drug, or in caring for patients who receive a drug. 2016-12-31-05:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 30 3000 0

Mailing of Important Information About Drugs - 21 CFR 200.5 No Health Consumer Health and Safety Private Sector 30 3000 0

2013-12-13-05:00

0910-0755 201307-0910-006 0910
             
        "Protection of Human Subjects: Informed Consent; Institutional Review Boards"
             
          
        
This information collection request addresses limited collections of information not currently approved under an OMB control number for institutional review boards (IRBs) and clinical investigators involved with human subject research regulated by the Food and Drug Administration (FDA). IRBs are required to review for approval FDA-regulated research activities. Clinical investigators are required to obtain informed consent from research subjects participating in FDA-regulated clinical trials. These limited collections of information help protect the rights, safety, and welfare of human subjects who participate in research actitivies within FDA's jurisdiction. 2016-12-31-05:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 246021 243070 0

IRB Written Notification to Approve or Disapprove Research, 56.109(e); Continuing Review, 56.109(f); Elements of Informed Consent (IC), 50.25; Documentation of IC, 50.27 No Health Consumer Health and Safety Private Sector 240000 240000 0

Exception from Informed Consent for Emergency Research, 50.24 No Health Consumer Health and Safety Private Sector 15 15 0

Suspension of Termination of IRB Approval of Research, 56.113 No Health Consumer Health and Safety Private Sector 6000 3000 0

IRB Response to Lesser Administrative Actions for Noncompliance, 56.120(a) No Health Consumer Health and Safety Private Sector 5 50 0

Reinstatement of an IRB or Institution, 56.123 No Health Consumer Health and Safety Private Sector 1 5 0

2013-12-13-05:00

0910-0756 201311-0910-002 0910
             
        "Requests for Feedback on Medical Device Submissions"
             
          
        
The final guidance establishes such a structured process for submission and management of Pre-Submissions and supports the procedures that CDRH and CBER intend to follow when manufacturers, their representatives, or application sponsors submit a request for feedback on a medical device submission, including when the preferred method of feedback is a meeting with review staff. The guidance also provides recommendations regarding how to prepare for meetings with FDA staff. These voluntary information collection requirements support a structured process with clear recommendations for sponsors who submit a pre-submission feedback request and for FDA staff and managers involved in their review, as well as expected timeframes for scheduling meetings. 2016-12-31-05:00 Active JonnaLynn Capezzuto jonnalynn.capezzuto@fda.hhs.gov 301 827-4659 No No No 2544 348528 0

CDRH Presubmissions No Health Immunization Management Private Sector 2465 337705 0

CBER Presubmissions No Health Immunization Management Private Sector 79 10823 0

2013-12-24-05:00

0910-0758 201311-0910-001 0910
             
        "Final Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes to be Documented in Annual Reports"
             
          
        
The information collection pertains to the types of CMC postapproval manufacturing changes that FDA has determined will likely have a minimal potential to have an adverse effect on product quality (i.e., drug product identity, strength, quality, purity, or potency), and therefore, should be documented by applicants in an annual report under 21 CFR 314.70(d). 2017-01-31-05:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 2876 286150 0

Supplements and Annual Reports for New Drug Applications No Health Consumer Health and Safety Private Sector 801 120150 0

Supplements and Annual Reports for Abbreviated New Drug Applications No Health Consumer Health and Safety Private Sector 2075 166000 0

2014-01-27-05:00

0910-0760 201312-0910-002 0910
             
        "Animal Feed Regulatory Program Standards"
             
          
        
This information collection request collects information from State feed programs who voluntarily decide to implement the Animal Feed Regulatory Program Standards (hereafter know as feed standards). Respondents submit information as provided in the feed standards. The Food and Drug Administration has developed forms to facilitate its review of information being submitted so that the implementation status of each of the 11 standards can be determined. 2017-01-31-05:00 Active ILa Mizrachi ila.mizrachi@fda.hhs.gov 301 796-7726 No No No 50 150000 0

State Feed Regulatory Programs in the United States No Health Consumer Health and Safety Private Sector 50 150000 0

2014-01-30-05:00

0910-0761 201307-0910-003 0910
             
        "Eye Tracking Experimental Studies to Explore Consumer Use of Food Labeling Information and Consumer Response to Online Surveys"
             
          
        
This data collection is designed to assist the agency in developing labeling information to help consumers make informed dietary decisions. Two independent studies using state-of-the-art eye-tracking equipment and techniques will collect data on how consumers view and use labeling information Study 1 is an experimental study in which 200 consumers at four different geographical locations will view a series of label images on a computer screen and be asked to (1) choose between two products, (2) rate the nutrition characteristics of a single product, or (3) calculate intakes of selected nutrients. Study 2 is an observational study in which 60 grocery shoppers at two different geographical locations will be asked to shop as they would normally do, and will be conducted in real stores. 2016-01-31-05:00 Active Domini Bean domini.bean@fda.hhs.gov 301 796-5733 No No No 1105 170 0

Laboratory pretest invitation No Health Consumer Health and Safety Individuals or Households 30 1 0

Laboratory pretest No Health Consumer Health and Safety Individuals or Households 15 15 0

Laboratory study invitation No Health Consumer Health and Safety Individuals or Households 500 17 0

Laboratory study No Health Consumer Health and Safety Individuals or Households 200 67 0

In-store study invitation No Health Consumer Health and Safety Individuals or Households 300 25 0

In-store study No Health Consumer Health and Safety Individuals or Households 60 45 0

2014-01-30-05:00

0915-0034 201207-0915-004 0915
             
        "Health Education Assistance Loan (HEAL) Program: Forms"
             
          
        
The HEAL forms are required for lenders to make application to the HEAL insurance program, to report accurately and timely on loan actions, including transfer of loans to a secondary agent, and to establish the repayment status of borrowers. These reports assist DHHS in diligent administration of the HEAL program which protects the Government's financial interest. 2015-09-30-04:00 Active Jodi Duckhorn 301 443-1984 No No No 151 23 0

Health Education Assistance Loan (HEAL) Program: Forms No Health Health Care Services
2 HRSA 508 Yes Yes Fillable Fileable Form and instruction HRSA-508 BorDefer.docx 1 HRSA 504 Yes No Fillable Printable Form and instruction HRSA-504.doc
Private Sector 151 23 0

2012-09-18-04:00

0915-0036 201108-0915-002 0915
             
        "Health Education Assistance Loan (HEAL) Program:  Lender's Application for Insurance Claim Form and Request for Collection Assistance Form"
             
          
        
The HEAL Lender's Application for Insurance Claim and the Request for Collection Assistance forms are used in the administration of the Health Education Assistant Loan (HEAL) program. The HEAL program provided federally insured loans to students in certain health professions discliplines, and these forms are used in the administration of the HEAL program. The Lender's Application for Insurance Claim is used by the lending institution to request payment of a claim by the Federal Government. The Request for Collection Assistance form is used by the lender to request pre-claim assistance from the Department of Health and Human Services. 2014-10-31-04:00 Active Carla Haddad Carla.Haddad@hrsa.hhs.gov 301 443-0165 No No No 6149 1165 2594

Health Education Assistance Loan (HEAL) Program: Lender's Application for Insurance Claim Form and Request for Collection Assistance Form No Health Health Care Services
1 513 Form Yes Yes Fillable Fileable Form HRSA-513 Form.doc
Private Sector 5785 983 46

HEAL Lender's Application for Insurance Claim No Health Health Care Services
2 Form 510 Yes No Fillable Fileable Form LENDER 510 FORM.docx Yes No Printable Only Instruction LENDERS APPLICATION FOR INSURANCE FORM.docx
Private Sector 364 182 2548

2011-10-31-04:00

0915-0043 201212-0915-003 0915
             
        "Health Education Assistance Loan (HEAL)"
             
          
        
This is a request for extension of clearance to collect data on HEAL loans such as the cost of the loans(s) and to determine which lenders may have excessive delinquencies/defaulted loans. 2016-02-29-05:00 Active Jodi Duckhorn 301 443-1984 No No No 410 220 0

HRSA 512- Holder's/Call Report No Health Health Care Services
1 512 Yes No Fillable Printable Form and instruction HRSA-512.docm
Private Sector 60 45 0

Repayment Schedule HRSA-502 1,2 No Health Health Care Services
2 502-2 Yes No Fillable Printable Form and instruction HRSA-502-2.docm 1 502-1 Yes No Fillable Printable Form and instruction HRSA-502-1.docm
Private Sector 350 175 0

2013-02-07-05:00

0915-0044 201204-0915-002 0915
             
        "Health Professions Student Loan and Nursing Student Loan Programs - Forms"
             
          
        
Under the HPSL Programs, the Department provides funds to schools for long-term, low interest loans to students attending schools of medicine, osteopathic medicine, dentistry, veterinary medicine, optometry, podiatric medicine, and pharmacy. Under the NSL Programs, the Department provides funds to schools of nursing for long-term, low interest loans to students in programs leading to a diploma in nursing, an associate degree, a baccalaureate degree, or a graduate degree in nursing. 2015-07-31-04:00 Active Jodi Duckhorn 301 443-1984 No No No 4068 11733 0

Health Professions Student Loan and Nursing Student Loan Programs - Forms No Health Health Care Services
Yes Yes Printable Only Instruction AOR Guidance 2012 - Revised April 20 - DSLS.docx 3 AOR - HRSA 501 - NON-PCL Yes Yes Fillable Fileable Form NON-PCL AOR - REVISED April 20 2012 - DSLS.docx 2 AOR - HRSA 501 - PCL Yes Yes Fillable Fileable Form PCL AOR April 20 2012 - DSLS.docx 1 Deferment HRSA 519 Yes Yes Fillable Fileable Form Revised Deferment Form sent to OMB -- grantee comments included.docx
Private Sector 4068 11733 0

2012-07-16-04:00

0915-0047 201112-0915-004 0915
             
        "Health Professions Student Loan (HPSL) Program and Nursing Student Loan (NSL) Program:  Administrative Requirements (Regs. & Policy)"
             
          
        
This activity is necessary to document that schools are properly administering the HPSL and NSL programs in accordance with statutory and regulatory requirements. The record keeping and reporting requirements are used to determine that schools are exercising sound billing and collection procedures to ensure that Federal monies are available to recycle the future HPSL and NSL awards. 2015-03-31-04:00 Active Carla Haddad Carla.Haddad@hrsa.hhs.gov 301 443-0165 No No No 134313 49487 0

Health Professions Student Loan (HPSL) Program and Nursing Student Loan (NSL) Program: Administrative Requirements (Regs. & Policy) No Health Health Care Services Private Sector 134313 49487 0

2012-03-23-04:00

0915-0061 201304-0915-001 0915
             
        "BHPr Performance Report for Grants and Cooperative Agreements"
             
          
        
The BHPr Performance Report for Grants and Cooperative Agreements (formerly known as the Uniform Progress Report (UPR) for HRSA Continuation Training Grants) is an annual progress report required from each health professions and nursing education grantees who has an approved, funded project with a project period of more than one year. The report is required to determine the extent to which objectives of the project have been met so that a decision regarding continuation funding can be made. 2016-05-31-04:00 Active Jodi Duckhorn 301 443-1984 No Yes No 3526 7737 0

BHPr Performance Report No Health Health Care Services
1 PRGCA Manual Yes Yes Fillable Fileable Form and instruction PRGCA_Manual Final 06082012.pdf
Private Sector 0 0 0

BHPr Program Applications No Health Health Care Services
2 BHPr Program Applications Yes Yes Fillable Fileable Form and instruction BHPr grant appl forms_SS.docx
Private Sector 0 0 0

BHPr Performance Measures Forms No Health Health Care Services
1 BHPr Performance Measures Forms Yes Yes Fillable Fileable Form and instruction Forms.pdf 2 BHPr Progress Report Yes Yes Fillable Fileable Form and instruction BHPr Progress Report.docx
Private Sector 3526 7737 0

2013-05-22-04:00

0915-0077 201206-0915-005 0915
             
        "Uncompensated Services Assurance Report"
             
          
        
Under the Hill-Burton Act, the government provides grants and loans for construction or renovation of health care facilities under the condition that facilitates provide services to persons unable to pay. Facilitates are required to provide assurances that the required level of uncompensated care is being provided, and that certain notification and record keeping procedures are being followed. 2015-08-31-04:00 Active Carla Haddad Carla.Haddad@hrsa.hhs.gov 301 443-0165 No No No 6441 10786 0

Uncompensated Services Assurance Report No Health Health Care Services
710 Uncompensated Services Assurance Report ftp://ftp.hrsa.gov/hillburton/servassure.pdf Yes Yes Fillable Fileable Form and instruction HRSAForm710.pdf
Private Sector 6441 10786 0

2012-08-31-04:00

0915-0108 201305-0915-002 0915
             
        "Health Education Assistance Loan (HEAL) Program Regs."
             
          
        
The Health Education Assistance Loan (HEAL) Program regulatory requirements for reporting, recordkeeping, and notification are approved under OMB No.0915-0108. The HEAL program provided federally insured loans to students in schools for certain health professions. These reporting, notification, and recordkeeping requirements insure that the lenders, holders, and schools participating in the HEAL program follow sound management procedures in the administration of Federally-insured student loans. The basic purpose of the program was to assure the availablity of funds for loans to eligible students who needed to borrow money to pay for their educational costs. 2016-06-30-04:00 Active Jodi Duckhorn 301 443-1984 No No No 158564 29029 0

Health Education Assistance Loan (HEAL) Program Recordkeeping Requirements No Health Health Care Services Private Sector 39000 9100 0

Health Education Assistance Loan (HEAL) Program Reporting Regulations No Health Health Care Services Private Sector 60 12 0

Health Education Assistance Loan (HEAL) Program Notification Requirements No Health Health Care Services Private Sector 119504 19917 0

2013-06-04-04:00

0915-0126 201304-0915-002 0915
             
        "National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners:  Regulations and Forms"
             
          
        
The National Practitioner Data Bank (NPDB) is required to receive and release under 45 CFR Part 60 certain adverse data regarding physicians, dentists, and other licensed health care practitioners. Data collected on adverse actions and information relating to the professional competence and condcut of physicians and other health care practitioners will be shared with hospitals, licensing boards, professional societies, and selected health providers. These data will be used to maintain and improve health care and will be obtained from insurers, licensure boards, hospitals, and other providers. 2016-05-31-04:00 Active Jodi Duckhorn 301 443-1984 No Yes No 1696115 265978 0

National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Pract No Health Health Care Services
0915-0126 NPDB Forms NPDB Forms Yes Yes Fillable Fileable Form 0915-0126_NPDB Forms_2010.pdf NPDB Identity Proofing Forms NPDB Identity Proofing Forms Yes Yes Fillable Fileable Form and instruction NPDB-HIPDB E-Authentication and Identity Proofing Forms.doc
Private Sector 0 0 0

Section 1921 forms No Health Public Health Monitoring
1 60.9: Licensure Actions Yes Yes Fillable Fileable Signable Form and instruction State Licensure Initial - Individual Subject.pdf 2 60.10: Adverse Actions - Private Accreditation Yes Yes Fillable Fileable Signable Form and instruction Accreditation Initial - Organization Subject.pdf 3 60.10: Adverse Actions - Peer Review Organizations Yes Yes Fillable Fileable Signable Form and instruction Peer Review Organization Initial - Individual Subject.pdf
Private Sector 0 0 0

Correction, Revision to Action, Correction of Revision to Action, Void, Action on Appeal No Health Immunization Management
1 Correction, Revision to Action, Correction of Revision to Action, Void, Action on Appeal Yes Yes Fillable Fileable Form and instruction 1.Correction,RevisiontoAction,Void,NoticeofAppeal.pdf
State, Local, and Tribal Governments 38785 9696 0

Medical Malpractice Payment No Health Immunization Management
2 Medical Malpractice Payment Yes Yes Fillable Fileable Form and instruction 2.Medical Malpractice Payment.pdf
State, Local, and Tribal Governments 14193 10645 0

State Licensure No Health Immunization Management
3 State Licensure Yes Yes Fillable Fileable Form and instruction 3.State Licensure.pdf
State, Local, and Tribal Governments 28700 21525 0

DEA/Federal Licensure No Health Immunization Management
4 DEA/Federal Licensure Yes Yes Fillable Fileable Form and instruction 4.DEA_Federal Licensure.pdf
Federal Government 499 374 0

Peer Review Organization No Health Immunization Management
5 Peer Review Organization Yes Yes Fillable Fileable Form and instruction 5.Peer Review Organization.pdf
Private Sector 10 8 0

Accreditation No Health Immunization Management
6 Accreditation Yes Yes Fillable Fileable Form and instruction 6.Accreditation.pdf
Private Sector 10 8 0

Title IV Clinical Privileges Actions No Health Immunization Management
7 Title IV Clinical Privileges Actions Yes Yes Fillable Fileable Form and instruction 7.Title IV Clinical Privileges Actions.pdf
State, Local, and Tribal Governments 962 722 0

Professional Society No Health Immunization Management
8 Professional Society Yes Yes Fillable Fileable Form and instruction 8.Professional Society.pdf
Private Sector 71 53 0

Criminal Conviction (Guilty Plea or Trial) No Health Immunization Management
9 Criminal Conviction (Guilty Plea or Trial) Yes Yes Fillable Fileable Form and instruction 9.Criminal Conviction (Guilty Plea or Trial).pdf
State, Local, and Tribal Governments 1023 767 0

Deferred Conviction or Pre-Trial Diversion No Health Immunization Management
10 Deferred Conviction or Pre-Trial Diversion Yes Yes Fillable Fileable Form and instruction 10.Deferred Conviction or Pre-Trial Diversion.pdf
State, Local, and Tribal Governments 126 95 0

Nolo Contendere (no contest) plea No Health Immunization Management
11 Nolo Contendere (no contest) plea Yes Yes Fillable Fileable Form and instruction 11.Nolo Contendere (No Contest Plea).pdf
State, Local, and Tribal Governments 63 47 0

Injunction No Health Immunization Management
12 Injunction Yes Yes Fillable Fileable Form and instruction 12.Injunction.pdf
State, Local, and Tribal Governments 10 8 0

Civil Judgment No Health Immunization Management
13 Civil Judgement Yes Yes Fillable Fileable Form and instruction 13.Civil Judgment.pdf
State, Local, and Tribal Governments 10 8 0

Exclusion/Debarment No Health Immunization Management
14 Exclusion/Debarment Yes Yes Fillable Fileable Form and instruction 14.Exclusion_Debarment.pdf
State, Local, and Tribal Governments 2402 1802 0

Government Administrative No Health Immunization Management
15 Government Administrative Yes Yes Fillable Fileable Form and instruction 15.Government Administrative.pdf
State, Local, and Tribal Governments 2682 2012 0

Health Plan Action No Health Immunization Management
16 Health Plan Action Yes Yes Fillable Fileable Form and instruction 16.Health Plan Actions.pdf
State, Local, and Tribal Governments 561 421 0

One Time Query for an Individual No Health Immunization Management
17 One Time Query for an Individual Yes Yes Fillable Fileable Form and instruction 17.One Time Query for an Individual.pdf
State, Local, and Tribal Governments 986552 78924 0

One Time Query for an Organization No Health Immunization Management
18 One Time Query for an Organization Yes Yes Fillable Fileable Form and instruction 18.One Time Query for an Organization.pdf
State, Local, and Tribal Governments 18892 1511 0

Self-Query on an Individual No Health Immunization Management
19 Self-Query on an Individual Yes Yes Fillable Fileable Form and instruction 19.Self-Query on an Individual.pdf
Individuals or Households 154824 65026 0

Self-Query on an Organization No Health Immunization Management
20 Self-Query on an Organization Yes Yes Fillable Fileable Form and instruction 20.Self-Query on an Organization.pdf
State, Local, and Tribal Governments 1095 460 0

Continuous Query No Health Immunization Management
21 Continuous Query Yes Yes Fillable Fileable Form and instruction 21.Continuous Query.pdf
State, Local, and Tribal Governments 387767 31021 0

Subject Statement and Dispute No Health Immunization Management
22 Subject Statement and Dispute Yes Yes Fillable Fileable Form and instruction 22.Subject Statement and Dispute.pdf
Individuals or Households 3347 2510 0

Request for Secretarial Review No Health Immunization Management
23 Request for Secretarial Review Yes Yes Fillable Fileable Form and instruction 23.Request for Secretarial Review.pdf
Individuals or Households 83 664 0

Entity Registration (Initial) No Health Immunization Management
24 Entity Registration (Initial) Yes Yes Fillable Fileable Form and instruction 24.Entity Registration (Initial).pdf
State, Local, and Tribal Governments 35915 35915 0

Entity Registration (Renewal & Update) No Health Immunization Management
25 Entity Registration (Renewal & Update) Yes Yes Fillable Fileable Form and instruction 25.Entity Registration (Renewal and Update).pdf
State, Local, and Tribal Governments 15461 1237 0

Agent Registration (Initial) No Health Immunization Management
26 Agent Registration (Initial) Yes Yes Fillable Fileable Form and instruction 26.Agent Registration (Initial).pdf
State, Local, and Tribal Governments 100 25 0

Agent Registration (Renewal & Update) No Health Immunization Management
27 Agent Registration (Renewal & Update) Yes Yes Fillable Fileable Form and instruction 27.Agent Registration (Renewal and Update).pdf
State, Local, and Tribal Governments 100 25 0

Electronic Transfer of Funds (ETF) Authorization No Health Immunization Management
28 Electronic Transfer of Funds (ETF) Authorization Yes Yes Fillable Fileable Form and instruction 28.Electronic Transfer of Funds Authorization.pdf
State, Local, and Tribal Governments 562 141 0

Authorized Agent Designation No Health Immunization Management
29 Authorized Agent Designation Yes Yes Fillable Fileable Form and instruction 29.Authorized Agent Designation.pdf
State, Local, and Tribal Governments 1290 323 0

Account Discrepancy No Health Immunization Management
30 Account Discrepancy Yes No Fillable Fileable Form and instruction 30.Account Discrepancy Form.pdf
State, Local, and Tribal Governments 20 5 0

2013-05-28-04:00

0915-0127 201311-0915-003 0915
             
        "The National Health Service Corps (NHSC) Loan Repayment Program"
             
          
        
The National Health Service Corps (NHSC) Loan Repayment Program (LRP) was established to assure an adequate supply of trained primary care health professionals to provide services in the neediest Health Professional Shortage Areas. Under this program, HHS agrees to repay the educational loans of the primary health care professionals. In return, the health professionals agree to service for a specified period of time in a federally designated HPSA approved by the Secretary for LRP participants. 2017-01-31-05:00 Active Jodi Duckhorn 301 443-1984 No Yes Yes 9350 8555 0

The National Health Service Corps (NHSC) Loan Repayment Program Application No Health Illness Prevention
1 NHSC LRP Application Yes Yes Fillable Fileable Form and instruction NHSC LRP Online Application User Guide Dec 2012.doc
Individuals or Households 8200 8200 0

0127 NHSC Community Site Information Form No Health Health Care Services
0127-2 Employment Verification and Community Site Info For Yes Yes Fillable Fileable Form Employment Verification and Community Site Info Form.pdf
Individuals or Households 0 0 0

0127 NHSC Loan Information and Verification Form No Health Health Care Services
0127-3 Loan Information and Verification Form Yes Yes Fillable Fileable Form Loan Info and Verification Form.pdf
Individuals or Households 0 0 0

Privacy Act Release Authorization Form No Health Illness Prevention
2 Privacy Act Release Authorization Form Yes Yes Fillable Fileable Form and instruction FY13 NHSC LRP Privacy Act Release Authorization Form.pdf
Individuals or Households 100 10 0

NHSC Alumni Database No Health Health Care Services
0127-5 Alumni contact info Yes Yes Fillable Fileable Form NHSC Alumni Database Screenshot_8 24 10.doc
Individuals or Households 0 0 0

NHSC Self-Certification Form No Health Health Care Services
0127-6 NHSC Self-Certification Yes Yes Fillable Fileable Form Self-Certification Form.pdf
Individuals or Households 0 0 0

Authorization for Disclosure of Loan Information Form No Health Illness Prevention
3 Authorization for Disclosure of Loan Information Form Yes Yes Fillable Fileable Form and instruction FY13 NHSC Authorization for Disclosure of Loan Information Form.pdf
Individuals or Households 150 15 0

Private Practice Option Form No Health Illness Prevention
4 Private Practice Option Form Yes Yes Fillable Fileable Form and instruction PRIVATE PRACTICE OPTION Forms_revised_071613.docx
Individuals or Households 300 30 0

Verification of Disadvantaged Background Form No Health Illness Prevention
5 Verification of Disadvantaged Background Form Yes Yes Fillable Fileable Form and instruction NHSC LRP Verification of Disadvantaged Background Form Final.pdf
Individuals or Households 600 300 0

2014-01-27-05:00

0915-0140 201101-0915-001 0915
             
        "The Nursing Education Loan Repayment Program"
             
          
        
Approval is requested for the application and monitoring forms for the Nursing Education Loan Repayment Program (NELRP). Under the NELRP, registered nurses are offered the opportunity to enter into a contractual agreement to receive loan repayment for some of their qualifying education loan balances. This repayment is in exchange for agreeing to servie full-time as a registered nurse for 2-3 years at a health care facilitiy with a critical shortage of nurses. 2014-04-30-04:00 Active Amanda Cash amanda.cash@hrsa.hhs.gov 301 443-0208 No No No 78300 48925 0

The Nursing Education Loan Repayment Program Application No Health Health Care Services
Yes Yes Fillable Fileable Instruction 11 1 10 NELRP FY11 APG.docx NELRP_001 Application Guidance and Forms Yes Yes Fillable Fileable Form and instruction NELRP_application_screenshots.doc
Individuals or Households 8000 12000 0

Loan Information and Verification Form No Health Health Care Services
NELRP_2 Loan Information and Verification Form Yes Yes Fillable Fileable Form FY 11 Forms Package.docx
Individuals or Households 24000 24000 0

Employment Verification and Critical Shortage Facility Form No Health Health Care Services
NELRP_003 Employment Verification and Critical Shortage Facility Form Yes Yes Fillable Fileable Form FY 11 Forms Package.docx
Individuals or Households 7500 3750 0

Authorization for Release of Employment Information Form No Health Health Care Services
NELRP_006 Authorization for Release of Employment Information Form Yes Yes Fillable Fileable Form FY 11 Forms Package.docx
Individuals or Households 8000 800 0

Application Checklist and Self-Certification Form No Health Health Care Services
NELRP_006 Application Checklist and Self-Verification Form Yes Yes Fillable Fileable Form FY 11 Forms Package.docx
Individuals or Households 8000 4000 0

Pre-Award Script No Health Health Care Services
6 Pre-Award Script Yes Yes Fillable Fileable Form Phone Script for Applicant Award Verification - 2007.doc
Individuals or Households 0 0 0

Participant Semi-Annual Employment Verification Form No Health Health Care Services
7 Emp Verification Form Yes Yes Fillable Fileable Form 6-Month EVF.doc
Individuals or Households 4600 2300 0

Employment Verification for Nurse Faculty Appointment Form No Health Health Care Services
NELRP_004 Employment Verification for Nurse Faculty Appointment Form Yes Yes Fillable Fileable Form FY 11 Forms Package.docx
Individuals or Households 500 125 0

Authorization to Release Information Form No Health Health Care Services
NELRP_008 Authorization to Release Information Form Yes Yes Fillable Fileable Form FY 11 Forms Package.docx
Individuals or Households 8000 800 0

Certification Regarding Debarment, Suspension, Disqualification and Related Matters Form No Health Health Care Services
NELRP_009 Certification Regarding Debarment, Suspension, Disqualification and Related Matters Form Yes Yes Fillable Fileable Form FY 11 Forms Package.docx
Individuals or Households 8000 800 0

Certification Of Accreditation Status for School of Nursing Education Programs Form No Health Health Care Services
NELRP_010 Certification Of Accreditation Status for School of Nursing Education Programs Form Yes Yes Fillable Fileable Form FY 11 Forms Package.docx
Individuals or Households 500 50 0

The Verification of Acceptance or Decline of Award form No Health Health Care Services
NELRP_11 The Verification of Acceptance or Decline of Award form Yes Yes Fillable Fileable Form FY 11 Forms Package.docx
Individuals or Households 1200 300 0

2011-04-25-04:00

0915-0146 201101-0915-003 0915
             
        "Application for Participation in the National Health Service Corps Scholarship Program"
             
          
        
The National Health Service Corps (NHSC) Scholarship Program offers scholarship awards to health professions students in return for the provision of full-time clinical services in a federally designated Health Professional Shortage Area. The NHSC Scholarship application collects information to select applicants for scholarship awards. The application information is necessary in order to determine those applicants that meet award criteria specified by Federal statute and regulation. 2014-04-30-04:00 Active Amanda Cash amanda.cash@hrsa.hhs.gov 301 443-0208 No No No 3660 7270 0

Application for Participation in the National Health Service Corps Scholarship Program No Health Health Care Services
NHSC_SP_001 NHSC_SP_001 Yes Yes Fillable Fileable Form Instructions and Forms 2011.docx NHSC_SP_002 Acceptance & Declination Form Yes Yes Fillable Fileable Form NHSC Applicant acceptance or denial letter-revised.doc Yes Yes Fillable Fileable Instruction FY2011 NHSC SP Guidance 10.25.10.docx
Individuals or Households 1800 6155 0

Data Collection Worksheet - School/Site Form No Health Health Care Services
NHSC_SP_003 Data Collection Worksheet Yes Yes Fillable Fileable Form NHSC DCW.xls
Private Sector 400 400 0

Six-Month Service Obligation Verification Form - School/Sites Forms No Health Health Care Services
NHSC_SP_004 Six-Month Service Obligation Verification Form Yes Yes Fillable Fileable Form 6-Month Verification Form_revised_12012010.docx
Individuals or Households 1400 700 0

Deferment Request Form - Participant Form No Health Health Care Services
NHSC_SP_005 Deferment Request Form Yes Yes Fillable Fileable Form Deferment Request Form.docx
Individuals or Households 60 15 0

2011-04-25-04:00

0915-0149 201311-0915-004 0915
             
        "Scholarships for Disadvantaged Students Application Program Specific Form"
             
          
        
The Scholarships for Disadvantaged Students (SDS) Program provides scholarship funds to schools for distribution to undergraduate and graduate students from disadvantage backgrounds who are preparing for the health professions. 2017-01-31-05:00 Active Jodi Duckhorn 301 443-1984 No Yes No 598 9952 0

Scholarships for Disadvantaged Students (SDS) Program Application Form No Health Health Care Services
1a SDS App Instructions Yes Yes Fillable Fileable Form and instruction OPC Program Specific form instructions AY 2012 final OMBrevised 11-1-2013.docx 1 SDS App Yes Yes Fillable Fileable Form and instruction OPCCopy of SDS specific form 2012 - revised.xlsx
Private Sector 400 5200 0

Scholarships for Disadvantaged Students Performance Report Form No Health Illness Prevention
2 SDSPR Yes Yes Fillable Fileable Form and instruction OPCCopy of SDS PR FY12 data template part 2 w-o codes.xlsx 2b SDSPR guidance Yes Yes Fillable Fileable Form and instruction OPCSDSPR Guidance FY 2012-13 11-1-2013.doc
Private Sector 198 4752 0

2014-01-27-05:00

0915-0150 201208-0915-002 0915
             
        "Faculty Loan Repayment Program Application"
             
          
        
The purpose of the Faculty Loan Repayment Program is to attract disadvantaged health professionals into faculty positions in accredited health professions schools by offering to make partial payments on education loans. In exchange, the graduate health professional agrees to have a contract with an accredited health professions school to serve as a faculty member for a minimum of two years. 2015-10-31-04:00 Active Jodi Duckhorn 301 443-1984 No No No 912 684 0

Faculty Loan Repayment Program Application No Health Health Care Services
2 FLRP Forms Yes Yes Printable Only Form and instruction FLRP Forms Package 2012_Final_04032012.doc 1 Online Application Yes Yes Fillable Fileable Form and instruction FLRP Online Application User Guide.pdf
Individuals or Households 912 684 0

FLRP Checklist No Health Health Care Services
002-FLRP 002-FLRP Yes Yes Fillable Fileable Form FLRP_checklist.pdf
Individuals or Households 0 0 0

FLRP Institution Employment-Loan Repayment Form No Health Health Care Services
003_FLRP FLRP_Inst Empl Repayment Form Yes Yes Fillable Fileable Form FLRP_Institution Employment-Loan Repayment Form.pdf
Individuals or Households 0 0 0

Loan Information and Verification Form No Health Health Care Services
004_FLRP Loan Information and Verification Form Yes Yes Fillable Fileable Form FLRP_Loan Information and Verification Form.pdf
Individuals or Households 0 0 0

FLRP Online Banking Form No Health Health Care Services
004_FLRP Online Banking Form Yes Yes Fillable Fileable Form FLRP_Online Banking Form.pdf
Individuals or Households 0 0 0

2012-10-12-04:00

0915-0151 201104-0915-002 0915
             
        "Ryan White CARE Act Dental Reimbursement Program"
             
          
        
Under the Ryan/White HIV/AIDS Treatment Modernization Act, accredited schools of dentistry, pre- and post-doctoral dental training programs, and dental hygiene education programs may apply for reimbursement of uncompensated costs for providing oral health care to HIV infected individuals. The Dental Services Form provides information on unreimbursed expenses and descriptions of selected program components in order to determine the reimbursement award amount and to report on provided services under the Act. 2014-06-30-04:00 Active Carla Haddad Carla.Haddad@hrsa.hhs.gov 301 443-0165 No No No 70 1400 0

Ryan White CARE Act Dental Reimbursement Program No Health Health Care Services
Yes No Fillable Printable Instruction 2011DSRInstructions032210.pdf 1 dental services form Yes Yes Fillable Fileable Form 2011DSRForm032210.pdf
Private Sector 70 1400 0

2011-06-29-04:00

0915-0157 201202-0915-001 0915
             
        "Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients Data System"
             
          
        
The Organ Procurement and Transplantation Network (OPTN) and the Scientific Registry for Transplant Recipients (SRTR) collect information on transplant recipients and transplant procedures in accordance with Section 372 of the Public Health Service Act. This information is required for to monitor and evaluate the scientific and clinical status of organ transplantation, and to ensure the distribution of organs equitably among transplant patients nationwide and adopt and use standards of quality for the acquisition and transportation of donated organs. The OPTN must maintain a national waiting list of individuals requiring organ transplants and maintain a computerized system for matching donor organs its transplant candidates list. 2015-03-31-04:00 Active Gerta Bardhoshi GBardhoshi@hrsa.gov 301 443-1129 No No No 477327 258318 0

OPTN- Deceased Donor Registration Worksheet No Health Health Care Services
Yes No Printable Only Instruction Deceased Donor Registration Instructions.pdf 1 Deceased Donor Registration Yes Yes Fillable Fileable Form Deceased Donor Registration Worksheet.pdf
Private Sector 13224 9918 0

OPTN- Living Donor Registration No Health Health Care Services
Yes No Printable Only Instruction Living Donor Registration Instructions.pdf 1 Living Donor Registration Yes Yes Fillable Fileable Form Living Donor Registration Worksheet.pdf
Private Sector 7153 4649 0

OPTN- Living Donor Follow-up No Health Health Care Services
1 Living Donor Follow-up No No Fillable Fileable Form Living Donor Follow Up Worksheet.pdf Yes No Printable Only Instruction Living Donor Follow Up Instructions.pdf
Private Sector 24258 12129 0

OPTN- Donor Histocompatibility No Health Health Care Services
Yes No Printable Only Instruction Donor Histocompatibility Instructions.pdf 1 Donor Histocompatibility Yes Yes Fillable Fileable Form Donor Histocompatibility Worksheet.pdf
Private Sector 14852 1485 0

OPTN- Recipient Histocompatibility No Health Health Care Services
1 Recipient Histocompatibility Yes Yes Fillable Fileable Form Recipient Histocompatibility Worksheet.pdf Yes No Printable Only Instruction Recipient Histocompatibility Instructions.pdf
Private Sector 27018 5404 0

OPTN- Heart Candidate Registration No Health Health Care Services
7 Heart Adult Candidate Transplant Registration Yes Yes Fillable Fileable Form Heart Adult Transplant Candidate Registration Worksheet.pdf 7b Heart Pediatric Transplant Candidate Registration Yes Yes Fillable Fileable Form Heart Pediatric Transplant Candidate Registration Worksheet.pdf Yes No Printable Only Instruction Heart Transplant Candidate Registration Instructions.pdf
Private Sector 3537 1769 0

OPTN- Lung Candidate Registration No Health Health Care Services
Yes No Printable Only Instruction Lung Transplant Candidate Registration Instructions.pdf 8b Lung Pediatric Transplant candidate Registration Worksheet Yes Yes Fillable Fileable Form Lung Pediatric Transplant Candidate Registration Worksheet.pdf 8 Lung Adult Transplant candidate Registration Worksheet Yes Yes Fillable Fileable Form Lung Adult Transplant Candidate Registration Worksheet.pdf
Private Sector 2706 1353 0

OPTN- Heart/Lung Candidate Registration No Health Health Care Services
9 Heart-Lung Adult Transplant Candidate Registration Worksheet Yes Yes Fillable Fileable Form Heart-Lung Adult Transplant Candidate Registration Worksheet.pdf 9b Heart-Lung Pediatric Transplant Candidate Registration Worksheet Yes Yes Fillable Fileable Form Heart-Lung Pediatric Transplant Candidate Regisrtation Worksheet.pdf Yes No Printable Only Instruction Heart-Lung Transplant Candidate Registration Instructions.pdf
Private Sector 50 25 0

OPTN- Thoracic Registration No Health Health Care Services
10e Thoracic Lung Adult Transplant Recipient Registration Worksheet Yes Yes Fillable Fileable Form Thoracic Lung Adult Transplant Recipient Registration Worksheet.pdf 10d Thoracic Heart-Lung Pediatric Transplant Recipient Registration Worksheet Yes Yes Fillable Fileable Form Thoracic Heart-Lung Pediatric Transplant Recipient Registration Worksheet.pdf 10c Thoracic Heart-Lung Adult Transplant Recipient Regisration Worksheet Yes Yes Fillable Fileable Form Thoracic Heart-Lung Adult Transplant Recipient Registration Worksheet.pdf 10b Thoracic Heart Pediatric Transplant Recipient Registration Worksheet Yes Yes Fillable Fileable Form Thoracic Heart Pediatric Transplant Recipient Registration Worksheet.pdf 10 Thoracic Heart Adult Transplant Recipient Registration Worksheet Yes Yes Fillable Fileable Form Thoracic Heart Adult Transplant Recipient Registration Worksheet.pdf 10f Thoracic Lung Pediatric Transplant Recipient Registration Worksheet Yes Yes Fillable Fileable Form Thoracic Lung Pediatric Transplant Recipient Registration Worksheet.pdf Yes No Printable Only Instruction Thoracic Transplant Recipient Registration Instructions.pdf
Private Sector 4454 3341 0

OPTN- Thoracic Follow-up No Health Health Care Services
Yes No Printable Only Instruction Thoracic Transplant Recipient Follow Up Instructions.pdf Yes No Printable Only Instruction Thoracic Post 5 Year Transplant Recipient Follow Up Instructions.pdf 9 Thoracic Heart Lung Adult Transplant Recipient Follow Up Yes Yes Fillable Fileable Form Thoracic_Heart-Lung_Adult_Transplant_Recipient_Follow_Up_Worksheet[1].pdf 10 Thoracic Heart Lung Pediatric 6 Month Transplant Recipient Follow Up Yes Yes Fillable Fileable Form Thoracic_Heart-Lung_Pediatric_6_Month_Transplant_Recipient_Follow_Up_Worksheet[1].pdf 12 Thoracic Heart Lung Pediatric Transplant Recipient Follow Up Yes Yes Fillable Fileable Form Thoracic_Heart-Lung_Pediatric_Transplant_Recipient_Follow_Up_Worksheet[1].pdf 15 Thoracic Lung Adult Transplant Recipient Follow Up Yes Yes Fillable Fileable Form Thoracic_Lung_Adult_Transplant_Recipient_Follow_Up_Worksheet[1].pdf 16 Thoracic Lung Pediatric 6 Month Transplant Recipient Follow Up Yes Yes Fillable Fileable Form Thoracic_Lung_Pediatric_6_Month_Transplant_Recipient_Follow_Up_Worksheet.pdf Yes No Printable Only Instruction Thoracic 6 Month Transplant Recipient Follow Up Instructions.pdf 17 Thoracic Lung Pediatric Post 5 Yes Yes Fillable Fileable Form Thoracic Lung Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet.pdf 14 Thoracic Lung Adult Post 5 Follow Up Yes Yes Fillable Fileable Form Thoracic Lung Adult Post 5 Year Transplant Recipient Follow Up Worksheet.pdf 13 Thoracic Lung Adult 6 month Follow UP Yes Yes Fillable Fileable Form Thoracic Lung Adult 6 Month Transplant Recipient Follow Up Worksheet.pdf 11 Thoracic Heart Lung Pediatric Post 5 Yes Yes Fillable Fileable Form Thoracic Heart-Lung Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet.pdf 8 Thoracic Heart Lung Adult Post 5 Yes Yes Fillable Fileable Form Thoracic Heart-Lung Adult Post 5 Year Transplant Recipient Follow Up Worksheet.pdf 7 Thoracic Heart Lung Adult Six month Yes Yes Fillable Fileable Form Thoracic Heart-Lung Adult 6 Month Transplant Recipient Follow Up Worksheet.pdf 5 Thoracic Heart Pediatric Post 5 Follow Up Yes Yes Fillable Fileable Form Thoracic Heart Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet.pdf 2 Thoracic Heart Adult Post 5 year Yes Yes Fillable Fileable Form Thoracic Heart Adult Post 5 Year Transplant Recipient Follow Up Worksheet.pdf 1 Thoracic Heart Adult 6 month Follow-up Yes Yes Fillable Fileable Form Thoracic Heart Adult 6 Month Transplant Recipient Follow Up Worksheet.pdf 6 Thoracic Heart Pediatric Transplant Recipient Follow Up Yes No Fillable Fileable Form Thoracic_Heart_Pediatric_Transplant_Recipient_Follow_Up_Worksheet[1].pdf 4 Thoracic Heart Pediatric 6 Month Transplant Recipient Follow Up Yes Yes Fillable Fileable Form Thoracic_Heart_Pediatric_6_Month_Transplant_Recipient_Follow_Up_Worksheet[1].pdf 3 Thoracic Heart Adult Transplant Recipient Follow Up Yes Yes Fillable Fileable Form Thoracic_Heart_Adult_Transplant_Recipient_Follow_Up_Worksheet[1].pdf 18 Thoracic Lung Pediatric Transplant Recipient Follow Up Yes Yes Fillable Fileable Form Thoracic_Lung_Pediatric_Transplant_Recipient_Follow_Up_Worksheet[1].pdf
Private Sector 36287 23587 0

OPTN- Kidney Candidate Registration No Health Health Care Services
Yes No Printable Only Instruction Kidney Transplant Candidate Registration Instructions.pdf 1 Kidney Adult Candidate Registration Yes Yes Fillable Fileable Form Kidney Adult Transplant Candidate Registration Worksheet.pdf 2 Kidney Pediatric Transplant Yes Yes Fillable Fileable Form Kidney Pediatric Transplant Candidate Registration Worksheet.pdf
Private Sector 36806 18403 0

OPTN- Kidney Registration No Health Health Care Services
2 Kidney Pediatric Transplant Recipient Registration Yes Yes Fillable Fileable Form Kidney Pediatric Transplant Recipient Registration Worksheet.pdf Yes No Printable Only Instruction Kidney Transplant Recipient Registration Instructions.pdf 1 Kidney Adult Transplant Recipient Registration Yes Yes Fillable Fileable Form Kidney Adult Transplant Recipient Registration Worksheet.pdf
Private Sector 17208 12906 0

OPTN- Kidney Follow-up No Health Health Care Services
14d Kidney Pediatric Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Kidney_Pediatric_Transplant_Recipient_Follow_Up_Worksheet[1].pdf 14c Kidney Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Kidney_Pediatric_Post_5_Year_Transplant_Recipient_Follow_Up_Worksheet[1].pdf 14b Kidney Adult Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Kidney Adult Transplant Recipient Follow Up Worksheet.pdf 14 Kidney Adult Post 5 year Transplant Recipient Follow Up worksheet Yes Yes Fillable Fileable Form Kidney Adult Post 5 YearTransplant Recipient Follow Up Worksheet.pdf Yes No Printable Only Instruction Kidney Transplant Recipient Follow Up Instructions.pdf Yes No Printable Only Instruction Kidney Post 5 Year Transplant Recipient Follow Up Instructions.pdf
Private Sector 165627 91095 0

OPTN- Liver Candidate Registration No Health Health Care Services
15b Liver Pediatric Transplant candidate Registration Worksheet Yes Yes Fillable Fileable Form Liver Pediatric Transplant Candidate Registration Worksheet.pdf 15 Liver Adullt Transplant candidate Registration Worksheet Yes Yes Fillable Fileable Form Liver Adult Transplant Candidate Regisrtation Worksheet.pdf Yes No Printable Only Instruction Liver Transplant Candidate Registration Instructions.pdf
Private Sector 12936 6468 0

OPTN- Liver Registration No Health Health Care Services
16 Liver Adult Transplant Recipient Registration Worksheet Yes Yes Fillable Fileable Form Liver Adult Transplant Recipient Registration Worksheet.pdf Yes No Printable Only Instruction Liver Transplant Recipient Registration Instructions.pdf 16b Liver Pediatric Transplant Recipient Registration Worksheet Yes Yes Fillable Fileable Form Liver Pediatric Transplant Recipient Registration Worksheet.pdf
Private Sector 6336 4118 0

OPTN- Liver Follow-up No Health Health Care Services
17d Liver Pediatric Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Liver_Pediatric_Transplant_Recipient_Follow_Up_Worksheet[1].pdf 17 Liver Adult Post 5 year Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Liver Adult Post 5 Year Transplant Recipient Follow Up Worksheet.pdf 17b Liver Adult Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Liver_Adult_Transplant_Recipient_Follow_Up_Worksheet[1].pdf 17c Liver Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Liver Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet.pdf Yes No Printable Only Instruction Liver Transplant Recipient Follow Up Instructions.pdf Yes No Printable Only Instruction Liver Post 5 Year Transplant Recipient Follow Up Instructions.pdf
Private Sector 60588 30294 0

OPTN- Kidney/Pancreas Candidate Registration No Health Health Care Services
Yes No Printable Only Instruction Kidney-Pancreas Transplant Candidate Registration Instructions.pdf 18b Kidney-Pancreas Pediatric Transplant Candidate Registration Worksheet Yes Yes Fillable Fileable Form Kidney-Pancreas Pediatric Transplant Candidate Registration Worksheet.pdf 18 Kidney-Pancreas Adult Transplant Candidate Registration Worksheet Yes Yes Fillable Fileable Form Kidney-Pancreas Adult Transplant Candidate Registration Worksheet.pdf
Private Sector 1584 792 0

OPTN- Kidney/Pancreas Registration No Health Health Care Services
19 Kidney-Pancreas Adult Transplant Recipient Registration Yes Yes Fillable Fileable Form Kidney-Pancreas Adult Transplant Recipient Registration.pdf 19b Kidney-Pancreas Pediatric Tranplant Recipient Registration Worksheet Yes Yes Fillable Fileable Form Kidney-Pancreas Pediatric Transplant Recipient Registration Worksheet.pdf Yes No Printable Only Instruction Kidney-Pancreas Transplant Recipient Registration Instructions.pdf
Private Sector 864 778 0

OPTN- Kidney/Pancreas Follow-up No Health Health Care Services
Yes No Printable Only Instruction Kidney-Pancreas Transplant Recipient Follow Up Instructions.pdf 20 Kidney-Pancreas Adult Post 5 Year Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Kidney-Pancreas Adult Post 5 Year Transplant Recipient Follow Up Worksheet.pdf 20d Kidney-Pancreas Pediatric Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Kidney-Pancreas_Pediatric_Transplant_Recipient_Follow_Up_Worksheet[1].pdf Yes No Printable Only Instruction Kidney-Pancreas Post 5 Year Transplant Recipient Follow Up Instructions.pdf 20b Kidney-Pancreas Adult Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Kidney-Pancreas Adult Transplant Recipient Follow Up Worksheet.pdf 20c Kidney-Pancreas Pediatric Post 5 Year Transplant Recipient Follow Up Workshseet Yes Yes Fillable Fileable Form Kidney-Pancreas Pediatric Post 5 Year Transplant Recipient Follow Up Workshseet.pdf
Private Sector 10800 9180 0

OPTN- Pancreas Candidate Registration No Health Health Care Services
21b Pancreas and Pancreas Islets Pediatric Tranpslant Candidate Registration Worksheet Yes Yes Fillable Fileable Form Pancreas and Pancreas Islets Pediatric Tranpslant Candidate Registration Worksheet.pdf 21 Pancreas and Pancreas Islets Adult Transplant Candidate Registration Worksheet Yes Yes Fillable Fileable Form Pancreas and Pancreas Islets Adult Transplant Candidate Registration Worksheet.pdf Yes No Printable Only Instruction Pancreas and Pancreas Islets Transplant Candidate Registration Instructions.pdf
Private Sector 576 288 0

OPTN- Pancreas Registration No Health Health Care Services
22b Pancreas Pediatric Transplant Recipient Registration Worksheet Yes Yes Fillable Fileable Form Pancreas Pediatric Transplant Recipient Registration Worksheet.pdf 22 Pancreas Adult Transplant Recipient Registration Worksheet Yes Yes Fillable Fileable Form Pancreas Adult Transplant Recipient Registration Worksheet.pdf Yes No Printable Only Instruction Pancreas Transplant Recipient Registration Instructions.pdf
Private Sector 288 216 0

OPTN- Pancreas Follow-up No Health Health Care Services
23d Pancreas Pediatric Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Pancreas Pediatric Transplant Recipient Follow Up Worksheet.pdf 23c Pancreas Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Pancreas Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet.pdf Yes No Printable Only Instruction Pancreas Post 5 Year Transplant Recipient Follow Up Instructions.pdf Yes No Printable Only Instruction Pancreas Transplant Recipient Follow Up Instructions.pdf 23 Pancreas Adult Post 5 Year Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Pancreas Adult Post 5 Year Transplant Recipient Follow Up Worksheet.pdf 23b Pancreas Adult Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Pancreas Adult Transplant Recipient Follow Up Worksheet.pdf
Private Sector 3312 2153 0

OPTN- Intestine Candidate Registration No Health Health Care Services
24 Intestine Adult Transplant Candidate Registration Worksheet Yes Yes Fillable Fileable Form Intestine Adult Transplant Candidate Registration Worksheet.pdf 24b Intestine Pediatric Transplant Candidate Registration Worksheet Yes Yes Fillable Fileable Form Intestine Pediatric Transplant Candidate Registration Worksheet.pdf Yes No Printable Only Instruction Intestine Transplant Candidate Registration Instructions.pdf
Private Sector 215 108 0

OPTN- Intestine Registration No Health Health Care Services
Yes No Printable Only Instruction Intestine Transplant Recipient Registration Instructions.pdf 25b Intestine Pediatric Transplant Recipient Registration Worksheet Yes Yes Fillable Fileable Form Intestine Pediatric Transplant Recipient Registration Worksheet.pdf 25 Intestine Adult Transplant Recipient Registration Worksheet Yes Yes Fillable Fileable Form Intestine Adult Transplant Recipient Registration Worksheet.pdf
Private Sector 129 116 0

OPTN- Intestine Follow-up No Health Health Care Services
26d Intestine Pediatric Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Intestine Pediatric Transplant Recipient Follow Up Worksheet.pdf 26b Intestine Adult Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Intestine Adult Transplant Recipient Follow Up Worksheet.pdf 26 Intestine Adult Post 5 Year Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Intestine Adult Post 5 Year Transplant Recipient Follow Up Worksheet.pdf Yes No Printable Only Instruction Intestine Transplant Recipient Follow Up Instructions.pdf Yes No Printable Only Instruction Intestine Post 5 Year Transplant Recipient Follow Up Instructions.pdf 26c Intestine Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet Yes Yes Fillable Fileable Form Intestine Pediatric Post 5 Year Transplant Recipient Follow Up Worksheet.pdf
Private Sector 1075 914 0

OPTN- Post Transplant Malignancy No Health Health Care Services
27b Pediatric Post Transplant Malignancy Worksheet Yes Yes Fillable Fileable Form Pediatric Post Transplant Malignancy Worksheet.pdf 27 Adult Post Transplant Malignancy Worksheet Yes Yes Fillable Fileable Form Adult Post Transplant Malignancy Worksheet.pdf Yes No Printable Only Instruction Post Transplant Malignancy Instructions.pdf
Private Sector 7579 1516 0

Death Referral Data No Health Health Care Services
1 Death Referral Data Yes Yes Fillable Fileable Form Death Referral Data Worksheet.pdf Yes No Printable Only Instruction Death Referral Data Instructions.pdf
Private Sector 696 6960 0

Death Notification Referal - Eligible No Health Health Care Services
1 Death Notification Referral Eligible Yes Yes Fillable Fileable Form Death Notification Registration Worksheet.pdf Yes No Printable Only Instruction Death Notification Registration Instructions.pdf
Private Sector 8410 4205 0

Death Notification Referral-Imminent No Health Health Care Services
Yes No Printable Only Instruction Death Notification Registration Instructions.pdf 1 Death Notification Referral Imminent Yes Yes Fillable Fileable Form Death Notification Registration Worksheet.pdf
Private Sector 7192 3596 0

Liver Explant Pathology No Health Illness Prevention
Yes No Printable Only Instruction Liver Explant Pathology Reporting Form Instructions.pdf 1 Liver Recipient Explant Pathology Worksheet Yes Yes Fillable Fileable Form Liver Recipient Explant Pathology Worksheet.pdf
Private Sector 1452 494 0

Pancreas Islet Candidate Registration No Health Health Care Services
2 Pancreas Islets Pediatric Yes Yes Fillable Fileable Form Pancreas and Pancreas Islets Pediatric Tranpslant Candidate Registration Worksheet.pdf 1 Pancreas Islets Adult Yes Yes Fillable Fileable Form Pancreas and Pancreas Islets Adult Transplant Candidate Registration Worksheet.pdf Yes No Printable Only Instruction Pancreas and Pancreas Islets Transplant Candidate Registration Instructions.pdf
Private Sector 115 58 0

2012-03-23-04:00

0915-0172 201111-0915-003 0915
             
        "Maternal and Child Health Services Block Grant Report"
             
          
        
The MCH Block Grant is a formula grant under which funds are awarded to all 59 States and jurisdictions upon their submission of an acceptable plan to meet the health services needs of the target populations of mothers, infants, children, and children with special health care needs. The data collected from grantees are necessary to manage and monitor the use of grant funds. 2015-01-31-05:00 Active Afabwaje Jatau AJatau@hrsa.gov 301 443-1435 No No No 59 14514 0

Maternal and Child Health Services Block Grant Report No Health Health Care Services
1 MCHB Block Grant Guidance for Application/Annual Report Yes Yes Fillable Fileable Form and instruction FINAL Application_Report AttachCGuidance_10-31-11 (2).docx
State, Local, and Tribal Governments 59 14514 0

2012-01-20-05:00

0915-0176 201302-0915-001 0915
             
        "Drug Pricing Program Reporting Requirements"
             
          
        
HRSA's Office of Pharmacy Affairs has audit guidelines and a dispute resolution process for the Drug Pricing Program which necessitate certain reporting and record keeping requirements when there is reasonable cause to believe a violation of section 340B(a)(5)(A) or (B) has occurred. These requirements provide a formal dispute resolution process for audits and other disputes for covered entities and participating drug manufacturers. 2016-05-31-04:00 Active Jodi Duckhorn 301 443-1984 No No No 50 1188 0

Drug Pricing Program Reporting Requirements No Health Health Care Services Private Sector 50 1188 0

2013-05-13-04:00

0915-0184 201102-0915-005 0915
             
        "Organ Procurement and Transplantation Network"
             
          
        
The final rule of the Organ Procurement and Transplantation Network (OPTN) established the final policies governing the OPTN. This ICR contains application requirements outlined in the rule regarding application procedures and policies of the OPTN and membership, designation, and transplant program requirements. This submission contains burden associated with the final rule for application for membership in the OPTN and requirements for membership, including compliance with OPTN policies and bylaws. 2014-04-30-04:00 Active Gerta Bardhoshi GBardhoshi@hrsa.gov 301 443-1129 No No No 36868 23503 0

Organ Procurement and Transplantation Network Application No Health Public Health Monitoring
15 B2_NewLDL_only_Cover_instructions www.optn.org Yes No Printable Only Form D_LAB_inhouse_appl_cover_and_Instructions_2010_Nov.doc 14 E_Lab_Independent_app www.optn.org Yes No Printable Only Form E_Lab_Independent_Application_2010_Nov.doc www.optn.org Yes No Printable Only Instruction B1_Cover_Instuctions_Add on program_2010_Nov.doc 13 A12_Lab_section_part_6 www.optn.org Yes No Printable Only Form A_11_Hospital based Lab_Part 6 Appl_2010_Nov.doc 11 A10_OPO_Inhouse www.optn.org Yes No Printable Only Form A10_OPO_inhouse_2010_Nov_Part 5.doc 10 A9_PI_App www.optn.org Yes No Printable Only Form A9_PI_appl_2010_Nov.doc 9 A8_HL_App www.optn.org Yes No Printable Only Form A8_HL_appl_2010_Nov.doc 8 C_OPO_App www.optn.og Yes No Printable Only Form C_OPO_application_independent_2010_Nov.doc 7 A7_LU_App www.optn.org Yes No Printable Only Form A7_LU_appl_2010_Nov 18.doc 6 A6_HR_App www.optn.org Yes No Printable Only Form A6_HR_appl_2010_Nov 22.doc 5 A5_PA_app Yes No Printable Only Form A5_PA_appl_2010_Nov.doc 3 A3_KI_LDK_Combined_app www.optn.org Yes No Printable Only Form A3_KI_LDK_combined appl_2010_Nov.doc 2 A2_part_1_2_General_facility www.optn.org Yes No Printable Only Form A2_Part 1_2_General_Facility.doc 4 A4_LI_LDL_combined_app Yes No Printable Only Form A4_LI_LDL_combined_appl_2010_Nov.doc 1 A1_Full_App_Cover_Instructions www.optn.org Yes No Printable Only Form and instruction A1_Full Appl_Cover_instructions_2010_Nov.doc 0 0 www.optn.org Yes No Printable Only Form B2_New_LDL_only_Cover_Instructions_Add on program.pdf 0 0 www.optn.org Yes No Printable Only Form A10_LDK_TX_program_appl_initial only.pdf
Private Sector 120 1800 0

OPTN Personnel Change Application No Health Public Health Monitoring
1 F_Cover_Instructions_Personnel www.optn.org Yes No Printable Only Form and instruction F_Cover_and_Instructions_Personnel Change Appl_2010_Nov.doc
Private Sector 324 3240 0

OPTN Non-Institutional Application No Health Public Health Monitoring
2 G_medical_scientific_app www.optn.org Yes No Printable Only Form and instruction G_Medical_Scientific_Org_appl_2010_Nov.doc 4 Individual_member_app www.optn.org Yes No Printable Only Form and instruction J_Individual_member_appl_2010_Nov.doc 3 Public_organ_app Yes No Printable Only Form and instruction H_Public_Org_appl_2010_Nov.doc 1 Business_Member_app www.optn.org Yes No Printable Only Form and instruction I_Business_member_appl_2010_Nov.doc
Private Sector 20 200 0

OPTN Appeal for Membership No Health Public Health Monitoring Private Sector 2 6 0

OPTN criteria reporting and disclosure No Health Public Health Monitoring Private Sector 1800 900 0

OPTN Reasons for Refusal No Health Public Health Monitoring Private Sector 34200 17100 0

OPTN Transplant to Prevent Organ Wastage No Health Public Health Monitoring Private Sector 390 195 0

OPTN Designated Transplant Program Requirements No Health Public Health Monitoring Private Sector 10 50 0

OPTN Appeal for Designation No Health Public Health Monitoring Private Sector 2 12 0

2011-04-25-04:00

0915-0193 201312-0915-002 0915
             
        "Uniform Data System"
             
          
        
The Uniform Data System (UDS) is the Bureau of Primary Health Care's annual reporting system for grantees. The UDS includes reporting requirements for grantees of the following programs: the Community Health Center program, the Migrant Health Center program, the Health Care for the Homeless program, and other 330 funded grantees. The UDS is the tool that is used for monitoring and evaluating health center performance, and for ensuring compliance with legislative mandates. 2015-02-28-05:00 Active Jodi Duckhorn 301 443-1984 No No No 1287 111438 254826

Uniform Data System No Health Health Care Services
2 EHR Question Yes Yes Fillable Fileable Form and instruction EHR Ques ATTACHMENT 121113.docx 1 UDS Manual Yes Yes Fillable Fileable Form and instruction UDS Manual 2012 V 25 with proposed 2013 changesCDHN.doc T7 T7 Yes Yes Fillable Fileable Form and instruction T7.doc T6B T6B Yes Yes Fillable Fileable Form and instruction T6B.doc App D App D Yes Yes Fillable Fileable Form and instruction APPENDIX D 2012_ELCD 92513.docx T4 T4 Yes Yes Fillable Fileable Form and instruction T4.doc 1 2014 Tables Yes Yes Fillable Fileable Form and instruction UDSTables2014_draft.docx T6A T6A Yes Yes Fillable Fileable Form and instruction T6A.doc
Private Sector 1287 111438 254826

2013-12-19-05:00

0915-0204 201306-0915-004 0915
             
        "HEAL Program:  Physician's Certification of Borrower's Total and Permanent Disability"
             
          
        
The forms certifies that the HEAL borrower meets the total and permanent disability requirements for cancellation of the obligation to repay HEAL student loans. The information collected on the certification and disability form is essential for proper administration of the HEAL program. 2016-09-30-04:00 Active Jodi Duckhorn 301 443-1984 No No No 90 23 0

HEAL Program: Physician's Certification of Borrower's Total and Permanent Disability No Health Health Care Services
1 HEAL Form 539-Disability Yes No Fillable Printable Form and instruction form539.doc
Private Sector 90 23 0

2013-09-17-04:00

0915-0212 201206-0915-002 0915
             
        "Voluntary Partner Surveys to Implement Executive Order 12862 in the Health Resources and Services Administration"
             
          
        
This generic project clearance allows HRSA to conduct voluntary customer satisfaction surveys of its partners to assess strengths and weaknesses in program services and products. Examples of such surveys include satisfaction with technical assistance provided to grantees, in class evaluations of training sessions, and satisfaction with information services. 2015-07-31-04:00 Active Jodi Duckhorn 301 443-1984 No No No 52250 5375 0

Bullying Prevention Training Modules Feedback Forms No Health Health Care Services
D Form D Follow-Up Form For Community Event Participant 7-17 Yes Yes Fillable Fileable Form and instruction Form D Follow-Up Form For Community Event Participant 7-17.docx C Form C For participants in Community_Events_7-17 Yes Yes Fillable Fileable Form and instruction Form C For participants in Community_Events_7-17.docx A Form A For Participants in the Bullying Prevention Modules Training 7 17 Yes Yes Fillable Fileable Form and instruction Form A For Participants in the Bullying Prevention Modules Training 7 17.docx B Form B Follow-Up Form For Participants in the Bullying Prevention Training Module 7-17 Yes Yes Fillable Fileable Form and instruction Form B Follow-Up Form For Participants in the Bullying Prevention Training Module 7-17.docx
Individuals or Households 700 175 0

National Health Service Corps (NHSC) Virtual Job Fair Customer Feedback No Health Public Health Monitoring
2 Participant Feedback Yes Yes Fillable Fileable Form and instruction Survey - Participant Feedback.pdf 1 Site Feedback Yes Yes Fillable Fileable Form and instruction Survey - Site Feedback.pdf
Individuals or Households 48 11 0

NHSC Virtual Job Fair Customer Feedback No Health Public Health Monitoring
2 Participant Survey Yes Yes Fillable Fileable Form and instruction NHSC Virtual Job Fair Follow Up - Participant Survey.pdf 1 Site Feedback Yes Yes Fillable Fileable Form and instruction NHSC Virtual Job Fair Follow Up - Site Survey.pdf
Individuals or Households 48 10 0

Primary Care Faculty Development Initiative No Health Public Health Monitoring
1 PCFDI Yes Yes Fillable Fileable Form 3PCFDI Post Program Survey.docx
Individuals or Households 36 6 0

MIECHV TACC Needs Assessment Survey No Health Illness Prevention
1 TACC Needs Assessment Yes Yes Fillable Fileable Form and instruction MIECHV TACC Needs Assessment Survey_12 20 12docx.docx
State, Local, and Tribal Governments 56 14 0

MAPP Satisfaction Survey No Health Immunization Management
1 NACCHO MAPP training satisfaction survey Yes Yes Fillable Fileable Form NACCHO HRSA MAPP Satisfaction Survey Final 1 31 13.docx
Individuals or Households 65 20 0

Customer Satisfaction Feedback of MIECHV Post-Award Grant Monitoring Process No Health Illness Prevention
1 customer satisfaction survey Yes Yes Fillable Fileable Form and instruction DHVECS Customer Satisfaction Feedback Tool.docx
State, Local, and Tribal Governments 112 28 0

HRSA Poison Help Campaign No Health Immunization Management
1 Moderator's Guide Yes Yes Paper Only Form and instruction Moderator Guide for English Speaking.docx
Individuals or Households 48 72 0

Technical Assistance provided to Ryan White HIV/AIDS Program Grantees No Health Public Health Monitoring
1 Comprehensive Site Visit Yes Yes Fillable Fileable Form Baseline & Follow-up Survey - (Comprehensive Site Visit).pdf 2 non-comprehensive site visit Yes Yes Fillable Fileable Form Baseline & Follow-up Survey (Non-Comprehensive Site Visit....pdf
Private Sector 156 26 0

CAREWare customer/user satisfaction No Health Public Health Monitoring
1 AREWare customer/user satisfaction Yes Yes Fillable Fileable Form and instruction CW Survey 1-14-14.pdf
State, Local, and Tribal Governments 2000 340 0

2012-07-16-04:00

0915-0230 201108-0915-001 0915
             
        "NHSC Recruitment and Retention Assistance Application"
             
          
        
The National Health Service Corps (NHSC) Recruitment and Retention Assistance Site Application is used for determining the eligibility of federally approved clinical practice sites to employ NHSC health professionals, and to verify current site needs to assign NHSC health professionals. 2014-10-31-04:00 Active Carla Haddad Carla.Haddad@hrsa.hhs.gov 301 443-0165 No No No 3000 1500 0

NHSC Recruitment and Retention Assistance Application No Health Health Care Services
Yes No Printable Only Instruction NHSC Site Application_Users Guide_07252011.zip 1 NHSC Site Application Yes Yes Fillable Fileable Form NHSC Site Application_screenshots_07252011.doc
Private Sector 3000 1500 0

2011-10-31-04:00

0915-0232 201112-0915-003 0915
             
        "National Health Service Corps Site Survey"
             
          
        
The National Health Service Corp Site Survey, formerly known as the Uniform Data System (UDS) Report, will establish continuity for Bureau supported grant/non-grant health care delivery sites. The collection of client and services data from non-grant suported sites will facilitate mandated reporting for NHSC activities. 2015-04-30-04:00 Active Afabwaje Jatau AJatau@hrsa.gov 301 443-1435 No No No 1200 32400 105000

National Health Service Corps Site Survey No Health Health Care Services
Form 1 NHSC Site Survey Yes Yes Fillable Fileable Form and instruction NHSC Site Survey_12022011.docx
Private Sector 1200 32400 105000

2012-04-10-04:00

0915-0247 201103-0915-001 0915
             
        "Children's Hospital Graduate Medical Eduction Program"
             
          
        
The Healthcare Research and Quality Act of 1999 amended the Public Health Service Act to establish a new program to support graduate medical education in children's hospitals. Children's hospitals will be requested to submit information reporting the number of full-time equivalent residents applying for training programs. This will determine the amount of direct and indirect expense payments. 2014-06-30-04:00 Active Nidhi Singh Nidhi.Singh@hrsa.hhs.gov 301 443-0371 No Yes No 60 3730 0

Children's Hospital Graduate Medical Eduction Payment Program No Health Health Care Services
HRSA_CHGME_99-5 HRSA_CHGME_99-5 http://bhpr.hrsa.gov/childrenshospitalgme/apply.htm Yes Yes Fillable Fileable Form and instruction hrsaform995_1-12-11.pdf HRSA_CHGME_99-3 HRSA_CHGME_99-3 http://bhpr.hrsa.gov/childrenshospitalgme/apply.htm Yes Yes Fillable Fileable Form and instruction hrsaform993_1-12-11.pdf 4 HRSA_CHGME_99-4 Yes Yes Fillable Fileable Form and instruction HRSA 99-4_with_ACA_changes.xlsx 1-2 HRSA_CHGME_99-1-2 Yes Yes Fillable Fileable Form and instruction HRSA 99-1and 99-2_with_ACA_changes.xlsx HRSA_CHGME_99 HRSA_CHGME_99 http://bhpr.hrsa.gov/childrenshospitalgme/apply.htm Yes Yes Fillable Fileable Form and instruction hrsaform99_1-12-11.pdf
Private Sector 60 3730 0

2011-06-27-04:00

0915-0253 201012-0915-003 0915
             
        "Ryan White HIV/AIDS Program Data Report Form (formerly CADR System)"
             
          
        
This is an extension request to continue using the Ryan White HIV/AIDS Program Data Report for the collection of service and client data. The Data Report was initially created in 1999 by HRSA's HIV/AIDS Bureau, and underwent revisions to incorporate the legislative changes that occurred in 2006. The information collected is used to assess the status of existing HIV-related service delivery systems and the need for service expansion. 2014-03-31-04:00 Active Nidhi Singh Nidhi.Singh@hrsa.hhs.gov 301 443-0371 No No No 2647 86766 0

Ryan White HIV/AIDS Program Data Report Form No Health Public Health Monitoring
1 Ryan White HIV/AIDS Program Data Report Yes Yes Fillable Fileable Form 2010_RDR_Form.doc
Private Sector 2647 86766 0

2011-03-14-04:00

0915-0278 201301-0915-001 0915
             
        "NHSC Travel Request Worksheet"
             
          
        
The National Health Service Corps (NHSC) Travel Request Worksheet (TRW) is used for pre-employment site visits and relocation to a NHSC authorized site for the purpose of securing employment to fulfill the NHSC service commitment. The form is utilized for the authorized travel for NHSC clinicians. 2016-02-29-05:00 Active Jodi Duckhorn 301 443-1984 No No No 360 24 0

NHSC Travel Request Worksheet No Health Health Care Services
1 Travel Request Worksheet Yes Yes Fillable Fileable Form Updated-NHSC Travel Form 0278 Form 11-2012.doc
Individuals or Households 360 24 0

2013-02-08-05:00

0915-0281 201306-0915-005 0915
             
        "AIDS Education and Training Centers (AETCs)"
             
          
        
The AETCs were developed to provide targeted, multidisciplinary training to the health care professionals who provide clinical and support services under the Ryan White Care Act. At present, there are 11 regional centers and 4 cross-cutting national centers. 2016-09-30-04:00 Active Jodi Duckhorn 301 443-1984 No No No 128868 9949 0

AIDS Education and Training Centers Participation Information Form (PIF) No Health Health Care Services
Yes Yes Printable Only Instruction AETC Manual revised 2010.doc 1 Participant Information Form Yes Yes Fillable Fileable Form HRSA AETC_PIF.doc
Individuals or Households 114423 8010 0

AIDS Education Training Centers Event Record (ER) No Health Health Care Services
Yes Yes Printable Only Instruction AETC Manual revised 2010.doc 1 Event Record Yes Yes Fillable Fileable Form HRSA AETC_ER.doc
Private Sector 14445 1939 0

2013-09-17-04:00

0915-0285 201312-0915-005 0915
             
        "The Health Center Program Application Forms"
             
          
        
Health Center Program forms are critical to the Program grant and non-grant award process, as well as to Program oversight and monitoring activities. These forms are used by health centers to request funding under Section 330 of the Public Health Service (PHS) Act, change their scope of project and become designated as Look-Alikes. Over 1,200 health centers deliver comprehensive, high quality, cost-effective primary health care to America's most vulnerable populations. 2016-09-30-04:00 Active Jodi Duckhorn 301 443-1984 No Yes No 32640 45015 0

General Information Worksheet No Health Illness Prevention
1 General Information Worksheet Yes Yes Fillable Fileable Form 01. Form 1A - General Information Worksheet.doc
Private Sector 1700 3400 0

Funding Request Summary No Health Illness Prevention
1B Funding Request Summary Yes Yes Fillable Fileable Form 02. Form 1B - BPHC Funding Request Summary.docx
Private Sector 400 400 0

Documents on File No Health Illness Prevention
1C Documents on File Yes Yes Fillable Fileable Form 03. Form 1C - Documents on File.doc
Private Sector 650 650 0

Staffing Profile No Health Illness Prevention
2 Staffing Profile Yes Yes Fillable Fileable Form 04. Form 2 - Staffing Profile.doc
Private Sector 1600 3200 0

Income Analysis No Health Illness Prevention
3 Income Analysis Yes Yes Fillable Fileable Form 05. Form 3 - Income Analysis.doc
Private Sector 1600 4800 0

Community Characteristics No Health Illness Prevention
4 Community Characteristics Yes Yes Fillable Fileable Form 06. Form 4 - Community Characteristics.doc
Private Sector 650 650 0

Services Provided No Health Illness Prevention
5a Services Provided Yes Yes Fillable Fileable Form 07. Form 5A - Services Provided.doc
Private Sector 1600 1600 0

Service Sites No Health Illness Prevention
5b Service Sites Yes Yes Fillable Fileable Form 08. Form 5B - Service Sites.doc
Private Sector 1600 1600 0

Other Activities/Locations No Health Illness Prevention
5c other activities/locations Yes Yes Fillable Fileable Form 09. Form 5C - Other ActivitiesLocations.doc
Private Sector 1600 800 0

Current Board Member Characteristics No Health Illness Prevention
6a Current Board Member Characteristics Yes Yes Fillable Fileable Form 10. Form 6A - Current Board Members Characteristics.doc
Private Sector 1600 1600 0

Request for Waiver of Governance Requirements No Health Illness Prevention
6b Request for waiver of governance requirements Yes Yes Fillable Fileable Form 11. Form 6B - Request for Waiver of Governance Requirements.doc
Private Sector 150 150 0

Health Center Agreements No Health Illness Prevention
8 Health Center Agreements Yes Yes Fillable Fileable Form 12. Form 8 - Health Center Agreements.doc
Private Sector 250 250 0

Need for Assitance Worksheet No Health Illness Prevention
9 Need for Assistance Worksheet Yes Yes Fillable Fileable Form 13. Form 9 - Need of Assistance Worksheet.doc
Private Sector 650 3250 0

Annual Emergency Preparedness Report No Health Illness Prevention
10 Annual Emergency Preparedness Report Yes Yes Fillable Fileable Form 14. Form 10 - Annual Emergency Preparedness Report.doc
Private Sector 1600 1600 0

Clinical Performance Measures No Health Illness Prevention
1 Clinical Performance Measures Yes Yes Fillable Fileable Form 16. Clinical Performance Measures.doc
Private Sector 1600 3200 0

Organization Contacts No Health Illness Prevention
12 Organization Contacts Yes Yes Fillable Fileable Form 15. Form 12 - Organization Contacts.doc
Private Sector 1600 800 0

Financial Performance Measures No Health Illness Prevention
1 Financial Performance Measures Yes Yes Fillable Fileable Form 17. Financial Performance Measures.doc
Private Sector 1600 1600 0

Checklist for Adding New Service No Health Illness Prevention
1 Checklist for adding new service Yes Yes Fillable Fileable Form 20. Checklist for Adding New Service.docx
Private Sector 700 1400 0

Checklist for Deleting Existing Service No Health Illness Prevention
1 Checklist for deleting existing service Yes Yes Fillable Fileable Form 21. Checklist for Deleting Existing Service.docx
Private Sector 700 1400 0

Checklist for Replacing Existing Service Delivery Site No Health Illness Prevention
1 Checklist for replacing existing service delivery site Yes Yes Fillable Fileable Form 22. Checklist for Replacing Existing Service Delivery Site.docx
Private Sector 700 1400 0

Checklist for Adding a new Service Delivery Site No Health Illness Prevention
1 Checklist for Adding a New Service Delivery Site Yes Yes Fillable Fileable Form 18. Checklist for Adding a New Service Delivery Site.docx
Private Sector 700 1400 0

Checklist for Deleting Existing Service Delivery Site No Health Illness Prevention
1 Checklist for Deleting Existing Service Delivery Site Yes Yes Fillable Fileable Form 19. Checklist for Deleting Existing Service Delivery Site.docx
Private Sector 700 1400 0

Proposal Cover Page No Health Illness Prevention
1 Proposal Cover Page Yes Yes Fillable Fileable Form 23. Proposal Cover Page.doc
Private Sector 400 400 0

Project Cover Page No Health Illness Prevention
1 Project Cover Page Yes Yes Fillable Fileable Form 24. Project Cover Page.docx
Private Sector 400 400 0

Equipment List No Health Illness Prevention
1 Equipment List Yes Yes Fillable Fileable Form 25. Equipment List.docx
Private Sector 400 400 0

Other Requirements for Sites No Health Illness Prevention
1 Other Requirements for Sites Yes Yes Fillable Fileable Form 26. Other requirement for sites.docx
Private Sector 400 200 0

Checklist for Adding a New Target Population No Health Illness Prevention
1 checklist for adding a new target population Yes Yes Fillable Fileable Form 27. Checklist for Adding a New Target Population.docx
Private Sector 50 50 0

Increased Demand for Services No Health Illness Prevention
1 Increased demand for services Yes Yes Fillable Fileable Form 28. Increased Demand for Services.doc
Private Sector 1200 1200 0

Funding Sources No Health Illness Prevention
1 Funding Sources Yes Yes Fillable Fileable Form 31. Funding Sources.docx
Private Sector 400 200 0

Project Qualification Criteria No Health Illness Prevention
1 Project Qualification Criteria Yes Yes Fillable Fileable Form 32. Project Qualification Criteria.doc
Private Sector 400 400 0

Implementation Plan No Health Illness Prevention
1 Implementation Plan Yes Yes Fillable Fileable Form implementation plan.doc
Private Sector 400 1200 0

Project Work Plan No Health Illness Prevention
1 Project Work Plan Yes Yes Fillable Fileable Form 33. Project Work Plan form.docx
Private Sector 100 400 0

Verification Checklist No Health Illness Prevention
1 Verification Checklist Yes Yes Fillable Fileable Form 34. Verification Checklist.doc
Private Sector 200 100 0

EHR Readiness Checklist No Health Illness Prevention
1 EHR Readiness Checklist Yes No Fillable Fileable Form 35. EHR Readiness Checklist.docx
Private Sector 50 25 0

Look Alike Budget No Health Illness Prevention
1 Look Alike Budget Yes Yes Fillable Fileable Form 36. Look alike budget.doc
Private Sector 100 100 0

Oamp;E Supplemental No Health Illness Prevention
1 O&E Supplemental Yes Yes Fillable Fileable Form 37. Outreach and Enrollment Supplemental form.docx
Private Sector 1295 1295 0

Oamp;E Progress Report No Health Illness Prevention
1 O&E Progress Report Yes Yes Fillable Fileable Form 39. OE Progress_Report.docx
Private Sector 1295 1295 0

Supplemental Line Item Budget No Health Illness Prevention
1 Supplemental Line Item Budget Yes Yes Fillable Fileable Form and instruction 38. Supplemental Line_Item_Budget.docx
Private Sector 1600 800 0

2014-01-02-05:00

0915-0290 201112-0915-001 0915
             
        "National Survey of Organ Donation Attitudes and Practices"
             
          
        
The Division of Transplantation (DoT), Healthcare Systems Bureau, Health Resources and Services Administration (HRSA) is planning to conduct a telephone survey of public knowledge, perceptions, opinion, and behaviors related to organ donation. The proposed study will identify current organ donation views and practices of the American public and various population subgroups using a survey instrument measuring issues such as public knowledge about and attitudes toward organ donation, public commitment to or willingness to donate, impediments to public willingness to donate, and attitudes toward living donation, donation practices, policy issues, allocation policy, presumed consent, and financial incentives for donation. Two national surveys using nearly identical survey instruments to identify public views and behaviors related to organ donation were conducted in 1993 and 2005, and results from this study will be utilized to track changes over time. 2015-03-31-04:00 Active Gerta Bardhoshi GBardhoshi@hrsa.gov 301 443-1129 No No No 3250 975 0

National Survey of Organ Donation Attitudes and Practices No Health Public Health Monitoring
1 Revised Survey No Printable Only Form and instruction Survey with OMB changes (face+hands, new ethnicity categories) 02-28-12.doc
Individuals or Households 3250 975 0

2012-03-23-04:00

0915-0292 201308-0915-004 0915
             
        "Black Lung Clinics Program Database"
             
          
        
The Black Lung Clinics Program was designed to improve the health status of coal workers by providing services to minimize the effects of respiratory and pulmonary impairments of coal miners. The Black Lung Program Database is the reporting system for the Black Lung Clinic Program grantees. 2016-09-30-04:00 Active Jodi Duckhorn 301 443-1984 No No No 15 150 0

Black Lung Clinics Program Database No Health Health Care Services
1 PIMS Measures Yes Yes Fillable Fileable Form Black Lung PIMS measures.pdf
Private Sector 15 150 0

2013-09-20-04:00

0915-0293 201108-0915-003 0915
             
        "Free Clinics FTCA Program Application"
             
          
        
The Free Clinics FTCA program application is used to determine if the free clinic volunteer health professionals meet the statutory requirements for deeming the health care professional as a Federal employee for the purposes of Federal Tort Claims Act (FTCA) medical malpractice protection. If the requirements of the Act are met, the related free clinic can be sponsored to be "deemed" a federal employee for the purpose of FTCA medical malpractice coverage. 2014-12-31-05:00 Active Carla Haddad Carla.Haddad@hrsa.hhs.gov 301 443-0165 No No No 200 2800 0

Free Clinics FTCA Program Application No Health Health Care Services
Yes No Printable Only Instruction pal201109 - 2012 Application PAL.pdf Free Clinics 1 Free Clinics Application Yes Yes Fillable Fileable Form 2012 deemingapplication.xls
Private Sector 200 2800 0

2011-12-12-05:00

0915-0294 201102-0915-002 0915
             
        "HRSA AIDS Drug Assistance Quarterly Report"
             
          
        
The HRSA AIDS Drug Assistance Program provides medications for the treatment of HIV disease to States and Territories. As part of the funding requirement, ADAP grantees submit quarterly reports that provide information on how grant funds are expended and on utilization of services. 2014-03-31-04:00 Active Amanda Cash amanda.cash@hrsa.hhs.gov 301 443-0208 No No No 228 428 0

HRSA AIDS Drug Assistance Quarterly Report No Health Public Health Monitoring
Yes No Fillable Fileable Instruction C - AQR Instructions_revised_3.18.11.docx 1 ADAP Quarterly Report Yes Yes Fillable Fileable Form B - AQR Form.doc
State, Local, and Tribal Governments 228 428 0

2011-03-24-04:00

0915-0295 201311-0915-001 0915
             
        "Grant Reviewer Recruitment Form"
             
          
        
This web based grant reviewer form is used to recruit reviewers for HRSA grant and cooperative agreement programs. The form collects reviewer information that is used to select and assign grant reviewers to objective review committees. 2016-12-31-05:00 Active Jodi Duckhorn 301 443-1984 No No No 5250 1707 0

Grant Reviewer Recruitment Form No Health Illness Prevention
1 DIR Grant Reviewer Recruitment Form Yes Yes Fillable Printable Form RRM Screenshots.docx
Individuals or Households 5250 1707 0

2013-12-24-05:00

0915-0298 201210-0915-002 0915
             
        "Maternal and Child Health Bureau Performance Measures for Discretionary Grants"
             
          
        
This consolidated set of performance measures collects information from public or private agencies or organizations engaged in demonstrations, research, training, or other projects that receive funding from the Special Projects of Regional and National Significane (SPRANS) and Community Integrated Service Systems (CISS) federal and discretionary grant programs, and other categorical discretionary grant programs. 2016-03-31-04:00 Active Jodi Duckhorn 301 443-1984 No No No 900 37062 0

Maternal and Child Health Bureau Performance Measures for Discretionary Grants No Health Health Care Services
1 Detail Sheets Yes Yes Fillable Fileable Form and instruction Attach B - Detail Sheets.doc 3 ADE Yes Yes Fillable Fileable Form and instruction Attach D - ADE.docx 2 Demographic Forms Yes Yes Fillable Fileable Form and instruction Attach C -REV Fin and Demo Forms.doc
State, Local, and Tribal Governments 900 37062 0

2013-03-20-04:00

0915-0301 201206-0915-004 0915
             
        "The Nursing Scholarship Program"
             
          
        
The Nursing Scholarship Program's purpose is to provide scholarships to nursing students in exchange for a service commitment at an eligible health facility with a critical shortage of nurses. Under this program, students seeking to become registered nurses are offered the opportunity to enter into a contractural agreement under which HHS agrees to pay the total school tuition required fees, and a stipend for living expenses. 2015-08-31-04:00 Active Jodi Duckhorn 301 443-1984 No No No 5700 10200 0

The Nursing Scholarship Program No Health Health Care Services
3a In-Service Monitoring Initial Verification of Employment Yes Yes Fillable Fileable Form and instruction Attachment G - IN-Service Monitoring - Initial Verification of Employment Form.doc 2b In-School Monitoring - School Verification form Yes Yes Fillable Fileable Form and instruction Attachment F - IN-School Monitoring - School Verification Form.pdf 1c Application contract Yes Yes Fillable Fileable Form Attachment D - Application - NSP Contract 2012-2013.pdf 2a In-school Monitoring DCW form Yes Yes Fillable Fileable Form and instruction Attachment E - IN-School Monitoring - NSP DCW Form Screenshots.docx 1b Application Program Guidance Yes Yes Printable Only Form and instruction Attachment C - Application Program Guidance.pdf 1a application screenshots Yes Yes Fillable Fileable Form and instruction Attachment B - Application Screenshots.docx 3b In-Service BCRS Verification Form Yes Yes Fillable Fileable Form and instruction Attachment H - In-Service Verification Form; BCRS.docx
Individuals or Households 5700 10200 0

2012-08-31-04:00

0915-0304 201307-0915-001 0915
             
        "Ryan White CARE Act Title I Minority AIDS Initiative (MAI) Report: Title I Report"
             
          
        
The Part A Minority AIDS Initiative Report is used to collect performance data from Ryan White Part A grantees receiving funds under the Part F - Minority AIDS Initiative (MAI). These funds support activities to evaluate and address the disproportionate impact of HIV/AIDS on, and the disparities in access, treatment, and outcomes in communities of color Part A Eligible Metropolitan Areas (EMAs) and Transitional Grant Areas (TGAs). 2016-09-30-04:00 Active Jodi Duckhorn 301 443-1984 No No No 106 2533 0

Ryan White CARE Act Title I Minority AIDS Initiative Report: Title I Report No Health Health Care Services
1 screen shots Yes Yes Fillable Fileable Form Attachment A - Screen Shots of Sample Web Form from Part A MAI Report Web Application.doc
State, Local, and Tribal Governments 106 2533 0

2013-09-03-04:00

0915-0307 201102-0915-004 0915
             
        "HIV/AIDS Bureau Core Medical Services Waiver"
             
          
        
The Ryan White HIV/AIDS Treatment Extension Act of 2009 requires that grantees receiving funds under Parts A, B, and C expend 75% of funding on core medical services, including anitretroviral drugs, for individuals with HIV/AIDS identified and eligible under the legislation. Sections of the Act permit a waiver with respect to the required portion of funding for core medical services. In order to request a waiver, grantees must submit a request and provide supporting information and documentation along with the grant application to ensure compliance with the Act. 2014-04-30-04:00 Active Gerta Bardhoshi GBardhoshi@hrsa.gov 301 443-1129 No No No 10 65 0

HIV/AIDS Bureau Core Medical Services Waiver No Health Health Care Services
Waiver_Definitions Waiver_Definitions Yes Yes Printable Only Form and instruction Waiver_definitions_Updated.doc
State, Local, and Tribal Governments 10 65 0

2011-04-18-04:00

0915-0309 201306-0915-006 0915
             
        "Health Care and Other Facilities Project Status Update Form"
             
          
        
HRSA is requesting approval for the Health Care and Other Facilities Project Status Update Form. This form will allow for the standardized and electronic collection of information that will allow HRSA to monitor and verify its grantees' progress towards completion of their projects. 2016-08-31-04:00 Active Jodi Duckhorn 301 443-1984 No No No 1117 559 0

Health Care and Other Facilities Project Status Update Form- Construction Related No Health Health Care Services
0309A Health Care and Other Facilities Project Status Update Form-Construction-related Yes Yes Fillable Fileable Form Progress Report Form-0309.pdf
Private Sector 800 400 0

Health Care and Other Facilities Project Status Update Form- Equipment Only No Health Health Care Services
0309B Health Care and Other Facilities Project Status Update Form-Equipment Only Yes Yes Fillable Fileable Form Progress Report Form-0309.pdf
Private Sector 317 159 0

2013-08-06-04:00

0915-0310 201312-0915-004 0915
             
        "Stem Cell Therapeutic Outcomes Database"
             
          
        
The Stem Cell Therapeutic and Research Act of 2005 provides for the collection and maintenance of human blood stem cells for the treatment of patients and research. HRSA's Healthcare Systems Bureau has established the Stem Cell Therapeutic Outcomes Database. Operation of this database necessitates certain record keeping and reporting requirements in order to perform the functions related to hematopoietic stem cell transplantation under contract to the HHS. The Act requires the Secretary to contract for the establishment and maintenance of information related to patients who have received stem cell therapeutic products and to do so using a standardized, electronic format. Data is collected from transplant centers by the Center for International Blood and Marrow Transplant Research and is used for ongoing analysis of transplant outcomes. HRSA uses the information in order to carry out its statutory responsibilities. Information is needed to monitor the clinical status of transplantation and to provide the Secretary of HHS with an annual report of transplant center-specific survival data. 2017-01-31-05:00 Active Jodi Duckhorn 301 443-1984 No No No 53400 52260 0

Stem Cell Therapeutic Outcomes Database (Pre-TED Form 2400) No Health Consumer Health and Safety
1 Pre-TED Form 2400 Yes Yes Fillable Fileable Form 1-Form_2400 pre-TED R4+[1].pdf
Private Sector 7600 7600 0

Stem Cell Therapeutic Outcomes Database (Product Form) No Health Consumer Health and Safety
3 INF Yes Yes Fillable Fileable Form 2-FINAL 2006-Product Form (INF) r3.doc 1 IDM Yes Yes Fillable Fileable Form 2-FINAL 2004-Product Form (IDM) r4.doc Yes No Printable Only Instruction 2004 id-markers-instructi.pdf Yes No Printable Only Instruction 2006 Infusion form-inst.pdf 2 HLA Yes Yes Fillable Fileable Form 2-Form_2005 HLA R5+.pdf Yes Yes Printable Only Instruction 2-Instructions 2005 HLA Typing_v2.0.pdf
Private Sector 5800 5800 0

Stem Cell Therapeutic Outcomes Database (Post-Trans) No Health Consumer Health and Safety
1 Post-TED Yes Yes Fillable Fileable Form 3-Form 2450 PostTED r3.pdf Yes No Printable Only Instruction 2450 post-ted-instruction.pdf
Private Sector 40000 38860 0

2014-01-27-05:00

0915-0311 201312-0915-001 0915
             
        "Office for the Advancement of Telehealth (OAT) Telehealth Outcome Measures"
             
          
        
The data collection tool extracts valuable information on services provided that are critical to the mission of HRSA and provides valid and complete information about methods used to measure the impact of the telehealth program on improving access to healthcare services for residents of communities that did not have such services locally before the program. Projects are able to measure the impact of the telehealth program on hospitalization rates and emergency room visit rates per year for patients receiving disease management services for diabetes, congestive heart failure, stroke and other chronic diseases, as well for patients receiving home care/home monitoring services. Projects can measure impact of the telehealth program on controlling blood glucose levels in diabetic patients and can assure the impact of the telehealth program improving efficiency of health care. In addition, projects also measure the impact of the telehealth program on reducing medical errors and collect data to measure other clear outcomes. 2017-01-31-05:00 Active Jodi Duckhorn 301 443-1984 No No No 1400 9800 0

Performance Improvement Measurement System for the Office for the Advancement of Telehealth No Health Health Care Services
Yes Yes Printable Only Instruction OAT PIMS Instructions.doc 1 OAT Grantee Tutorial for PIMS login Yes Yes Fillable Printable Form OAT Grantee Tutorial for PIMS login.pdf
Private Sector 1400 9800 0

2014-01-30-05:00

0915-0313 201308-0915-001 0915
             
        "Children's Hospital Graduate Medical Education Program Annual Report"
             
          
        
The Children's Hospital BME Support Reauthorization Act of 2006 (P.L. 109-307) requires an annual report and a special Report to Congress for all hospitals participating in the CHGME Payment Program. The legislation requires an annual report that includes information for the residency training academic year completed immediately prior to each fiscal year for which the hospital applies for funds. The reauthorizing statute also requires a Report to Congress describing the results of the program and making recommendations for program improvement. 2016-09-30-04:00 Active Jodi Duckhorn 301 443-1984 No No No 108 4558 0

Children's Hospital GME Annual Report Screeing Instrument No Health Consumer Health and Safety
1 Hospital Fianance Staff HRSA 100-1 Yes Yes Fillable Fileable Form and instruction HRSA 100-1 FY13.xlsm
Private Sector 54 562 0

CHGME Payment Program HRSA 100-2 and HRSA 100-3 Annual Report Forms No Health Consumer Health and Safety
Yes Yes Fillable Printable Other hrsaform1005_2013.pdf 100-2 HRSA 100-2 FY13 - Redesign Yes Yes Fillable Printable Form and instruction HRSA 100-2 FY13 - Redesign.xlsm Yes Yes Fillable Printable Other hrsaform1004_2013.pdf 100-3 HRSA 100-3_FY13 Yes Yes Fillable Printable Form and instruction HRSA 100-3_FY13.xlsm
Private Sector 54 3996 0

2013-09-16-04:00

0915-0314 201012-0915-005 0915
             
        "Nurse Faculty Loan Program (NFLP) Annual Operating Report"
             
          
        
HRSA provides funds to eligible institutions under the Nurse Faculty Loan Program (NFLP) to increase the number of qualified nursing faculty. The Annual Operating Report (AOR) is used to obtain NFLP loan activity information from institutions receiving funding for the purpose of monitoring and evaluating institutional performance, and for determining fiscal year awards. 2014-03-31-04:00 Active Nidhi Singh Nidhi.Singh@hrsa.hhs.gov 301 443-0371 No Yes No 150 1200 0

Nurse Faculty Loan Program Annual Operating Report No Health Health Care Services
NFLP-AOR1 NFLP-AOR Report Yes Yes Fillable Fileable Form and instruction NFLP AOR Form Modified FINAL.doc
Private Sector 150 1200 0

2011-03-24-04:00

0915-0318 201102-0915-003 0915
             
        "Ryan White HIV/AIDS Program Allocation and Expenditure Forms"
             
          
        
The Ryan White HIV/AIDS Treatment Modernization Act of 2006 requires grantees receiving funds under Parts A, B, and C to spend at least 75 percent of their grant funds on core medical services. Prior to the new law, no core set of medical services had been specified in the statute. The Allocation and Expenditure forms collect information necessary tn monitor grant funds and ensure compliance with the Act. 2014-03-31-04:00 Active Gerta Bardhoshi GBardhoshi@hrsa.gov 301 443-1129 No No No 1362 9546 0

Part A Allocation and Expenditures Forms No Health Health Care Services
Part A Expenditures Report and Checklist Part A Expenditures Report and Checklist Yes Yes Fillable Fileable Form Part A Expenditures Report.xls 1 Part A Allocations Report and Checklist Yes Yes Fillable Fileable Form Part A Allocations Report.xls Yes No Fillable Printable Instruction Instructions for PART A (with EHBs Instructions).doc
State, Local, and Tribal Governments 112 896 0

MAI report for Part A No Health Health Care Services
3 Part A Expenditures Report and Checklist Yes Yes Fillable Fileable Form Part A Expenditures Report.xls Yes No Fillable Printable Instruction Instructions for PART A (with EHBs Instructions).doc 2 Part A Allocations Report and Checklist Yes Yes Fillable Fileable Form Part A Allocations Report.xls
State, Local, and Tribal Governments 112 448 0

Part B Allocation and Expenditure forms No Health Health Care Services
2b Part B Expenditures Report Yes Yes Fillable Fileable Form Part B Expendiutres Report.xls 2a Part B Allocations Report Yes Yes Fillable Fileable Form Part B Allocations Report.xls Yes No Printable Only Instruction Instructions for PART B (with EHBs Instructions).doc
State, Local, and Tribal Governments 118 1416 0

MAI Report for Part B No Health Health Care Services
4a Part B Allocations Report Yes Yes Fillable Fileable Form Part B Allocations Report.xls 4b Part B Expenditures Report Yes Yes Fillable Fileable Form Part B Expendiutres Report.xls Yes No Printable Only Instruction Instructions for PART B (with EHBs Instructions).doc
State, Local, and Tribal Governments 118 472 0

Part C Allocation and Expenditure forms No Health Health Care Services
5a Part C Allocations Report and Checklist Yes Yes Fillable Fileable Form Part C Allocations Report.xls 5b Part C Expenditures Report and Checklist Yes Yes Fillable Fileable Form Part C Expenditures Report.xls Yes No Printable Only Instruction Instructions for PART C (with EHBs Instructions).doc
State, Local, and Tribal Governments 722 5054 0

Part D Allocation and Expenditure forms No Health Health Care Services
6a Part D Allocations Report Yes Yes Fillable Fileable Form Part D Allocations Report.xls 6b Part D Expenditures Report Yes Yes Fillable Fileable Form Part D Expenditures Report.xls Yes No Printable Only Instruction Instructions for PART D (with EHBs Instructions).doc
State, Local, and Tribal Governments 180 1260 0

2011-03-21-04:00

0915-0319 201103-0915-002 0915
             
        "Rural Health Community-Based Grant Program "
             
          
        
HRSA's Office of Rural Health Policy has developed a Performance Improvement and Measurement System (PIMS)for the collection of information on grant activities and performance measures for six rural health community-based grant programs. These grant programs provide support for sustaining and improving access to quality health care services in rural communities. 2014-08-31-04:00 Active Gerta Bardhoshi GBardhoshi@hrsa.gov 301 443-1129 No No No 281 1095 0

Rural Health Outreach Grant Program No Health Health Care Services
1 Rural Health Care Outreach Yes Yes Fillable Fileable Form and instruction Outreach Program PIMS Measures--FINAL.doc
Private Sector 111 361 0

Rural Health Network Development No Health Health Care Services
2 Rhnd Yes Yes Fillable Fileable Form and instruction Network Development Program PIMS Measures--FINAL.docx
Private Sector 49 135 0

Delta States Rural Development Network Grant Program No Health Health Care Services
3 Delta States Rural Development Network Yes Yes Fillable Fileable Form and instruction Delta States Program PIMS Measures--FINAL.doc
Private Sector 12 37 0

Small Health Care Provider Quality Improvement Grant Program No Health Health Care Services
4 Small Health Care Provider Quality Improvement Yes Yes Fillable Fileable Form and instruction Quality Program PIMS Measures--FINAL.docx
Private Sector 59 472 0

Network Development Planning Grant Program No Health Health Care Services
5 Network Development Planning Yes Yes Fillable Fileable Form and instruction Network Planning PIMS Measures--FINAL.docx
Private Sector 30 30 0

Rural Health Workforce Development Program No Health Health Care Services
6 rural Health Workforce Development Yes Yes Fillable Fileable Form and instruction Workforce Program PIMS Measures--FINAL.doc
Private Sector 20 60 0

2011-08-10-04:00

0915-0322 201307-0915-004 0915
             
        "State Offices of Rural Health TA Data Collection Form"
             
          
        
The purpose of this data collection is to provide HRSA/ORHP with standardized information on how well each SORH grantee is meeting the technical assistance needs of their States and rural communities. Consolidated data from the form provides quantitative information about technical assistance provided directly by the SORH grant program. Respondents are each of the 50 State Office of Rural Health. 2016-09-30-04:00 Active Jodi Duckhorn 301 443-1984 No No No 50 625 0

State Offices of Rural Health TA Data Collection Form No Health Health Care Services
1 TA Request Form Yes Yes Fillable Fileable Form and instruction SORH TA PIMS Screenshot.doc
State, Local, and Tribal Governments 50 625 0

2013-09-16-04:00

0915-0323 201101-0915-002 0915
             
        "HAB Client Level Reporting"
             
          
        
This is a request for the revision of the Client-Level Data Reporting System for the HIV/AIDS Bureau at the Health Resources and Services Administration that will be used to collect de-identified client-level data from grantees and service providers funded under the Ryan White HIV/AIDS Program. 2014-05-31-04:00 Active Nidhi Singh Nidhi.Singh@hrsa.hhs.gov 301 443-0371 No No No 4525 17975 0

HAB Client-Level Grantee Report No Health Health Care Services
1 Grantee Report Yes Yes Fillable Fileable Form and instruction B - 2010_RSR_Grantee_Report_Screenshots.doc
Private Sector 567 408 0

HAB Client-Level Data Collection System No Health Health Care Services Private Sector 0 0 0

HAB Client-Level Provider Report No Health Health Care Services
2 Service Provider Report Yes Yes Fillable Fileable Form and instruction C - 2010_Service_Provider_Form_Screenshots.doc
Private Sector 2080 4784 0

HAB Client Report Without Data Systems No Health Health Care Services Private Sector 56 5950 0

HAB Client Report With Data Systems No Health Health Care Services Private Sector 1822 6833 0

2011-05-25-04:00

0915-0324 201301-0915-002 0915
             
        "HRSA Environmental Information and Documentation (EID)"
             
          
        
The EID Checklist obtains information that is required to ensure compliance with the National Environmental Policy Act (NEPA) as specified under P.L. 91-190. HRSA will use this information along with overall program applications to determine eligibility for agency awards that support construction projects including acquisition of health information technology systems. 2016-03-31-04:00 Active Jodi Duckhorn 301 443-1984 Yes No No 1847 1385 0

HRSA NEPA Environmental Information and Documentation No Health Health Care Services
0915-0324 EID Yes Yes Fillable Fileable Form REVISED EID.docx
Private Sector 1847 1385 0

2013-03-25-04:00

0915-0327 201308-0915-006 0915
             
        "340B Drug Pricing Program Forms"
             
          
        
HRSA Office of Pharmacy Affairs (OPA) has a process for registering covered entities who choose to participate in the section 340B Drug Pricing Program. These entities must comply with the requirements of 340B (a)(5)(A) of the PHS Act. The 340B Drug Pricing Program forms allow entities to provide registration and certifying information and to determine eligibility for the progam. 2015-10-31-04:00 Active Jodi Duckhorn 301 443-1984 No Yes No 24464 14705 0

340B Program Registrations amp; Certifications for Disproportionate Share Hospitals No Health Health Care Services
3 GPO Form Yes Yes Fillable Fileable Form and instruction GPOform final(1) June 18.docx.updated4.5.docx 4 Public OWNERSHIP Revised Yes Yes Fillable Fileable Form and instruction Public OWNERSHIP Revised.pdf 1 1 340B Registration-DSH Yes Yes Fillable Fileable Form and instruction 1 340B Registration-DSH.docx 2 Cert state or local government Revised Yes Yes Fillable Fileable Form and instruction Cert state or local government Revised.pdf
Private Sector 330 660 0

340B Program Registrations amp; Certifications for Children's Hospitals No Health Health Care Services
1 2 340B Registration for Children's Hospitals Yes Yes Fillable Fileable Form and instruction 2 340B Registration for Children's Hospitals.docx 4 Public OWNERSHIP Revised Yes Yes Fillable Fileable Form and instruction Public OWNERSHIP Revised.pdf 3 Cert state or local government Revised Yes Yes Fillable Fileable Form and instruction Cert state or local government Revised.pdf 2 GPO FOrm No Yes Fillable Fileable Form and instruction GPOform final(1) June 18.docx.updated4.5.docx
Private Sector 12 24 0

Certification to Enroll DSH and Children's Hospitals' Outpatient facilities to 340B Program No Health Health Care Services
1 3 340B Registration-Outpatient Facility Revised Yes Yes Fillable Fileable Form and instruction 3 340B Registration-Outpatient Facility Revised.docx
Private Sector 606 303 0

Hospital Annual Recertification No Health Health Care Services
1 Recert-Crtical Access; Sole-community; Rural-Referral centers (Orphan Drug) Yes Yes Fillable Fileable Form and instruction Recert-Crtical Access; Sole-community; Rural-Referral centers (Orphan Drug).pdf 1 4 Hospital Recertification Yes Yes Fillable Fileable Form and instruction 4 Hospital Recertification.pdf 1 Recert Attestation Yes Yes Fillable Fileable Form and instruction Recertattestation.docx 1 Recert-Free standing (Orphan Drug) Yes Yes Fillable Fileable Form and instruction Recert-Free standing (Orphan Drug).pdf
Private Sector 4842 2421 0

340B Registration for all other covered entities No Health Health Care Services
1 5 340BRegistration-Covered Entities All Other Revised No Yes Fillable Fileable Form and instruction 5 340BRegistration-Covered Entities All Other Revised.docx
Private Sector 606 606 0

Annual Recertification for Family Planning No Health Health Care Services
1 FP Recertification Yes Yes Fillable Fileable Form and instruction 6 FP Recert.pdf
State, Local, and Tribal Governments 3879 1940 0

Annual Recertificaion for STD amp; TB No Health Health Care Services
2 7 TB Recert Yes Yes Fillable Fileable Form and instruction 7 TB Recert.pdf 1 7 STD Recert Yes Yes Fillable Fileable Form and instruction 7 STD Recert.pdf
State, Local, and Tribal Governments 2754 1377 0

Annual Recertification for Other Entities No Health Health Care Services
1 8 RW Recert Yes Yes Fillable Fileable Form and instruction 8 RW Recert.pdf
Private Sector 5681 2841 0

Administrative Change Form No Health Health Care Services
1 9 NewChangeFormProposalPaperversion Yes Yes Printable Only Form and instruction 9 NewChangeFormProposalPaperversion.docx 1 Online version Yes Yes Fillable Fileable Form and instruction 340B Participatant Change Request Revised.pdf
Private Sector 2500 1250 0

Contract Pharmacy Self Certification Form No Health Health Care Services
1 Contract Pharmacy Registrationform Revised Yes Yes Fillable Fileable Form and instruction Contract Pharmacy Registrationform Revised.pdf
Private Sector 2500 2500 0

Administrative Changes for Any Manufacturer No Health Health Care Services
1 340BManufacturerChangeForm Revised Yes Yes Fillable Fileable Form and instruction 340BManufacturerChangeForm Revised.pdf
Private Sector 350 175 0

340B Program Registrations amp; Certifications for Free Standing Cancer Hospitals No Health Health Care Services
1 12 340B Registration Free Standing Cancer Hospitals (Orphan Drug) Yes Yes Fillable Fileable Form and instruction 12 340B Registration Free Standing Cancer Hospitals (Orphan Drug).docx
Private Sector 8 16 0

340B Program Registrations amp; Certifications for Rural Referral Hospitals No Health Health Care Services
1 13+14 340B Registration Rural Referral Centers and Sole Community Hospitals (Orphan Drug) Yes Yes Fillable Fileable Form and instruction 13+14 340B Registration Rural Referral Centers and Sole Community Hospitals (Orphan Drug).docx
Private Sector 48 96 0

340B Program Registrations amp; Certifications for Sole Community Hospitals No Health Health Care Services
1 13+14 340B Registration Rural Referral Centers and Sole Community Hospitals (Orphan Drug) Yes Yes Fillable Fileable Form and instruction 13+14 340B Registration Rural Referral Centers and Sole Community Hospitals (Orphan Drug).docx
Private Sector 60 120 0

340B Program Registrations and Certifications for Critical Access Hospitals No Health Health Care Services
1 11 340B Registration Critical Access Hospitals (Orphan Drug) Yes Yes Fillable Fileable Form and instruction 11 340B Registration Critical Access Hospitals (Orphan Drug).docx
Private Sector 88 176 0

Pharmaceutical Pricing Agreement No Health Health Care Services Private Sector 200 200 0

2013-09-03-04:00

0915-0334 201308-0915-005 0915
             
        "Countermeasures Injury Compensation Program (CICP)"
             
          
        
The Health Resources and Services Administration (HRSA) is requesting approval for the information collection reqirements contained in the the Countermeasures Injury Compensation Program. The Countermeasures Injury Compensation Program is designed to provide compensation to individuals for serious physical injuries or deaths from pandemic, epidemic, or security countermeasures identified in declarations issued by the Secretary pursuant to section 319F-3(b) of the Public Health Service Act. 2016-09-30-04:00 Active Jodi Duckhorn 301 443-1984 No No No 260 1327 0

Countermeasures Injury Compensation Program Request Package No Health Immunization Management
1 Request for Benefits Form and Supporting Documentation Yes Yes Fillable Printable Form and instruction 1 Final CICP Request Form (with color).docx
Individuals or Households 100 1100 0

Authorization for Use or Disclosure of Health Information Form No Health Immunization Management
1 Authorization for Use or Disclosure of Health Information Form Yes Yes Fillable Printable Form and instruction 2 CICP Authorization Form.doc
Individuals or Households 100 200 0

Additional Documentation and Certification No Health Immunization Management
1 Additional Documentation and Certification Yes Yes Paper Only Form 3 Additional Documentation Form.pdf
Individuals or Households 30 23 0

Benefits Package and Supporting Documentation No Health Immunization Management
1 Certification of Status for Death Benefit - Alternative Calculation (Attachment 2) Yes Yes Paper Only Form and instruction Certification of Status for Death Benefit - Alternative Calculation (Attachment 2).docx 2 Certification of Status for Death Benefit - Standard Calculation (Attachment 1) Yes Yes Paper Only Form and instruction Certification of Status for Death Benefit - Standard Calculation (Attachment 1).docx 7 Lost Employment Income Certification - Estate (attatchment 3) Yes Yes Paper Only Form and instruction Lost Employment Income Certification - Estate (attatchment 3).docx 6 Death Benefit Certification of Relationship (Survivor Attach 3) Yes Yes Paper Only Form and instruction Death Benefit Certification of Relationship (Survivor Attach 3).docx 5 Compensation Attachment 1 Yes Yes Paper Only Form and instruction Compensation Attachment 1.pdf 4 Compensation Attachment 1 for Reps Yes Yes Paper Only Form and instruction Compensation Attachment 1 for Reps.docx 3 Compensation Attachment 1 for Estate Yes Yes Paper Only Form and instruction Compensation Attachment 1 for Estate.docx 10 Unreimbursed Medical Expenses Certification (Attach 2) Yes Yes Paper Only Form and instruction Unreimbursed Medical Expenses Certification (Attach 2).docx 9 Unreimbursed Medical Expenses Certification - Estate (Attachment 2) Yes Yes Paper Only Form and instruction Unreimbursed Medical Expenses Certification - Estate (Attachment 2).docx 8 Lost Employment Income Certification (Attach 3) Yes Yes Paper Only Form and instruction Lost Employment Income Certification (Attach 3).docx
Individuals or Households 30 4 0

2013-09-30-04:00

0915-0335 201010-0915-003 0915
             
        "Combating Autism Act Initiative Evaluation"
             
          
        
The purpose of this information collection is to determine the effectiveness of HRSA/MCHB's activities related to screening, evaluation and treatment for Autism Spectrum Disorders (ASD) and other developmental disabilities (DD), as mandated by the Combating Autism Act of 2006. 2014-02-28-05:00 Active Amanda Cash amanda.cash@hrsa.hhs.gov 301 443-0208 No No No 342 258 0

Combating Autism Act Initiative Evalutation - Training Programs - LEND No Health Health Care Services
001_LEND_CAAI 001_LEND_CAAI No No Fillable Fileable Form and instruction Attachment B LEND SSI protocol 42210.doc
Private Sector 234 176 0

Combating Autism Act Initiative Evaluation - Research Programs No Health Health Care Services
001_CAAI_Researh 001_CAAI_Researh Yes Yes Fillable Fileable Form and instruction Attachment D RN SSI protocol 42210.doc 002_CAAI_Research 002_CAAI_Research Yes Yes Fillable Fileable Form and instruction Attachment E RN Questionnaire 42210.doc 003_CAAI_Research 003_CAAI_Research Yes Yes Fillable Fileable Form and instruction Attachment F R40 AIR Program Questionnaire 42210.doc 004_CAAI_Research 004_CAAI_Research Yes Yes Fillable Fileable Form and instruction Attachment G SDAS Program Questiinnaire 42210.docx
Private Sector 54 41 0

Combating Autism Act Initiative Evaluation - Improving State Systems of Care Program No Health Health Care Services
002_CAAI_State Systems 002_CAAI_State Systems Yes Yes Fillable Fileable Form and instruction Attachment I - CAAI State Systems of Care Questionnaire.pdf 001_CAAI_State Systems 001_CAAI_State Systems Yes Yes Fillable Fileable Form and instruction Attachment H State Systems of Care SSI protocol 42210.docx
Private Sector 54 41 0

2010-12-20-05:00

0915-0336 201107-0915-002 0915
             
        "Maternal, Infant and Early Childhood Home Visiting Program- Updated State Plan"
             
          
        
The Maternal, Infant, and Early Childhood Home Visiting Program (MIECHV) is designed to: 1)strengthen programs and activities carried out under Title V; 2) improve coordination of services for at risk communities; and 3) identify and provide comprehensive services to improve outcomes for families who reside in at risk communities. The information requested in the Updated State Plan will advance the purpose of this Program. The information collection will help further the legislative purpose of the MIECHV Program. It is also intended to help States view their proposed State Home Visiting Program as a service strategy aimed at developing a comprehensive, high-quality early childhood system that promotes maternal, infant, and early childhood health, safety and development, and strong parent-child relationships in the targeted communities at risk. As a condition of receiving the remaining grant award made to States in July 2010, each of the 56 grantees is now required to develop an Updated State Plan for a State Home Visiting Program. 2014-10-31-04:00 Active Carla Haddad Carla.Haddad@hrsa.hhs.gov 301 443-0165 No Yes No 56 15176 0

Supplemental Information Request for the Submission of the Updated State Plan for A State Home Visiting Program No Health Health Care Services
1 SIR Yes Yes Fillable Fileable Form and instruction HRSA_Home_Visiting_2nd SIR FINAL 2011.docx
State, Local, and Tribal Governments 56 15176 0

2011-10-23-04:00

0915-0337 201012-0915-002 0915
             
        "NHSC Information Follow-up Form"
             
          
        
The National Health Service Corps (NHSC) is committed to improving the health of the Nation's underserved by uniting communities in need with caring health professionals and by supporting communities' efforts to build better systems of care. The NHSC Information Follow-up Form is an optional form that a health profession student, licensed clinician, faculty member, or clinical site administrator can fill out. This follow-up process is necessary to keep a potential applicant pool that is kept informed of the benefits of the NHSC and their potential membership into the Corps. 2014-03-31-04:00 Active Gerta Bardhoshi GBardhoshi@hrsa.gov 301 443-1129 No No No 2400 60 0

NHSC Information Follow-up Form No Health Health Care Services
1 Form No No Paper Only Form NHSC - Information Follow-Up Form.pdf
Individuals or Households 2400 60 0

2011-03-14-04:00

0915-0338 201012-0915-001 0915
             
        "Evaluation of Core Components of the Federal Healthy Start Program "
             
          
        
This is a one-time survey of Healthy Start Program staff. The data collection is designed to obtain information that will be used to assess program activities and services from the systems perspective. The overall purpose is to determine factors related to the successful implementation of the program, as well as the impact of Healthy Start in achieving key outcomes for participating women and children. 2014-05-31-04:00 Active Amanda Cash amanda.cash@hrsa.hhs.gov 301 443-0208 No No No 102 408 0

Healthy Start Survey No Health Health Care Services
001_Healthy Start Survey_2010 Healthy Start Survey_2010 Yes Yes Fillable Fileable Form and instruction Attachment C. HS Survey Survey Instrument_7.29.10.pdf
Private Sector 102 408 0

2011-05-16-04:00

0915-0341 201104-0915-001 0915
             
        "Retention Survey of NHSC Clinicians and Alumni/NHSC Site Administrators"
             
          
        
The National Health Service Corps (NHSC) Loan Repayment and Scholarship Programs were established to assure an adequate supply of trained primary care health care professionals to provide services in the neediest Health Professional Shortage Areas (HPSAs) of the United States. The last survey conducted to analyze retention of NHSC clinicians was over a decade ago. This new survey will reevaluate the personal/professional development of NHSC clinicians in an effort to retain the clinicians in service providing care for individuals residing in underserved areas. 2014-07-31-04:00 Active Gerta Bardhoshi GBardhoshi@hrsa.gov 301 443-1129 No No No 7464 1162 0

Survey of Site Administrator No Health Health Care Services
1 Survey of 2010 Site Administrators Yes Yes Fillable Printable Form CurrentSiteAdministrator-Revised 6-30-11.pdf
Private Sector 500 63 0

Survey of NHSC Clinicians in Service (LRP) No Health Health Care Services
2 Survey of NHSC Clinicians in Service (LPR) Yes Yes Fillable Printable Form CurrentClinicians-LRP-Revised 6-30-11.pdf
Individuals or Households 2740 301 0

Survey of NHSC Clinicians in Service (Scholars) No Health Health Care Services
3 Survey of NHSC Clinicians in Service (Scholars) Yes Yes Fillable Printable Form CurrentClinicians-Scholarship-Revised 6-30-11.pdf
Individuals or Households 536 75 0

Survey of NHSC Alumni (LRP) No Health Health Care Services
4 Survey of NHSC Alumni (LRP) Yes Yes Fillable Printable Form RemoteAlumniClinician-Revised 6-30-11.pdf
Individuals or Households 2393 550 0

Survey of NHSC Recent Alumni (LRP) No Health Health Care Services
5 Survey of NHSC Recent Alumni (LRP) Yes Yes Fillable Printable Form RecentAlumni-LRP-Revised 6-30-11.pdf
Individuals or Households 435 44 0

Survey of NHSC Recent Alumni (Scholars) No Health Health Care Services
6 Survey of NHSC Recent Alumni (Scholars) Yes Yes Fillable Printable Form RecentAlumni-Scholars-Revised 6-30-11.pdf
Individuals or Households 860 129 0

2011-07-26-04:00

0915-0342 201106-0915-001 0915
             
        "Reconciliation Tool for the Teaching Health Centers Graduate Medical Education Program"
             
          
        
Teaching Health Centers Graduate Medical Education (THCGME) is an initiative to promote primary care residency training in community-based settings. The THCGME model is one of many different training models supported by the Affordable Care Act to address the shortage in primary care health providers. The statute allows THCs to receive payments for both direct and indirect costs associated with training residents in community-based ambulatory patient care centers. The Reconciliation Tool will be used to collect information relating to the number of Full-Time Equivalents (FTE) supported with THCGME payments in order to reconcile costs for both direct and indirect costs. 2014-08-31-04:00 Active Carla Haddad Carla.Haddad@hrsa.hhs.gov 301 443-0165 No Yes No 51 255 0

THCGME Reconciliation Tool No Health Health Care Services
1 Reconciliation Tool Yes Yes Fillable Fileable Form Reconciliation_Tool 052611.docx
Private Sector 51 255 0

2011-08-10-04:00

0915-0343 201107-0915-001 0915
             
        "Poison Help General Population Survey"
             
          
        
The Poison Help campaign is the vehicle for introducing the national toll-free number for use in poisoning emergencies and providing poison prevention information to all age groups and audience segments. The overarching goals for the campaign are to raise awareness of the national toll-free number to levels on a par with 911 and 411 and to increase awareness of the availability of poison center services. Campaign messages and activities promote awareness of the national toll-free number, the role poison centers play and the services they provide in disseminating poison information and treatment advice in poisoning emergencies. The goal of HRSA's Poison Help General Population Telephone Survey is to evaluate the campaign's current performance. Assessment information will include awareness and use of the national toll-free number to access poison exposure or information services and awareness and knowledge of poison centers and the services they provide. The survey will allow for some comparisons with previous data, as well as comparisons with follow-up evaluation activities to be conducted in future years, and provide direction for future campaign initiatives. 2014-10-31-04:00 Active Carla Haddad Carla.Haddad@hrsa.hhs.gov 301 443-0165 No No No 2353 370 0

Poison Help General Population Survey No Health Health Care Services
2 Poison Help Survey Final No Printable Only Form Poison Help Survey_Final_10.17.11.docx 1 Poison Help Survey Screener No Printable Only Form Poison Help Survey Screener_10.17.11.docx
Individuals or Households 2353 370 0

2011-10-31-04:00

0915-0344 201204-0915-001 0915
             
        "Sickle Cell Disease Program Evaluations"
             
          
        
This statement is a request for Office of Management and Budget approval for evaluation and quality improvement activities of the Sickle Cell Disease and Newborn Screening Program (SCDNBSP) and the Sickle Cell Disease Treatment and Demonstration Program (SCDTDP). The purpose of the evaluations and quality improvement activities is to assess the service delivery processes and outcomes resulting from the systems of care delivered by SCDNBSP and SCDTDP networks to individuals affected by Sickle Cell Disease (SCD) who present at their sites for care. 2014-12-31-05:00 Active Jodi Duckhorn 301 443-1984 No No No 7638 2787 0

Sickle Cell Disease and Newborn Screening Program (SCDNBSP) Evaluation - MDP SCD Questioniare No Health Health Care Services
1 SCD Questionnaire Form Yes Yes Fillable Fileable Form and instruction Clean Minimum Database Project SCD Questionnaire Form_4_5_12.docx Yes No Printable Only Instruction ATTACH_D_NCEC_SCDNBSP_Instruments_11_14_11 revision.docx
Private Sector 280 126 0

Sickle Cell Disease and Newborn Screening Program (SCDNBSP) Evaluation - MDP SCT Questioniare No Health Health Care Services
Yes No Printable Only Instruction ATTACH_D_NCEC_SCDNBSP_Instruments_11_14_11 revision.docx 2 SCT Questionnaire Form Yes Yes Fillable Fileable Form and instruction Clean Minimum Database Project SCT Questionnaire Form _4_5_12.docx
Private Sector 1400 420 0

Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Utilization Questionnaire (pre-demonstration) No Health Health Care Services
3 Utilization Data Form Yes No Printable Only Form and instruction Clean Individual Utilization Data Form_4_5_12(2).doc
Individuals or Households 900 675 0

Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Utilization Post No Health Health Care Services
EDITED 8-29-11 Attach_E_Individual Utilization Data Form_Mar2010 - EDITED 8-29-111 Yes No Printable Only Form and instruction Individual Utilization Data Form_Mar2010 - EDITED 8-29-111.pdf
Individuals or Households 900 450 0

Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Health Survey No Health Health Care Services
5 Short Form 8 Health Survey (adult) Yes Yes Fillable Fileable Form Indicator Crosswalk for SF36-SF8 and PedsQL-PedsQL SF 15.xls
Individuals or Households 1260 126 0

Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - PedsQL for Parents No Health Health Care Services
Yes No Printable Only Instruction ATTACH_P_scoring_PedsQL_v6.pdf PedsQL Pediatric Quality of Life Inventory for parents of children and adolescents age 18 or younger Yes Yes Fillable Fileable Form and instruction PedsQL Version 4.0 ShortForm (SF15).pdf
Individuals or Households 540 108 0

Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - PedsQL for children & adolescents No Health Health Care Services
PedsQL Pediatric Quality of Life Inventory for children and adolescents age 18 or younger Yes Yes Fillable Fileable Form and instruction PedsQL Version 4.0 ShortForm (SF15).pdf Yes No Printable Only Instruction ATTACH_P_scoring_PedsQL_v6.pdf
Individuals or Households 450 90 0

Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Medical Home Family Index No Health Health Care Services
007_Sickle Cell_Medical Home Index_Short 007_Sickle Cell_Medical Home Index_Short Yes Yes Fillable Fileable Form ATTACH_G_CMHI-MHI-Pediatric_Short-Version.pdf 007_Sickle Cell_Medical Home Index_Full 007_Sickle Cell_Medical Home Index_Full Yes Yes Fillable Fileable Form ATTACH_F_CMHI-MHI-Pediatric_Full-Version.pdf
Individuals or Households 0 0 0

Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Quality Improvement Instrument No Health Health Care Services
008_Sickle Cell_QI Instrument 008_Sickle Cell_QI Instrument Yes Yes Fillable Fileable Form SCDTDP Quality Improvement Instrument.docx
Private Sector 108 432 0

Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Client Family Communication Form No Health Health Care Services
009_Sickle Cell_Client and Fam Comm Form 009_Sickle Cell_Client and Fam Comm Form No No Fillable Fileable Form ATTACH_R_Family Communication for SCDTDP.docx
Individuals or Households 1800 360 0

2012-05-04-04:00

0915-0345 201110-0915-004 0915
             
        "AIDS Drug Assistance Program (ADAP) Data Report "
             
          
        
The HIV/AIDS Bureau within HRSA of the United States Department of Health and Human Services (DHHS) administers funds for the Ryan White HIV/AIDS Program. The ADAP Data Report (ADR) is designed to replace the historic ADAP Quarterly Report (AQR). The ADR will be used to collect information from grantees funded under Part B of the Ryan White HIV/AIDS Treatment Extension Act of 2009 (Ryan White HIV/AIDS Program, as codified under title XXVI of the Public Health Service Act. The program is authorized by the Ryan White HIV/AIDS Treatment Extension Act of 2009 (Public Law 111-87) through 2013. 2014-12-31-05:00 Active Gerta Bardhoshi GBardhoshi@hrsa.gov 301 443-1129 No No No 285 52405 0

ADAP Grantee Report No Health Health Care Services
1 ADAP Grantee Report Yes Yes Fillable Fileable Form C - ADR Grantee Report.doc
Private Sector 114 1425 0

ADAP Client Report No Health Health Care Services
2 ADAP Client Report Yes Yes Fillable Fileable Form D - ADR Client-Level Data Elements.doc
Individuals or Households 114 3898 0

Data Collection System No Health Health Care Services Private Sector 57 47082 0

2011-12-30-05:00

0915-0346 201206-0915-006 0915
             
        "Patient Navigator Outreach and Chronic Disease Prevention Demonstration Program "
             
          
        
Ten grants have been awarded to eligible entities for the development and operation of demonstration programs to provide patient navigator services to improve health care outcomes. The Patient Navigator Outreach and Chronic Disease Prevention Demonstration Program assesses whether local initiatives can reduce the burden of cancer and other chronic diseases such as obesity, diabetes, asthma and others by reducing the barriers related to accessing high quality health care services. This evaluation consists of two parts of data collection: 1) collection of qualitative information from staff associated with the Patient Navigation Demonstration Program; and 2) quantitative data related to the demographics and care of all patientss entering PNDP, as well as patient navigators. 2015-08-31-04:00 Active Jodi Duckhorn 301 443-1984 No Yes No 49393 12048 0

Navigated Patient Data Intake Form No Health Health Care Services
1 IntakeAndTarget_20111014 Yes Yes Fillable Fileable Form and instruction IntakeAndTarget_20111014.pdf
Individuals or Households 4827 2414 0

VR-12 Health Status Form No Health Health Care Services
2 VR_12_English_Self20110919v4 Yes Yes Fillable Fileable Form and instruction VR_12_English_Self20110919v4.pdf
Individuals or Households 9654 1158 0

Patient Navigator Survey No Health Health Care Services
3 Patient_Navigator_Form Yes Yes Fillable Fileable Form and instruction HRSA_Patient_Navigator_Demonstration_Program_Navigator_Form.doc
Individuals or Households 46 9 0

Patient Navigator Encounter/Target Services Log No Health Health Care Services
4 Forms_20110919.v1 Yes Yes Fillable Fileable Form and instruction Forms_20110919.v1.pdf 5 Target Services Log Yes No Fillable Fileable Form and instruction HRSA_Patient_Navigator_Demonstration_Program_Target_Form.doc
Individuals or Households 28962 7241 0

Patient Navigator Focus Group No Health Health Care Services
6 PN_Focus Group Yes No Printable Only Form and instruction Patient_Navigator_Focus_group.docx 14 Consent Form Yes No Printable Only Form and instruction Consent_for_PNDP_Discussion_Questions_3-7-11_doc.doc 15 Participant Information Form Yes No Printable Only Form and instruction PARTICIPANT_INFORMATION_FORM.doc
Individuals or Households 46 46 0

Patient Medical Record and Clini Data No Health Health Care Services
7 Co-Occuring Disorders Yes Yes Fillable Fileable Form and instruction HRSA_Patient_Navigator_Demonstration_Program_Co_occurring_Disorders.doc 8 Clinical Measures Yes Yes Fillable Printable Form and instruction HRSA_Patient_Navigator_Demonstration_Program_Clinical_Measures_Lab_Tests.doc
Private Sector 4827 821 0

Annual Clinic-Wide Clinical Performance Mearsures Report No Health Health Care Services
9 Clinic-Wide Measures Yes Yes Fillable Fileable Form HRSA_Patient_Navigator_Demonstration_Program_Clinicwide_Measures_Form.doc
Private Sector 5 40 0

Patient Navigator ultural Competency Checklist No Health Health Care Services
10 Cultural Competency Yes Yes Fillable Fileable Form and instruction HRSA_Patient_Navigator_Demonstration_Program_Cultural_Competency_Checklist.doc
Private Sector 46 54 0

Patient Navigator/Health System Administrator Focus Group No Health Health Care Services
14 Consent Form Yes No Printable Only Form and instruction Consent_for_PNDP_Discussion_Questions_3-7-11_doc.doc 11 Health_Administrator_Focus_Gorup Yes No Printable Only Form and instruction PNDP2_FocusGroup_Administrators.doc 15 Participant Information Form Yes No Printable Only Form and instruction PARTICIPANT_INFORMATION_FORM.doc
Private Sector 50 50 0

Grantee Health Care Provider Focus Group No Health Health Care Services
14 Consent Form Yes No Printable Only Form and instruction Consent_for_PNDP_Discussion_Questions_3-7-11_doc.doc 15 Participant Information Form Yes No Printable Only Form and instruction PARTICIPANT_INFORMATION_FORM.doc 12 Focus_Group_Health_Provider Yes No Printable Only Form and instruction PNDP2_FocusGroup_HealthCareProv.doc
Private Sector 30 30 0

Social Service Provider Focus Group No Health Health Care Services
15 Participant Information Form Yes No Printable Only Form and instruction PARTICIPANT_INFORMATION_FORM.doc 14 Consent Form Yes No Printable Only Form and instruction Consent_for_PNDP_Discussion_Questions_3-7-11_doc.doc 13 Focus_Group_Social_Service Yes No Printable Only Form and instruction PNDP2_FocusGroup_06142011Social.doc
Private Sector 50 50 0

Quarterly Report No Health Public Health Monitoring
14 Quarterly Report Yes Yes Fillable Fileable Form and instruction HRSA_Patient_Navigator_Demonstration_Program_Quarterly_Report_Form.doc
Private Sector 40 40 0

Client Opinion Form No Health Health Care Services
13 Clinet Opinion Form Yes Yes Fillable Fileable Form and instruction ClientOpinionForm_2012_08_28 - REVISED.doc 13a Clinet Opinon Form Spanish Yes Yes Fillable Fileable Form and instruction ClientOpinionForm_SPANISH_2012_08_28 - REVISED.doc
State, Local, and Tribal Governments 810 95 0

2012-08-31-04:00

0915-0347 201208-0915-006 0915
             
        "Evaluation of the Text4baby Program "
             
          
        
Text4baby is a mobile health education program that provides free, brief, evidence-based, health messages to women who are pregnant or have an infant under one year of age. The goal of this program evaluation is to examine the characteristics of women who utilize the Text4baby mobile phone-based program, to assess their experience with the program, and to determine whether enrollment in Text4baby is associated with healthy behaviors and timely access to health care during pregnancy and an infant's first year of life. 2015-02-28-05:00 Active Carla Haddad Carla.Haddad@hrsa.hhs.gov 301 443-0165 No No No 5266 1196 0

Safety Net Consumer Survey Round 1 No Health Health Care Services
1 Safety Net Consumer Survey R1 Yes Yes Fillable Fileable Form Round1 HPP Survey 08_16_2012.docx
Individuals or Households 960 317 0

Safety Net Consumer Survey Round 2 No Health Health Care Services
2 R2 HPP Survey Revised Jan 2012 Access Questions Yes Yes Fillable Fileable Form R2 HPP Survey Revised Jan 2012 Access Questions.docx
Individuals or Households 768 253 0

Consumer Focus Groups No Health Health Care Services
Focus Group-1 Focus Group Discussion Protocol No No Paper Only Form Attachment D1 Consumer Focus Group Protocol May 2012.docx Focus Group-3 Focus Group: Participant Information Form (Postpartum Women) No No Paper Only Form Part A Attachment D3 Participant Information Form Postpartum Women - FINAL.docx Focus Group-2 Focus Group: Participant Information Form (Pregnant Women) No No Paper Only Form Part A Attachment D2 Participant Information Form Pregnant Women-FINAL.docx
Individuals or Households 80 120 0

Key Informant Interviews No Health Health Care Services
1 Key Informant Interview Discussion Guide No No Paper Only Form Attachment E Key Informant Interview Discussion Guide May 2012.docx
Private Sector 40 30 0

Stakeholder Interviews No Health Health Care Services
Stakeholder 1 Stakeholder Interview Guide No No Paper Only Form Part A Attachment F Stakeholder Discussion Guide.docx
Private Sector 30 23 0

Consent Training and Coordination No Health Health Care Services Private Sector 128 128 0

Prenatal Patient and Parent of Minor Consent No Health Health Care Services Private Sector 3260 325 0

2012-08-22-04:00

0915-0348 201112-0915-002 0915
             
        "National Sample Survey of Nurse Practitioners"
             
          
        
The primary purpose of the Bureau of Health Profession's National Sample Survey of Nurse Practitioners (NPs) data collection is to: (1) Improve estimates of NPs providing services; (2) describe the settings where NPs are working; (3)identify the positions/roles in which NPs are working; (4) describe the activities and services NPs are providing in the healthcare workforce; (5) determine the specialties in which NPs are working; (6) explore NPs'satisfaction with and perception of the extent to which they are working to their full scope of practice; and (7) assess variations in practice settings, positions, and practice patterns by demographic and educational characteristics. 2015-02-28-05:00 Active Carla Haddad Carla.Haddad@hrsa.hhs.gov 301 443-0165 No No No 14300 4719 0

National Sample Survey of Nurse Practitioners No Health Public Health Monitoring
1 NSSNP Questionnaire No Paper Only Form OMB NSSNP Questionnaire_FINAL_2.17.12.docx
Individuals or Households 14300 4719 0

2012-02-28-05:00

0915-0349 201112-0915-006 0915
             
        "HIV Clinician Workforce Study "
             
          
        
The HIV/AIDS Bureau (HAB) within HRSA in the Department of Health and Human Services (HHS) is embarking on a 24-month quantitative HIV clinician workforce study to provide HRSA and other federal and state agencies with national and regional estimates of the number of primary care clinicians providing medical care to people living with HIV or AIDS in the United States, as well as projections of the magnitude of the shortage or surplus of HIV-related primary care clinicians through 2015. The study focuses on the supply and demand of health professionals who treat and manage care for patients living with HIV and AIDS. The primary purpose of the survey is to collect comprehensive information necessary for developing HIV-specific input parameters for the workforce forecasting model. 2015-06-30-04:00 Active Gerta Bardhoshi GBardhoshi@hrsa.gov 301 443-1129 No No No 3850 1330 106063

HIV Clinician Survey No Health Health Care Services
Yes No Printable Only Instruction Info_Brochure_Clinician_Survey.pdf 2 Pretest Yes Yes Fillable Fileable Form and instruction Pretest-Version-Questionnaire_Clinician-Survey.pdf Yes No Printable Only Other Study_Design_Report.pdf 1 Clinician survey Yes Yes Fillable Fileable Form and instruction HIV Clinician Workforce Study - Final Design Report (To HRSA).docx Yes No Printable Only Other Web_Example.pdf
Individuals or Households 3500 1155 96546

HIV Practice Survey No Health Public Health Monitoring
2 Pre_and_post_test Yes Yes Fillable Fileable Form and instruction Post-Pretest-Version-Questionnaire_Practice-Survey.pdf Yes No Printable Only Instruction Info_Brochure_Practice_Survey.pdf 1 HIV_Practice_Survey Yes Yes Fillable Fileable Form and instruction HIV_Practice_Survey.pdf Yes No Printable Only Other Study_Design_Report.pdf
Individuals or Households 350 175 9517

2012-06-01-04:00

0915-0350 201203-0915-002 0915
             
        "Cultural and Linguistic Competency and Health Literacy Data Collection Checklist"
             
          
        
The purpose of the Cultural and Linguistic Competency and Health Literacy Data Collection Checklist is to increase the number of HRSA-funded programs that have integrated cultural and linguistic competence and health literacy into their policies, guidelines, contracts and training. This checklist is needed to assure that HRSA grantees, serving a highly diverse patient and student population deliver prevention, treatment and educational services that yield the highest attainable outcomes for these populations in keeping with the Department of Health and Human Services National Standards for Culturally and Linguistically Appropriate Services. 2015-06-30-04:00 Active Carla Haddad Carla.Haddad@hrsa.hhs.gov 301 443-0165 No Yes No 900 900 0

Data Collection Checklist No Health Health Care Services
1 Checklist Yes Yes Fillable Fileable Form and instruction GPOM 2011-01 Culture and Health Literacy Checklist.pdf
Private Sector 900 900 0

2012-06-08-04:00

0915-0351 201206-0915-001 0915
             
        "Maternal, Infant, and Early Childhood Home Visiting Program FY 2012 Competitive Funding Opportunity Announcement"
             
          
        
The goal of the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) competitive grant program is to award additional funding to states that have sufficiently demonstrated the interest and capacity to expand and/or enhance their evidence-based home visiting programs to improve outcomes for children and families who reside in high-risk communities. Successful applicants will be awarded competitive grant funds, in addition to the MIECHV formula based funds, to support the effective implementation of home visiting programs that are part of comprehensive, high-quality early childhood systems in all states. Applicants will be evaluated by their demonstrated commitment to implementing high-quality home visitation programs and the quality of plans to expand services and improve outcomes for vulnerable children and families. 2015-07-31-04:00 Active Jodi Duckhorn 301 443-1984 No Yes No 20 900 0

Application and Submission Information for FY 2012 Competitive FOA No Health Illness Prevention
1 Application and Submission Information Yes Yes Printable Only Form and instruction Instrument.docx
State, Local, and Tribal Governments 20 900 0

2012-07-06-04:00

0915-0352 201203-0915-001 0915
             
        "Area Health Education Centers Project on the Mental and Behavioral Health and Substance Abuse Issues of Veterans/Service Members and Their Families"
             
          
        
This project will evaluate whether or not providers change their practice after receiving continuing education. Trained AHEC staff will provide continuing education (CE) for civilian primary care, mental and behavioral health, and other healthcare providers to improve the quality and cultural competency of the care they offer to veterans/service members and their families and will conduct an evaluation of those offerings. Two instruments will be used in the evaluation, including the CE evaluation results form and the CE evaluation follow-up form. These instruments will provide aggregate information about the providers trained and project activities and will assess through a follow-up survey whether a provider changed their practice after receiving the CE offering. 2015-07-31-04:00 Active Carla Haddad Carla.Haddad@hrsa.hhs.gov 301 443-0165 No Yes No 12000 5340 0

CE Evaluation Resuts Form No Health Consumer Health and Safety
1 CE Evaluation Results Form No No Paper Only Form and instruction 1 CE Evaluation Results Form No Paper Only Form and instruction REVISED CE Evaluation Results Form.docx
Private Sector 10000 5000 0

CE Evaluation Follow-up Form No Health Consumer Health and Safety
2 CE Evaluation Follow-up Form No Paper Only Form and instruction REVISED CE Evaluation Follow-up Form.docx
Private Sector 2000 340 0

2012-07-16-04:00

0915-0353 201309-0915-003 0915
             
        "Work Force Recruitment in BPHC-Funded Health Centers "
             
          
        
This survey is designed to collect information from HRSA-funded health centers regarding their current workforce. This baseline data is essential in demonstrating the effectiveness of recruitment efforts over the next year for returning veterans, many of whom have trained as health care providers and/or administrators during their time in the service. The survey will help assess how health centers have filled recent vacancies, whether the availability of veterans to join the health center workforce is impacting their hiring efforts, and what additional efforts might improve health center recruitment at a critical time of expansion in the nation's health care safety net. 2016-02-29-05:00 Active Jodi Duckhorn 301 443-1984 No No No 2400 2400 0

Work Force Recruitment in BPHC-Funded Health Centers Survey No Health Public Health Monitoring
1 workforce survey Yes Yes Fillable Fileable Form and instruction BPHC 2013 Workforce Recruitment Survey clean.pdf
Private Sector 2400 2400 0

2013-09-23-04:00

0915-0354 201305-0915-005 0915
             
        "Rural Health Community-Based Grant Programs Data Collection Tool"
             
          
        
HRSA's Office of Rural Health Policy is requesting OMB approval of a new activity to collection information on grantee activities and performance measures electronically through the Performance Improvement and Measurement System (PIMS). This activity will collect information for the Rural Health Information Technology Network Development Program (RHITND) to provide HRSA with information on grant activities funded under this program, as well as information to meet requirements under the Government Performance and Results Act of 1993 (GPRA). 2016-07-31-04:00 Active Jodi Duckhorn 301 443-1984 No No No 41 233 0

Rural Health Information Technology Network Development No Health Public Health Monitoring
1 RHITND PIMS Yes Yes Fillable Fileable Form and instruction RHITND PIMS-final.docx
Private Sector 41 233 0

2013-07-18-04:00

0915-0355 201208-0915-003 0915
             
        "Maternal, Infant, and Early Childhood Home Visiting Program FY 2012 Competitive Noncompeting Continuation Progress Reports (X02)"
             
          
        
This information collection is needed for eligible entities to receive subsequent funds under the MIECHV program. As noted above, this program is authorized under the Social Security Act, Title V, Section 511 (42 U.S.C. ?701), as amended by Section 2951 of the Patient Protection and Affordable Care Act of 2010 (Public Law 111-148). A portion of funding under this program is awarded to participating states and eligible jurisdictions by formula. However, an additional portion of funds was awarded competitively. The information collected will be used to review grantee progress on proposed project plans sufficient to permit project officers to assess whether the project is performing adequately to achieve the goals and objectives that were previously approved. This report will also provide implementation plans for the upcoming year, which project officers can assess to determine whether the plan is consistent with the grant as approved, and will result in implementation of a high quality project that will complement the state home visiting program as a whole. NCC Progress Reports are entered into HRSA's Electronic Handbook (EHB). 2015-09-30-04:00 Active Jodi Duckhorn 301 443-1984 No Yes No 56 2352 0

progress report on FY11 activities final 4.5.12 No Health Public Health Monitoring
1 Formula X02 Progress Report Instructions Yes Yes Fillable Fileable Form and instruction Formula X02 Progress Report Instructions_rea.docx
State, Local, and Tribal Governments 56 2352 0

2012-09-25-04:00

0915-0356 201306-0915-001 0915
             
        "Maternal, Infant, and Early Childhood Home Visiting Program FY 2012 Competitive Noncompeting Continuation Progress Reports (D89)"
             
          
        
This information collection is needed for eligible entities to receive subsequent funds under the MIECHV program. As noted above, this program is authorized under the Social Security Act, Title V, Section 511 (42 U.S.C. ?701), as amended by Section 2951 of the Patient Protection and Affordable Care Act of 2010 (Public Law 111-148). A portion of funding under this program is awarded to participating states and eligible jurisdictions by formula. However, an additional portion of funds was awarded competitively. The information collected will be used to review grantee progress on proposed project plans sufficient to permit project officers to assess whether the project is performing adequately to achieve the goals and objectives that were previously approved. This report will also provide implementation plans for the upcoming year, which project officers can assess to determine whether the plan is consistent with the grant as approved, and will result in implementation of a high quality project that will complement the state home visiting program as a whole. NCC Progress Reports are entered into HRSA's Electronic Handbook (EHB). 2015-09-30-04:00 Active Jodi Duckhorn 301 443-1984 No Yes No 33 1452 0

Progress Report Guidance No Health Health Care Services
1 Competitive NCC Progress Report Yes Yes Fillable Fileable Form and instruction Competitive D89 FY 13 NCC Progress Report Instructions_OMB Exp 9 30 2015_DGIS Review_rev 5.28.13.docx
State, Local, and Tribal Governments 33 1452 0

2013-06-14-04:00

0915-0357 201208-0915-005 0915
             
        "Data Collection Forms for the Maternal, Infant and Early Childhood Home Visiting Program Information System"
             
          
        
The Social Security Act, Title V, Section 511 (42 U.S.C. 701), as amended by the Patient Protection and Affordable Care Act of 2010, requires that MIECHV grantees collect data to measure improvements for eligible families in six specified areas (referred to as "benchmark areas") that encompass the major goals for the program. These include: 1. Improved maternal and newborn health 2. Prevention of child injuries, child abuse, neglect, or maltreatment, and reduction in emergency department visits 3. Improvement in school readiness and achievement 4. Reduction in crime or domestic violence 5. Improvement in family economic self-sufficiency 6. Improvement in the coordination and referrals for other community resources and supports 2015-10-31-04:00 Active Jodi Duckhorn 301 443-1984 No Yes No 81 76739 0

Home Visiting Program Information System No Health Public Health Monitoring
1 HV Form 1 Yes Yes Fillable Fileable Form and instruction C - HV Form 1 - Demographic and Service Utilization Data draft w public burden statement 8 1 2012.docx 2 HV form 2 Yes Yes Fillable Fileable Form and instruction D - HV Form 2 - Grantee-defined performance measures w public burden statement 8-1-12.docx
State, Local, and Tribal Governments 81 76739 0

2012-10-12-04:00

0915-0358 201210-0915-001 0915
             
        "Healthy Weight Collaborative"
             
          
        
As part of Collaborate for Healthy Weight, in collaboration with HRSA and a coalition of partner organizations, NICHQ has created the Healthy Weight Collaborative (HWC) to identify model approaches linking clinical services, public health functions, and other community services to address childhood and family obesity. The HWC aims to prevent and treat childhood obesity by working with 50 community teams to identify, test, and evaluate a national HWC change package of evidence-based program and policy interventions. HRSA is seeking OMB clearance to gather information from the HWC community teams and NICHQ leaders, staff, and faculty in order to conduct an implementation study of Phase 2 of program implementation of the HWC project. The goal of the implementation study is to document the ongoing development and refinement of the HWC project's "change package," in Phase 2 of program implementation of the project, as well as the adaptation of the project's learning collaborative process in a virtual format with no in-person meetings. The study will also document the participation of the 40 Phase 2 community teams, their experiences, and their results. 2016-03-31-04:00 Active Jodi Duckhorn 301 443-1984 No Yes No 103 136 0

Healthy Weight Collaborative No Health Immunization Management
Yes Yes Paper Only Other Informed Consent Form - Final 11-28-12.docx 4 observation template Yes Yes Paper Only Form learning session observation template.docx 3 NICHQ Yes Yes Paper Only Form Phase 2 NICHQ Leadership.docx 1 Phase 1 interviews No No Paper Only Form Phase 1 community team interviews.docx 2 Phase 2 Yes Yes Paper Only Form Phase 2 Community Team Interviews.docx
Private Sector 103 136 0

2013-03-20-04:00

0915-0359 201211-0915-001 0915
             
        "Sickle Cell Disease Treatment Demonstration Program QI Measures"
             
          
        
The purpose of the quality improvement data collection strategy is to measure progress in meeting the goals of the Sickle Cell Disease Treatment and Demonstration Program (SCDTDP) and to implement a system to monitor the progress of HRSA's Maternal and Child Health Bureau (MCHB) funded activities in improving care and health outcomes for individuals living with sickle cell disease and sickle cell trait. 2016-03-31-04:00 Active Jodi Duckhorn 301 443-1984 No No No 324 2700 0

Sickle Cell Disease Treatment Demonstration Program - Quality Improvement Data Collection for the Hemoglobinopathy Learning Collaborative No Health Health Care Services
1 Participant Profile Yes Yes Fillable Fileable Signable Form Appendix C Participant Profile.pdf 2 Acute Care Visit Yes Yes Fillable Fileable Signable Form Appendix D Acute Care Visit.pdf 3 Ambulatory Care Visit Yes Yes Fillable Fileable Signable Form Appendix E Ambulatory Care Visit.pdf
Private Sector 324 2700 0

2013-03-20-04:00

0915-0360 201305-0915-006 0915
             
        "Health Center Controlled Networks Progress Reports"
             
          
        
A priority for HRSA's Bureau of Primary Health Care is to provide grants to Health Ccenter Controlled Networks (HCCN) to support and advance the adoption, implementation, and meaningful use of Health Information Technology to improve the quality of care provided by existing Health Center Program grantees. HCCNs will support participating health centers through their participation in the current and future stages of meaningful use included in the Medicare and Medicaid EHR Incentive Programs. The CMS EHR Incentive Program provides incentive payments to the eligible health care providers as they adopt, implement, upgrade and demonstrate meaningful use of certified EHR technology. Stage 1 sets the baseline for electronic data capture and information sharing. Also, Stage 1 meaningful use criteria focus heavily on establishing the functionalities in certified EHR technology that will allow for continuous quality improvement and ease of information exchange. There are two progress report forms and both are designed to collect aggregate performance data from grantees funded. The Project Work Plan Update and Annual Progress/Interim Evaluation Progress Report forms have three parts: 1) Adoption and Implementation of HIT (including EHR); 2) Attainment of Meaningful Use Requirements; and 3) Quality improvement measures (e.g., Healthy People 2020 clinical quality measures, PCMH recognition status). 2016-03-31-04:00 Active Jodi Duckhorn 301 443-1984 No No No 60 1662 0

Health Center Controlled Networks Progress Reports No Health Health Care Services
2 Repport Table Instructions Yes Yes Fillable Fileable Form and instruction Report_Table_Instructions.docx 1 work plan Yes Yes Fillable Fileable Form and instruction APPENDIX B Instructions for Work Plan_EL 04302013v1.docx
Private Sector 60 1662 0

2013-05-31-04:00

0915-0361 201301-0915-003 0915
             
        "Telehealth Resource Center Grant Program Performance"
             
          
        
The primary objective of the Telehealth Resource Center Grant Program (TRC Grant Program) is to provide technical assistance and share expertise with health care organizations, health care providers and health care networks interested in implementing telehealth technology. The resource centers serve as focal points for advancing the effective use of telehealth technologies in their respective communities and regions. In 2010, HRSA awarded grant funds to support eight ("Regional" TRCs). The TRC grant program is authorized under ?330I(d)(2) of the Public Health Service Act (42 U.S.C. 254c-14(d)(2), as amended by the Health Care Safety Net Amendments of 2002 (P.L. 107-251). 2016-03-31-04:00 Active Jodi Duckhorn 301 443-1984 No No No 760 53 0

TRC Performance Indicator Data Collection Tool No Health Health Care Services
1 TRC Performance Indicatator Data Collection Tool Yes Yes Fillable Fileable Form and instruction TRC Performance Indicatator Data Collection Tool.docx
Private Sector 760 53 0

2013-03-20-04:00

0915-0362 201304-0915-003 0915
             
        "Corps Community Day Event Form"
             
          
        
The goals of Corps Community Day encompass the following: increase awareness of the NHSC to potential applicants and the greater primary health community; create a sense of community and connectedness among NHSC program participants, alumni, partners and staff; and underscore the NHSC's role in bringing primary health care services to the nation's neediest communities. Current program participants, alumni, NHSC Ambassadors, sites, primary care organizations, and professional associations plan events and report the details of their events to BCRS so that they can be added to the state-by-state map of events. In order to avoid duplication of effort, eliminate confusion regarding allowable event dates, avoid data entry errors, and implement a brief post-event satisfaction survey, BCRS would like to implement a standard form that event planners will use to report to BCRS. The fillable form will be available online and will have less than 20 fields for event planners to populate to submit for inclusion on the map. There will also be approximately 5 fields to populate following the event to measure satisfaction. Both the pre-event and post-event data fields will be held in one form. 2016-05-31-04:00 Active Jodi Duckhorn 301 443-1984 No Yes No 600 30 0

Corps Community Day Event Forms No Health Health Care Services
1 Corps Community Day Event Form Yes Yes Fillable Fileable Form instrument.docx
State, Local, and Tribal Governments 600 30 0

2013-05-30-04:00

0915-0363 201305-0915-001 0915
             
        "Medicare Rural Hospital Flexibility Grant Program Performance Measures"
             
          
        
The purpose of the performance measures is to provide standardized useful information about funded activities, to monitor grantee progress and to demonstrate program impact. The information will be gather from the 45 Medicare Rural Hospital Flexibility Grant Program recipients and will be used to inform program and the grantees of the effectiveness of the program activities. 2016-07-31-04:00 Active Jodi Duckhorn 301 443-1984 No No No 45 9720 0

Medicare Rural Hospital Flexibility Grant Program Performance Measures No Health Public Health Monitoring
1 Medicare Rural Hospital Flexibility Grant Program Performance Measures Yes Yes Fillable Fileable Form Flexmeasures attachment C.docx
State, Local, and Tribal Governments 45 9720 0

2013-07-02-04:00

0915-0364 201305-0915-004 0915
             
        "Organ and Tissue Donor and Recipient Life Stories Form"
             
          
        
The Division of Transplantation proposes to develop an application to give organ recipients, living donors, and donor families the opportunity to voluntarily submit their stories to DoT via a standardized online form. The online form will be posted on organdonor.gov and will collect demographic and contact information, the individual's donation/transplant story up to 500 words, a high resolution photo and a signed authorization. The standardized, electronic form will increase HRSA staff's ability to process those stories more efficiently. In addition to enabling story submission, the online application process will make the donor and recipient life stories posted on the site searchable by the public to enhance public viewing and understanding of the organ donation process. Submission of a story and completion of the form is voluntary. Overall, this application has the potential to strengthen DoT's outreach efforts and increase organ donation registration in the United States. 2016-07-31-04:00 Active Jodi Duckhorn 301 443-1984 No No No 100 68 0

Donor Life Stories Form No Health Illness Prevention
1 Donor Recipient Life Stories Form No Yes Fillable Fileable Form and instruction Life Stories Submission form 4.8 no TC.docx
Individuals or Households 100 68 0

2013-07-18-04:00

0915-0365 201307-0915-002 0915
             
        "Experiences with 1115 Medicaid Waivers relative to the Ryan White HIV/AIDS Program and Its Clients and Providers"
             
          
        
Section 1115 of the Social Security Act allows states to develop new approaches to providing Medicaid coverage. This project will examine 1115 waivers that expand Medicaid eligibility to include people living with HIV/AIDS who are not otherwise eligible for services, how Medicaid expansion and 1115 waivers will affect the Ryan White HIV/AIDS Program, and how waivers have prepared states to implement the Affordable Care Act. 2014-08-31-04:00 Active Jodi Duckhorn 301 443-1984 No No No 280 560 0

Discussion Guides No Health Illness Prevention
1 State medicaid Agency Groups Yes Yes Paper Only Form and instruction B_Medicaid Discussion Guide.docx 2 RW Part A Administrators and Members of Planning Councils Yes Yes Paper Only Form and instruction C_RW PART A Discussion Guide.docx 4 RW Clinical Providers Yes Yes Paper Only Form and instruction E_RW PART C Discussion Guide.docx 3 RW Part B and ADAP Yes Yes Paper Only Form and instruction D_RW PART B Discussion Guide.docx
State, Local, and Tribal Governments 280 560 0

2013-08-23-04:00

0915-0366 201307-0915-003 0915
             
        "Survey of Eligible Users of the National Practitioner Databank"
             
          
        
The purpose of this survey is to assess the overall satisfaction of the eligible users of the NPDB. This survey will evaluate the effectiveness of the NPDB as a flagging system, source of information, and use in decision making. Furthermore, this survey will collect information from eligible non-users of the NPDB/HIPDB to understand what can be done to aid the eligible non-users in registering, accessing, and using the information available. 2016-09-30-04:00 Active Jodi Duckhorn 301 443-1984 No Yes No 16400 4951 0

Self-Query Survey No Health Illness Prevention
1 Self-Query Survey Yes Yes Fillable Fileable Form and instruction Self-Query_Survey.docx
Individuals or Households 1200 134 0

User Non-User Survey No Health Illness Prevention
2 User Non-User Survey Yes Yes Fillable Fileable Form and instruction User_Nonuser_Survey.docx
State, Local, and Tribal Governments 15200 4817 0

2013-09-16-04:00

0915-0367 201308-0915-002 0915
             
        "The Teaching Health Center Graduate Medical Education (THCGME) Program Eligible Resident/FTE Chart"
             
          
        
The THCGME Program Eligible Resident/FTE Chart published in the THCGME Funding Opportunity Announcements (FOAs) is a means for determining the number of eligible residents/FTEs in an applicant's primary care residency program. The chart requires applicants to provide data related to the size and/or growth of the residency program over previous academic years, the number of residents enrolled in the program during the baseline academic year, and a projection of the program's proposed expansion over the next four academic years. It is imperative that applicants complete this chart and provide evidence of a planned expansion, as per the statute, THCGME funding may only be used to support an expanded number of residents in a residency program. Utilization of a chart to gather this important information has decreased the number of errors in the eligibility review process resulting in more accurate review and funding process. The respondents are applicants for the THCGME program. 2016-09-30-04:00 Active Jodi Duckhorn 301 443-1984 No Yes No 25 13 0

The Teaching Health Center Graduate Medical Education (THCGME) Program Eligible Resident/FTE Chart No Health Consumer Health and Safety
1 The Teaching Health Center Graduate Medical Education (THCGME) Program Eligible Resident/FTE Chart Yes Yes Fillable Fileable Form and instruction Instructions for FTE Chart FINAL.docx
Private Sector 25 13 0

2013-09-16-04:00

0915-0368 201305-0915-003 0915
             
        "Health Center Patient Survey"
             
          
        
The Health Center Patient Survey will gather information that will assist policymakers assessment of how well HRSA supported health centers are able to meet health care needs and complement data that are not routinely collected from other HRSA data sources. The cognitive pre-test will refine and test the survey instrument, test the survey sampling methodologies and procedures before it is implemented nationally. The respondents are Health Center patients from different racial/ethnic backgrounds. 2016-09-30-04:00 Active Jodi Duckhorn 301 443-1984 No No No 161 95 0

Patient Screening Form No Health Illness Prevention
1 Patient Screener Yes Yes Fillable Fileable Form Patient Screening Form41913.doc
Individuals or Households 92 9 0

Patient Survey Instrument No Health Illness Prevention
1 Patient Survey Yes Yes Fillable Fileable Form and instruction 2014 HC Patient_Survey_01APRIL2013 (2).docx
Individuals or Households 69 86 0

2013-09-17-04:00

0915-0369 201308-0915-003 0915
             
        "Estimating the Gap Between the Needs of Children and Health Coverage and Benefits Through Implementation of the Affordable Care Act"
             
          
        
The proposed data collection form has been developed to collect health care services budget information from Title V MCH Block Grant recipients to better understand the types of direct services currently provided by Title V MCH programs. The respondents to the survey will be the Title V Program Directors in the States, the District of Columbia and Puerto Rico. 2016-10-31-04:00 Active Jodi Duckhorn 301 443-1984 No Yes No 52 1872 0

Title V Survey No Health Illness Prevention
1 survey Yes Yes Fillable Fileable Form and instruction Title V Survey.docx
State, Local, and Tribal Governments 52 1872 0

2013-10-24-04:00

0915-0370 201306-0915-003 0915
             
        "Primary Care Faculty Development Initiative"
             
          
        
HRSA is facilitating the Primary Care Faculty Development Initiative to develop, implement and evaluate needed improvements in health care delivery. PCFDI surveys will review the planned curriculum and its implementation, and make recommendations to improve teaching and competency assessment. Respondents include selected teams of internal medicine, pediatric, and family medicine physicians at the four pilot site institutions. 2016-11-30-05:00 Active Jodi Duckhorn 301 443-1984 No No No 36 15 0

PCFDI Faculty Skill and Program Feasibility Survey No Health Health Care Services
1 PCFDI Faculty Skill and Program Feasibility Survey Yes Yes Fillable Fileable Form PCFDI Faculty Skill Feasibility Survey Final.docx 2 PCFDI Irvine's Leadership Behavior Survey Yes Yes Fillable Fileable Form PCFDI Leadership Behavior Survey final.docx
Private Sector 36 15 0

2013-11-08-05:00

0915-0371 201309-0915-001 0915
             
        "Develop and Implement UCARE4LIFE Message Library"
             
          
        
Easily implemented interventions are needed for HIV self-management. The information collected will be used to: 1) develop, test, and maintain a message library that addresses topics of HIV disease self-management and risk reduction and 2) develop, implement, conduct, and evaluate the text messaging. Respondents are racially and ethnically diverse HIV positive youth and young adults and health care providers. 2015-12-31-05:00 Active Jodi Duckhorn 301 443-1984 No No No 3290 1969 0

Patient Focus Group Screener - Small Group Discussion Screener No Health Health Care Services
1 Small Group Discussion Screener Yes Yes Paper Only Form and instruction AppendixB_SmallGroupDiscussionScreener.docx
Individuals or Households 128 32 0

Patient Focus Group Interview - Small Group Discussion Interview Guide No Health Health Care Services
1 Small Group Discussion Guide Yes Yes Printable Only Form and instruction AppendixC_SmallGroupDiscussionGuide.docx
Individuals or Households 32 64 0

Patient Pilot Study Screener - Intervention Screener No Health Health Care Services
1 Survey Screener Yes Yes Paper Only Form and instruction 3 AppendixE_SurveyScreener.doc
Individuals or Households 1000 250 0

Patient Pilot Study Surveys - Web based surveys No Health Health Care Services
1 Pattient Baseline Yes Yes Fillable Fileable Form and instruction 4 AppendixF_BaselinePatientSurvey.docx 2 Patient Follow-up Yes Yes Fillable Fileable Form and instruction 4 AppendixG_FollowUpPatientSurvey.docx
Individuals or Households 2000 1500 0

Patient Pilot Study Qualitative Interviews - In Depth Interview Guide for Intervention Cases No Health Health Care Services
1 Patient Interview Guide Yes Yes Paper Only Form and instruction 5 AppendixO_PatientInterviewGuide.docx
Individuals or Households 100 100 0

Clinic Staff Pilot Study Qualitative Interviews - Provider Qualitative Interview Guide No Health Health Care Services
1 Clinical Interview Guide Yes Yes Paper Only Form and instruction 6 AppendixH_ClinicStaffInterviewGuide.doc
Individuals or Households 30 23 0

2013-12-02-05:00

0915-0372 201302-0915-002 0915
             
        "NHSC Site Retention Assessment Questionnaire"
             
          
        
The purpose of the NHSC Site Retention Assessment Questionnaire is to collect survey information from administrative officials at NHSC sites that will guide NHSC initiatives and assist sites in improving their retention outcomes. The survey will ask site administrators to rate how difficult it is to retain clinicians, their general attitudes about the feasibility of good retention and awareness of its principles, their practices' current approaches to promoting retention, ratings on various aspects of their practices' organizational culture and administrative style, and their sites' interest in and preferred ways of learning how to bolster retention. Survey data will be gathered anonymously and presented in-aggregate, to promote administrators' participation and full disclosure. 2016-12-31-05:00 Active Jodi Duckhorn 301 443-1984 No No No 7000 3549 0

NHSC Site Retention Assessment Questionnaire No Health Illness Prevention
1 NHSC Site Retention Assessment Questionnaire No Fillable Fileable Form and instruction NHSC Site Retention Assessment Questionnaire_FINAL_amended_12132013.pdf
Private Sector 7000 3549 0

2013-12-18-05:00

0915-0373 201310-0915-001 0915
             
        "National Hospital Organ Donation Campaign's Activity Scorecard"
             
          
        
The Hospital Campaign Activity Scorecard was developed to: 1) motivate and assist hospitals to conduct donor registration activities by providing a turn-key menu of outreach strategies to simplify and facilitate activity implementation, 2) provide a basis for reward and recognition, and 3) evaluate the Hospital Campaign efforts. 2017-01-31-05:00 Active Jodi Duckhorn 301 443-1984 No No No 1000 367 0

Hospital Campaign Activity Scorecard No Health Illness Prevention
1 Hospital Campaign Activity Scorecard Yes Yes Fillable Fileable Form and instruction ChallengeScorecard_Form_090513.pdf
State, Local, and Tribal Governments 1000 367 0

2014-01-22-05:00

0915-0374 201311-0915-005 0915
             
        "Nurse Anesthetist Traineeship (NAT) Program"
             
          
        
The NAT grant program provides traineeship support for licensed registered nurses enrolled as full-time students in a master's or doctoral nurse anesthesia program. Traineeships will pay the cost of the tuition, books, and fees, and the reasonable living expenses (stipends) of trainees. The funds appropriated are distributed based on a formula. HRSA uses the data from the application, and the NAT Tables to determine the award, ensure programmatic compliance, and provide information to the public and Congress. 2017-01-31-05:00 Active Jodi Duckhorn 301 443-1984 No Yes No 100 774 0

NAT Forms No Health Consumer Health and Safety
1 Table 1 Yes Yes Fillable Fileable Form and instruction Table 1 NAT forms.docx 2A Table 2A Yes Yes Fillable Fileable Form and instruction Table 2A NAT Forms.docx 2B Table 2B Yes Yes Fillable Fileable Form and instruction Table 2B NAT forms.docx
State, Local, and Tribal Governments 100 774 0

2014-01-27-05:00

0915-0375 201311-0915-002 0915
             
        "Advanced Education Nursing Traineeship (AENT) Program"
             
          
        
The Advanced Education Nursing Traineeship (AENT) Program purpose is to increase the number of primary care providers by providing traineeships to nurses who are pursuing advanced degrees as primary care nurse practitioners (NP) or nurse-midwives. Applicants apply for a two year grant to prepare primary care nurse practitioners. Eligible applicants are collegiate schools of nursing, nursing centers, academic health centers, State or local governments and other private or public entities determined appropriate by the Secretary that submit to the Secretary an application in accordance with section 802 [of the Public Health Service Act]. 2017-01-31-05:00 Active Jodi Duckhorn 301 443-1984 No Yes No 70 882 0

AENT Program Forms No Health Consumer Health and Safety
1B Rural Underserve or PH settings graduates supported with instructions Yes Yes Fillable Fileable Form and instruction Table 1B Rural Underserved or PHealth Practice Settings Graduates Supported .docx 4 dec 13.docx 2A 2a projected master degree and post nursing master students with instructions Yes Yes Fillable Fileable Form and instruction Table 2 A Projected Masters Degree and Post Nursing Masters .docx 4 dec 13.docx 2B 2b projected doctoral degree students with instructions Yes Yes Fillable Fileable Form and instruction Table 2B Projected Doctoral Degree Students with Instructions.docx 4 dec 13.docx 1A Rural Underserved or PH practice settings; Graduate data with instructions Yes Yes Fillable Fileable Form and instruction Table 1A Rural Underserved or PH Practice Settings Graduates .docx 4 dec 13.docx
State, Local, and Tribal Governments 70 882 0

2014-01-27-05:00

0917-0002 201302-0917-001 0917
             
        "IHS Contract Health Service Report"
             
          
        
The information collected is needed to administer and manage the contract health care services provided to eligible AI/AN patients. The form is used to: authorize contract health care services for eligible patients; certify that the health care services requested and authorized have been performed by the contract provider(s); process payments for health care services performed by such providers; obtain program data; and, serve as a legal document for health and medical care authorized by the IHS and rendered by health care providers under contract with the IHS. The information collected is also used for planning for further care of the patient, for keeping an accurate record of the patient's health status and health services received and recommended, for planning future health care programs, for communicating among members of the health care team, for evaluating the health care rendered, for research and continuing education and for the provision of program health statistics. 2016-04-30-04:00 Active Tamara Clay Tamara.Clay@ihs.gov 301 443-4750 No No No 414804 20740 0

Order for Health Services No Health Health Care Services
IHS-843-1A Order for Health Services Yes Yes Fillable Printable Form and instruction IHS-843-1A -Order for Health Services-Rev-June2009.pdf
Private Sector 0 0 0

Inpatient Discharge Summary No Health Health Care Services Private Sector 0 0 0

IHS-843-1A, Order for Health Services No Health Illness Prevention
OMB No. 0917-0002, IHS 843-1A OMB No. 0917-0002, IHS 843-1A, Order for Health Service http://www.ihs.gov/puf/ Yes No Fillable Printable Form and instruction Final IHS-843-1A_Order_For_Health_Services_FORM Double-sided 5 pages-Jan 15-2013 (2).doc
Private Sector 414804 20740 0

2013-04-10-04:00

0917-0006 201308-0917-001 0917
             
        "Application for Participation in the IHS Scholarship Program"
             
          
        
Program forms collect information used to solicit, process and award scholarships, monitor academic performance and place awardees in payback sites. The data is needed to plan, manage, direct, operate and evaluate the IHSA Scholarship program. 2016-09-30-04:00 Active Tamara Clay Tamara.Clay@ihs.gov 301 443-4750 No No No 12580 4340 0

Scholarship Application No Education Higher Education
NA IHS Form 856 No No Paper Only Form IHS Form 856.pdf
Individuals or Households 0 0 0

Application Checklist No Education Higher Education
IHS-856-2 Application Checklist No No Paper Only Form IHS-856-2 Application Checklist.pdf
Individuals or Households 0 0 0

Narrative Statements No Education Higher Education
IHS-856-4 Narrative Statements No No Paper Only Form IHS-856-4 NARR STATEMENTS.pdf
Individuals or Households 0 0 0

Delinquent Federal Debt No Education Higher Education
IHS-856-5 Delinquent Federal Debt No No Paper Only Form IHS-856-5 DELINQ FED DEBT.pdf
Individuals or Households 1500 200 0

Verification of Acceptance or Decline of Award No Education Higher Education
IHS-856-7 Verification of Acceptance or Decline of Award No No Paper Only Form IHS-856-7 VERF ACCEP DECLINE.pdf
Individuals or Households 500 67 0

Recipient's Initial Program Progress Report No Education Higher Education
ihs-856-8 Recipient's Initial Program Progress Report No No Paper Only Form IHS-856-8 RECP INIT PRGM PROG RPT.pdf
Individuals or Households 1200 160 0

Notification of Academic Problem No Education Higher Education
IHS-856-9 Notification of Academic Problem No No Paper Only Form IHS-856-9 NOTICE OF ACAD PROBLEM.pdf
Individuals or Households 50 7 0

Change of Status No Education Higher Education
IHS-856-10 Change of Status No No Paper Only Form IHS-856-10 CHANGE OF STATUS.pdf
Individuals or Households 50 21 0

Request for Approval of Deferment No Education Higher Education
HS-856-11 Request for Approval of Deferment No No Paper Only Form IHS-856-11 REQ FOR APPR OF DEFER.pdf
Individuals or Households 20 3 0

Preferred Placement No Education Higher Education
IHS-856-12 Preferred Placement No No Paper Only Form IHS-856-12 PREFERRED PLACEMENT.pdf
Individuals or Households 150 75 0

Notice of Impending Graduation No Education Higher Education
IHS-856-13 Notice of Impending Graduation No No Paper Only Form IHS-856-13 NOTICE OF IMPEND GRAD.pdf
Individuals or Households 170 28 0

Notification of Deferment Program No Education Higher Education
IHS-856-14 Notification of Deferment Program No No Paper Only Form IHS-856-14 NOTICE OF DEF PRG.pdf
Individuals or Households 20 3 0

Placement Update No Education Higher Education
IHS-856-15 Placement Update No No Paper Only Form IHS-856-15 PLACEMENT UPDATE.pdf
Individuals or Households 170 31 0

Annual Status Report No Education Higher Education
IHS-856-16 Annual Status Report No No Paper Only Form IHS-856-16 ANNUAL STAT RPT.pdf
Individuals or Households 200 50 0

Extern Site Preference Request No Education Higher Education
IHS-856-17 Extern Site Preference Request No No Paper Only Form IHS-856-17 EXT SITE PREF REQ.pdf
Individuals or Households 300 40 0

Request for Extern Travel Reimbursement No Education Higher Education
IHS-856-18 Request for Extern Travel Reimbursement No No Paper Only Form IHS-856-18 REQ EXT TRAVEL REIMBURSE.pdf
Individuals or Households 150 15 0

Lost Stipend Payment No Education Higher Education
IHS-856-19 Lost Stipend Payment No No Paper Only Form IHS-856-19 LOST STIPEND PYMT.pdf
Individuals or Households 50 7 0

Request for Tutorial Assistance No Education Higher Education
IHS-856-20 Request for Tutorial Assistance No No Paper Only Form IHS-856-20 REQ FOR TUTOR ASST.pdf
Individuals or Households 0 0 0

Summer School Request No Education Higher Education
IHS-856-21 Summer School Request No No Paper Only Form IHS-856-21 SUMMER SCH REQ.pdf
Individuals or Households 100 10 0

Change of Name or Address No Education Higher Education
IHS-856-22 Change of Name or Address No No Paper Only Form IHS-856-22 CHANGE OF NAME OR ADD.pdf
Individuals or Households 20 3 0

Request for Credit Validation No Education Higher Education
IHS-856-23 Request for Credit Validation No No Paper Only Form IHS-856-23 REQ FOR CREDIT VALID.pdf
Individuals or Households 30 3 0

Faculty/Advisor Evaluation No Education Higher Education
IHS-856-24 Faculty-Advisor Evaluation No No Paper Only Form IHS-856-24 FAC ADV EVAL.pdf
Individuals or Households 3000 1250 0

Acknowledgment Card No Education Higher Education
IHS-815 Acknowledgment Card No No Paper Only Form IHS-815 and 816 Change of Address.pdf
Individuals or Households 0 0 0

Address Change Notice No Education Higher Education
IHS-816 Address Change Notice No No Paper Only Form IHS-815 and 816 Change of Address.pdf
Individuals or Households 0 0 0

Scholarship Program Agreement No Education Higher Education
IHS-817 Scholarship Program Agreement No No Paper Only Form IHS-817 Scholarship Program Agreement.pdf
Individuals or Households 175 29 0

Health Professions Contract No Education Higher Education
IHS-818 Health Professions Contract No No Paper Only Form IHS-818 Scholarship Program Contract.pdf
Individuals or Households 225 38 0

Faculty/Employer Evaluation No Education Higher Education
IHS-856-3 Faculty/Employer Evaluation No No Paper Only Form IHS-856-3 FAC EMPL EVAL.pdf
Individuals or Households 3000 1250 0

Course Curriculum Verification No Education Higher Education
IHS-856-6 Course Curriculum Verification No No Paper Only Form IHS-856-6 COURSE CURR VERF.pdf
Individuals or Households 1500 1050 0

2013-09-30-04:00

0917-0007 201108-0917-001 0917
             
        "IHS Urban Indian Health Program Common Reporting Requirements"
             
          
        
Information required to assess the quality of healthcare services, and are likely already familiar to, and may already be in use by UIHP grantees. 2014-10-31-04:00 Active Tamara Clay Tamara.Clay@ihs.gov 301 443-4750 No No No 33 792 0

IHS Urban Indian Health Program Common Reporting Requirements No Health Public Health Monitoring
0917-0007 UDS Reporting Instructions for OUIHP Programs No No Printable Only Form and instruction 2010 UIHP Manual _2011Feb 17 2011 final.doc
State, Local, and Tribal Governments 33 792 0

2011-10-23-04:00

0917-0009 201306-0917-001 0917
             
        "Indian Health Service Medical Staff Credentials and Privileges Files"
             
          
        
National health care standards developed by the Center for Medicare and Medicaid Services (CMS), the Joint Commission and other accrediting organizations require health care facilities to review, evaluate and verify the credentials, training and experience of medical staff applicants prior to granting medical staff privileges. To meet these standards, IHS health care facilities require all medical staff applicants to provide information concerning their education, training, licensure, and work experience and any adverse disciplinary actions taken against them. This information is then verified with references supplied by the applicant and may include: former employers, educational institutions, licensure and certification boards, the American Medical Association, the Federation of State Medical Boards, the National Practitioner Data Bank, and the applicants themselves. 2016-08-31-04:00 Active Tamara Clay Tamara.Clay@ihs.gov 301 443-4750 No No No 3068 1784 0

Indian Health Service Medical Staff Credentials and Privileges Files No Health Public Health Monitoring
0917-0009-1 Application for Medical Staff Appointment and/or Privileges http://www.ihs.gov/RiskManagement/index.cfm?module=dsp_rm_resources Yes No Fillable Printable Form and instruction IHS_Medi1 PDF.pdf
Individuals or Households 570 570 0

Reference Letter No Health Public Health Monitoring
0917-0009-2 0917-0009-2, References Form No No Paper Only Form and instruction References_form[1].doc
Individuals or Households 1710 570 0

Reaapointment Request No Health Public Health Monitoring
0917-0009-3 0917-0009-3, Reappointment Request Form No No Paper Only Form and instruction Request_for_Reappointment_form[1].doc
Individuals or Households 190 190 0

Medical Privileges Request Form No Health Public Health Monitoring
0917-0009-4 0917-0009-4, Medical Privileges Request Form No No Paper Only Form and instruction Medical_privileges_request_form[1].doc
Individuals or Households 325 325 0

OB-GYN No Health Public Health Monitoring
0917-0009-5 0917-0009-5, OB-GYN Privileges Form No No Paper Only Form and instruction OB-GYN_privileges_request_form[1].doc
Individuals or Households 20 20 0

Surgery No Health Public Health Monitoring
0917-0009-6 0917-0009-6, Surgical Privileges Request Form No No Paper Only Form and instruction Surgical_privileges_request_form[1].doc
Individuals or Households 20 20 0

Psychiatry No Health Public Health Monitoring
0917-0009-7 0917-0009-7, Psychiatric Privileges Request Form No No Paper Only Form and instruction Psychiatric_privileges_request_form[2].doc
Individuals or Households 13 13 0

Anesthesis No Health Public Health Monitoring
0917-0009-8 0917-0009-8, Anesthesia Privileges Request Form No No Paper Only Form and instruction Anesthesia_privileges_request_form[1].doc
Individuals or Households 15 15 0

Dental Privileges No Health Illness Prevention
0917-0009-9 0917-0009-9, Dental Privleges Request Form No No Paper Only Form and instruction Dental_privileges_request_form[1].doc
Individuals or Households 150 50 0

Optometry No Health Illness Prevention
NA Optometric Privileges Request Form No No Paper Only Form Optometric privileges request form.doc
Individuals or Households 0 0 0

Psychology No Health Illness Prevention
0917-0009-11 OMB 0917-0009-11, Psychology Privileges Request Form No No Paper Only Form and instruction Psychology_privileges_request_form[1].doc
Individuals or Households 30 5 0

Audiology No Health Illness Prevention
0917-0009-12 OMB No. 0917-0009-12, Audiology Privileges Request Form No No Paper Only Form and instruction Audiologic_privileges_request_form[1].doc
Individuals or Households 7 1 0

Podiatry No Health Illness Prevention
0917-0009-13 OMB Form No. 0917-0009-14, Podiatric Privileges Request Form No No Paper Only Form and instruction Podiatric_privileges_request_form[1].doc
Individuals or Households 7 1 0

Radiology No Health Illness Prevention
0917-0009-14 OMB No. 0917-0009-14, Radiolgy Privileges Request Form No No Paper Only Form and instruction Radiology_privileges_request_form[2].doc
Individuals or Households 8 3 0

Pathology No Health Illness Prevention
0917-009-15 OMB No. 0917-0009-15, Pathology Privileges Request Form No No Paper Only Form and instruction Pathology_privileges_request_form[1].doc
Individuals or Households 3 1 0

2013-08-16-04:00

0917-0014 201205-0917-001 0917
             
        "Indian Health Service Loan Repayment Program"
             
          
        
The Indian Health Service (IHS) Loan Repayment Program (LRP) identifies health professionals with pre-existing financial obligations for education expenses that meet program criteria and who are qualified and willing to serve at, often remote, IHS health care facilities. Under the program, eligible health professionals sign a contract under which the IHS agrees to repay part or all of their indebtedness for professional training education. In exchange, the health professionals agree to serve for a specified period of time in IHS health care facilities. This information collection covers the application process for this program. 2015-07-31-04:00 Active Tamara Clay Tamara.Clay@ihs.gov 301 443-4750 No No No 510 765 0

IHS Loan Application No Education Higher Education
0917-0014 Financial information https://www.ihs.gov/loanrepayment/lrpOnlineApp/ Yes Yes Fillable Fileable Form financial.pdf 0917-0014 Education Information https://www.ihs.gov/loanrepayment/lrpOnlineApp/ Yes Yes Fillable Fileable Form education.pdf 0917-0014 General Applicant Information https://www.ihs.gov/loanrepayment/lrpOnlineApp/ No No Fillable Fileable Form general_applicant_info.pdf
Individuals or Households 510 765 0

2012-07-16-04:00

0917-0028 201209-0917-001 0917
             
        "IHS Background Investigations of Individuals in Positions Involving Regular Contact with or Control Over Indian Children"
             
          
        
To collect information needed to determine whether a prospective or current employee that has regular contact with or control over Indian children meets the minimum standards or character and to conduct background investigation. 2015-11-30-05:00 Active Tamara Clay Tamara.Clay@ihs.gov 301 443-4750 No No No 3000 600 0

IHS Background Investigation of Individuals in Positions Involving Regular Contact with or Control Over Indian Children No Workforce Management Training and Employment
0917-0028 Addendum to Declaration for Federal Employment (OF 306) ; IHS Child Care and Indian Child Care Worker Positions" http://www.ihs.gov/Jobs/permanentDocs/ChildcareAddendumOMBApprovedForm-2012.doc Yes No Printable Only Form and instruction Final_OMB_0917-0028_2015_Version_7-10-2012.doc
Individuals or Households 3000 600 0

2012-11-07-05:00

0917-0030 201301-0917-002 0917
             
        "IHS Forms To Implement The Privacy Rule (45 CFR Parts 160 and 164)"
             
          
        
This is a request for an extension without a revision of a previously approved collection which is due to expire January 31, 2013. This collection of information is made necessary by the Department of Health and Human Services Rule entitled Standards for Privacy of Individually Identifiable Health Information (A Privacy Rule) (45 CFR Parts 160 and 164). The Privacy Rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 and creates national standards that protect patient health information and gives our patients access to their health information. 2016-04-30-04:00 Active Tamara Clay Tamara.Clay@ihs.gov 301 443-4750 No No No 542500 174375 0

IHS-810, Authorization for Use or Disclosure of Protected Health Information No Health Health Care Services
0917-0030, IHS-810 Authorization for Use or Disclosure of Protected Health Information http://www.ihs.gov/CIO/PUF/ Yes No Fillable Printable Form and instruction IHS-810_508.pdf
Individuals or Households 500000 166667 0

IHS-912-1, Request for Restriction(s) No Health Health Care Services
0917-0030, IHS-912-1 Request for Restrictions(s) http://www.ihs.gov/CIO/PUF/ Yes No Fillable Printable Form and instruction IHS-912-1_508.pdf
Individuals or Households 15000 2500 0

IHS-912-2, Request for Revocation of Restriction(s) No Health Health Care Services
0917-0030-IHS-912-2 Request for Revocation of Restriction(s) http://www.ihs.gov/CIO/PUF/ Yes No Fillable Printable Form and instruction IHS-912-2_508.pdf
Individuals or Households 5000 833 0

IHS- 913, Request for Accounting of Disclosures No Health Health Care Services
0917-0030 Request for Accounting Disclosures http://www.ihs.gov/CIO/PUF/ Yes No Fillable Printable Form and instruction IHS-913_508.pdf
Individuals or Households 15000 2500 0

IHS- 917, Request for Correction/Amendment of Protected Health Information No Health Health Care Services
0917-0030, IHS-917 Request for Correction/Amendment of Protected Health Information http://www.ihs.gov/CIO/PUF/ Yes No Fillable Printable Form and instruction IHS-917_508.pdf
Individuals or Households 7500 1875 0

2013-04-01-04:00

0917-0034 201211-0917-001 0917
             
        "Sharing What Works - Best Practice, Promising Practice, and Local Effort (BPPPLE) "
             
          
        
The Indian Health Service (IHS) goal is to raise the health status of the American Indian and Alaska Native (AI/AN) people to the highest possible level by providing comprehensive health care and preventive health services. To support the IHS mission and to provide the product/service to IHS, Tribal, and Urban (I/T/U) programs, the Office of Clinical and Preventive Services (OCPS) program divisions (i.e., Behavioral Health (BH), Health Promotion/Disease Prevention (HP/DP), Nursing, and Dental) have developed a centralized program database consisting of Best and Promising Practices and Local Efforts (BPPPLE), resources, and policies. The purpose of this collection is to further the development of a database of BPPPLE, resources, and policies which are available to the public on the IHS.gov website. This database will be a resource for program evaluation and for modeling examples of various health care projects occurring in AI/AN communities. 2016-01-31-05:00 Active Tamara Clay Tamara.Clay@ihs.gov 301 443-4750 No No No 100 33 0

0917-0034, Sharing What Works - Best Practice, Promising Practice, and Local Efforts (BPPPLE) No Health Illness Prevention
0917-0034 0917-0034-Sharing What Works - Best Practice, Promising Practice, and Local Effort (BPPPLE) http://www.ihs.gov/OSCAR/index.cfm?module=formpg1 Yes No Fillable Fileable Form and instruction OMB_Form_No__0917-0034_IHS_BPPPLE_____11-13-12[1].docx
Individuals or Households 100 33 0

2013-01-25-05:00

0917-0036 201301-0917-001 0917
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery"
             
          
        
This fast track generic collection of infomration is neccesssary to enable IHS to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficeint, and satisfying experience with the Agency's programs. 2015-05-31-04:00 Active Tamara Clay Tamara.Clay@ihs.gov 301 443-4750 No No No 105000 40000 0

Community Health Representatives (CHR) Online Diabetes Training Evaluation No Health Health Care Services
OMB No. 0917-0036-16 OMB No. 0917-0036-16, IHS CHR Online Diabetes Training Evaluation Form Yes Yes Fillable Fileable Form and instruction OMB No. 0917-0036-16, IHS CHR Diabetes Online Training Evaluation Form.docx
Individuals or Households 110 9 0

IHS Pharmacy Automation Survey 2013 No Health Health Care Services
OMB No. 0917-0036-19 OMB No. 0917-0036-19, IHS Pharmacy Automation Survey Yes Yes Fillable Fileable Form and instruction OMB No. 0917-0036-19, IHS Pharmacy Automation Survey.pdf
Federal Government 200 33 0

IHS OEHE Customer Satisfaction Survey No Health Health Care Services
0917-0036-20 0917-0036-20, Post Construction O & M Survey Yes Yes Fillable Fileable Form and instruction 0917-0036-20, Post Construction O & M Survey.doc 0917-0036-20 0917-0036-20, Annual Operator O & M Survey Yes Yes Fillable Fileable Form and instruction 0917-0036-20, Annual Operator O & M Survey.doc 0917-0036-20 0917-0036-20, Tribal Homeowner Survey Yes Yes Fillable Fileable Form and instruction 0917-0036-20, Tribal Homeowner Survey.doc 0917-0036-20 0917-0036-20, Tribal Partner Survey Yes Yes Fillable Fileable Form and instruction 0917-0036-20, Tribal Partner Survey.doc
State, Local, and Tribal Governments 1800 90 0

Community Health Representatives (CHR) National Education Training (NET) No Health Health Care Services
0917-0036-17 OMB No. 0917-0036-17, IHS CHR NET Plenary Eval Form Yes Yes Fillable Fileable Form and instruction OMB No. 0917-0036-17, IHS CHR NET Plenary Evaluation Form.doc
Individuals or Households 325 43 0

IHS Clinical Rounds Qualitative Feedback No Health Health Care Services
0917-0036-18 0917-0036-18, IHS Clinical Rounds Qualitative Feedback Form Yes Yes Fillable Fileable Form and instruction IHS Clinical Rounds Qualitative Feedback - Survey Monkey - VIRTUAL FORM 4-8-2013.pdf
Individuals or Households 500 83 0

Portland Area Division of Environmental Health Services: Customer Service Assessment No Health Illness Prevention
0917-0036-21 OMB No 0917-0036-21, Portland Area Division of Environmental Health Services: Customer Services Assessment Yes Yes Fillable Fileable Form and instruction OMB No. 0917-0036-21, Portland Area Division of Environmental Health Services Customer Services Assessment.pdf
Individuals or Households 60 15 0

VPN User Survey No Health Public Health Monitoring
OMB No. 0917-0036-22 OMB Form No. 0917-0036-22, IHS VPN User Survey https://www.surveymonkey.com/s/CGBDGW9 Yes Yes Fillable Fileable Form and instruction OMB No 0917-0036-22 IHS VPN User Survey.docx
Individuals or Households 220 18 0

RPMS Annual Training Needs Assessment No Health Public Health Monitoring
0917-0036-23 OMB No. 0917-0036-23, IHS RPMS Annual Training Needs Assessment Yes Yes Fillable Fileable Form and instruction OMB 0917-0023 IHS RPMS Annual_Training_Needs_Assessment.pdf
Federal Government 550 92 0

Indian Health Service (IHS) Patient Experience Survey No Health Health Care Services
OMB No. 0917-0036-24 OMB No. 0917-0036-24, IPC Patient Experience Survey No No Paper Only Form and instruction OMB 0917-0036-24, IPC Patient Experience Survey Form.docx
Individuals or Households 480 40 0

IHS Website ICD-10 Stakeholder Readiness Survey - ICD-10 Project Needs Assessment No Health Illness Prevention
0917-0036-27 OMB No. 0917-0036-27, IHS Website ICD-10 Stakeholder Readiness Survey - ICD-10 Project Needs Assessment No No Fillable Fileable Form and instruction OMB No. 0917-0036-27, IHS Website ICD-10 Stakeholder Readiness Survey - ICD-10 Project Needs Assessment.docx
Federal Government 500 83 0

RPMS Computer Based Post Class Survey No Health Illness Prevention
0917-0036-28 0917-0036-28, Computer Training Post Class Survey Yes Yes Fillable Fileable Form and instruction OMB 0917-0036-28, CBT Survey.pdf
Federal Government 2500 208 0

RPMS eLearning Hands-on Customer Satisfaction Survey No Health Illness Prevention
OMB No. 0917-0036-30 OMB No. 0917-0036-30, RPMS eLearning Hands-on Customer Satisfaction Survey Yes Yes Fillable Fileable Form and instruction OMB No. 0917-0036-30, RPMS eLearning Hands-on Customer Satisfaction Survey.pdf
Federal Government 2500 208 0

Patient Satisfaction Survey, at CRHC No Health Health Care Services
0917-0036-32 Patient Satisfaction Survey, at Cheyenne River Health Center No No Paper Only Form and instruction OMB No. 0917- 0036-32, Patient Satisfaction Survey.docx
Individuals or Households 540 45 0

Patient Flow Time Study No Health Health Care Services
0917-0036-33 Patient Flow Time Study No No Paper Only Form and instruction OMB No. 0917-0036-33, Time Study_Patient Flow_.docx
Individuals or Households 540 45 0

2013-01-31-05:00

0917-0037 201305-0917-001 0917
             
        "INDIAN SELF-DETERMINATION AND EDUCATION ASSISTANCE CONTRACTS, 25 C.F.R. PART 900"
             
          
        
This previously approved information collection project was published in the Federal Register (78 FR 15035), as a joint submission with the Bureau of Indian Affairs (BIA), under OMB Control Number 1076-0136, on March 8, 2013 and allowed 60 days for public comment, as required by 3506(c)(2)(A). In the past, BIA was the lead for this ICR, and submitted the request on behalf of both BIA and IHS to the Department. As of May 2013, the IHS is pursuing its own OMB Control Number for this information collection and will submit information collection requests to OMB separately in the future. Representatives of the IHS seek renewal of the approval for information collections conducted under 25 C.F.R Part 900, implementing the Indian Self-Determination and Education Assistance Act (ISDEAA), as amended (25 U.S.C. 450 et seq.), which describes how contracts are awarded to Indian Tribes. The rule at 25 C.F.R. Part 900 was developed through negotiated rulemaking with Tribes in 1996 and governs, among other things, what must be included in a Tribe's initial ISDEAA contract proposal to IHS. A response is required to obtain and retain a benefit. Under the Act, the Secretary of Health and Human Services is directed to enter into self-determination contracts with Tribes upon request, unless specific declination criteria apply, and, generally, Tribes may renew these contracts annually. Additionally, IHS awards contracts for multiple programs. The IHS uses the information collected to determine applicant eligibility, evaluate applicant capabilities, protect the service population, safeguard Federal funds and other resources, and permit the Federal agency to administer and evaluate contract programs. Tribal governments or Tribal organizations provide the information by submitting contract proposals, and related information, to the IHS, as required under Public Law 93-638. 2016-07-31-04:00 Active Tamara Clay Tamara.Clay@ihs.gov 301 443-4750 No No No 1510 24112 0

INDIAN SELF-DETERMINATION AND EDUCATION ASSISTANCE CONTRACTS, 25 C.F.R. PART 900 No Health Illness Prevention State, Local, and Tribal Governments 1510 24112 0

2013-07-18-04:00

0920-0004 201401-0920-001 0920
             
        "National Disease Surveillance Program - II. Disease Summaries"
             
          
        
Due to the constant evolution of technology, laboratory testing and data management practices have changed substantially over the past several years. The currently approved form NREVSS 55.83 is now outdated and this change request is for approval of a new data collection form. 2014-08-31-04:00 Active Carol Marsh cww6@cdc.gov 404 639-4773 No No No 292746 56252 0

0920-0004 Influenza Annual Survey 55.31A No Health Public Health Monitoring
none Influenza Annual Survey Yes Yes Fillable Fileable Form Lab Survey.doc
State, Local, and Tribal Governments 86 22 0

0920-0004 Diarrheal Diseases Campylobacter No Health Public Health Monitoring
1 Diarrheal Disease Surveillance Campylobacter Yes Yes Fillable Printable Form Diarrheal PHLIS Campylobacter.jpg
State, Local, and Tribal Governments 2756 138 0

0920-0004 Diarrheal Diseases Salmonella No Health Public Health Monitoring State, Local, and Tribal Governments 2756 138 0

0920-0004 Diarrheal Diseases Shigella No Health Public Health Monitoring State, Local, and Tribal Governments 2756 138 0

0920-0004 Arboviral Diseases No Health Illness Prevention
none Arboviral Diseases Yes Yes Fillable Fileable Form and instruction ArboNet_Variable_List.2006-12-11(1).xls
State, Local, and Tribal Governments 80997 6750 0

0920-0004 National Enterovirus Surveillance Report 55.9 No Health Public Health Monitoring State, Local, and Tribal Governments 300 75 0

0920-0004 National Respiratory and Enteric Virus Surveillance System NREVSS 55.83A-D No Health Public Health Monitoring State, Local, and Tribal Governments 4680 780 0

0920-0004 Foodborne Outbreak 52.13 No Health Public Health Monitoring
CDC 52.13 National Outbreak Reporting System Yes Yes Fillable Fileable Form and instruction CDC Form 52.13_NORS Food, P2P, Animal_Proposed.pdf
State, Local, and Tribal Governments 1701 567 0

Rabies Monthly Report (paper) 55.28 No Health Public Health Monitoring State, Local, and Tribal Governments 36 9 0

Enhanced Animal Rabies Surveillance Monthly Report No Health Illness Prevention
55.28 Lab confirmed cases of rabies Yes Yes Fillable Fileable Form Enhanced Animal Rabies Surveillance.pdf
State, Local, and Tribal Governments 2704 135 0

0920-0004 Waterborne Diseases Outbreak 52.12 No Health Public Health Monitoring
CDC 52.12 National Outbreak Reporting System: Waterborne Disease Transmission Yes Yes Fillable Fileable Form and instruction Revised CDC 52.12 form Feb 2013.pdf
State, Local, and Tribal Governments 57 19 0

0920-0004 Cholera and Other Vibrio Illnesses 52.79 No Health Public Health Monitoring State, Local, and Tribal Governments 450 150 0

0920-0004 Suspected Viral Gastroenteritis (AKA Calicivirus Surveillance) No Health Public Health Monitoring State, Local, and Tribal Governments 100 8 0

0920-0004 Listeria Case Form No Health Public Health Monitoring State, Local, and Tribal Governments 53 27 0

HABISS No Health Public Health Monitoring
No number HABISS Yes Yes Fillable Printable Form Attachment 3 0920 0004 Change Request 9 22 08.doc
State, Local, and Tribal Governments 120 960 0

HABISS Monthly Reporting Form No Health Public Health Monitoring
No Number HABISS Report Yes Yes Fillable Printable Form Attachment 4 0920 0004 Change Request 9 22 08.doc
State, Local, and Tribal Governments 120 60 0

Babesiosis Case Report Form No Health Illness Prevention
none Babesiosis Case Report Form Yes Yes Fillable Fileable Form and instruction Babesiosis Case Report Form final.doc
State, Local, and Tribal Governments 648 108 0

Brucellosis Case Report Form No Health Illness Prevention
none Brucellosis Case Report Form Yes No Printable Only Form Brucellosis CRF Final-cleared Div Bran2.docx
State, Local, and Tribal Governments 112 37 0

Daily Novel and Pandemic Influenza Virus State Case Status Summary Update No Health Public Health Monitoring
none Daily Case Status Yes Yes Fillable Fileable Form Daily Novel Pandemic State.doc
State, Local, and Tribal Governments 57 14 0

Novel and Pandemic Influenza A Virus Infection Case Investigation Form No Health Public Health Monitoring
none Influenza A Case Investigation Yes Yes Fillable Fileable Form Novel and Pandemic Influenza Case Investigation Form.doc
State, Local, and Tribal Governments 57 29 0

Novel and Pandemic Influenza A Virus Infection Contact Trace Back Form No Health Public Health Monitoring
none Influenza A Trace Back Yes Yes Fillable Fileable Form Novel Pandemic Influenza A Trace Back Form.doc
State, Local, and Tribal Governments 57 29 0

Novel and Pandemic Influenza A Virus Infection Contact Trace Forward Form No Health Public Health Monitoring
none Trace Forward Yes Yes Fillable Fileable Signable Form Novel Pandemic Influenza A Trace Forward Form.doc
State, Local, and Tribal Governments 57 29 0

Human Infection with Novel Influenza A Virus Case Report Form No Health Public Health Monitoring
none Human Infection with Novel Influenza A Virus Case Report Form Yes Yes Fillable Fileable Form Human Infection with Novel Influenza A Virus Case Report Form.pdf
State, Local, and Tribal Governments 57 29 0

Possible Human Rabies - Patient Information Form No Health Public Health Monitoring
none Possible Human Rabies Yes Yes Fillable Fileable Form Possible Human Rabies Patient Information.pdf
State, Local, and Tribal Governments 50 13 0

Aggregate Hospitalization and Death Reporting Weekly No Health Public Health Monitoring
none Aggregate Hospital Yes Yes Fillable Fileable Form AHDRA Form.docx
State, Local, and Tribal Governments 2912 485 0

Influenza Virus Fax Oct-May 55.31 No Health Public Health Monitoring
Influenza Fax WHO Fax Form Yes Yes Fillable Printable Form WHO fax form.doc
State, Local, and Tribal Governments 165 28 0

Influenza virus fax year-round 55.31 No Health Public Health Monitoring
none WHO Fax Form Yes Yes Fillable Printable Form WHO fax form.doc
State, Local, and Tribal Governments 1092 182 0

Influenza virus Internet Oct - May 55.31 No Health Public Health Monitoring
none WHO Electronic Yes Yes Fillable Fileable Form WHO electronic form.doc
State, Local, and Tribal Governments 99 17 0

Influenza virus Internet Year-Round 55.31 No Health Public Health Monitoring
none WHO Electronic Form Yes Yes Fillable Fileable Form WHO electronic form.doc
State, Local, and Tribal Governments 1820 303 0

Influenza Associated Pediatric Death Case Report Form No Health Public Health Monitoring
none Pediatric Death Case Report Yes Yes Fillable Printable Form Pediatric Flu.doc
State, Local, and Tribal Governments 57 29 0

Influenza Virus Electronic year round - PHLIP No Health Public Health Monitoring State, Local, and Tribal Governments 260 22 0

Influenza Virus Electronic year round PHIN-MS No Health Public Health Monitoring State, Local, and Tribal Governments 884 74 0

Weekly Influenza-like Illness Oct - May 55.20 No Health Public Health Monitoring
55.20 Weekly Influenza-like Illness Yes Yes Fillable Printable Form Weekly ILI Reporting Form_55.20.doc
State, Local, and Tribal Governments 17820 4455 0

Weekly Influenza-like Illiness year round 55.20 No Health Public Health Monitoring
55.20 Weekly Influenza Like Illness Yes Yes Fillable Printable Form Weekly ILI Reporting Form_55.20.doc
State, Local, and Tribal Governments 65520 16380 0

Daily Influenza-like Illness Oct - May No Health Public Health Monitoring
none Influenza-like Illness Daily and year round Yes Yes Fillable Printable Form Daily ILI Reporting Form.doc
State, Local, and Tribal Governments 46200 11550 0

Daily Influenza-like Illness year round No Health Public Health Monitoring
none Influenza-like illness Reporting Yes Yes Fillable Printable Form Daily ILI Reporting Form.doc
State, Local, and Tribal Governments 27375 6844 0

CMRS Daily - City Health Officer or Vital Statistics Registrars No Health Public Health Monitoring
none CMRS Daily Yes Yes Fillable Fileable Form 122 CMRS daily mortality form.pdf
State, Local, and Tribal Governments 21170 4234 0

CMRS Weekly - City Health Officer or Vital Statistics Registrars No Health Public Health Monitoring
none CMRS Weekly Yes Yes Fillable Printable Form 122 CMRS weekly mortality form.pdf
State, Local, and Tribal Governments 6344 1269 0

Antiviral-Resistant Influenza infection Case Report Form No Health Immunization Management
none Antiviral-Resistant Influenza infection Case Report Form Yes Yes Fillable Fileable Form and instruction Antiviral Resistant Influenza Infection Case Report Form.pdf
State, Local, and Tribal Governments 171 86 0

NREVSS Laboratory Assessment No Health Public Health Monitoring
none Lab Assessment Yes No Printable Only Form NREVSS Laboratory Assessment FORM.docx
State, Local, and Tribal Governments 90 30 0

2014-01-10-05:00

0920-0006 201107-0920-006 0920
             
        "Application for Waiver of Inadmissibility Under Immigration and Nationality Act"
             
          
        
Section 212 (a) of the INA states that aliens with specific health-related grounds are ineligible to receive visas and ineligible for admission into the United States. However, section 212(g) of the INA authorizes the Attorney General to waive certain inadmissible health-related grounds which would allow an alien to overcome his/her inadmissibility. The Centers for Disease Control and Prevention (CDC) becomes involved in the waiver process as the recipient of a medical evaluation report, as indicated in the regulations (8 CFR 212.7): The previously approved data collection included information pertaining to application for HIV waiver applicants. On November 22, 2009, HHS/CDC published a final regulation [42 CFR Part 34] (Attachment -3) removing human immunodeficiency virus (HIV) as a communicable disease of public health significance. As a result of this rule change, aliens are no longer inadmissable based on HIV status and no longer require a waiver for admission. Therefore CDC form "CDC 4.422-1b" is no longer needed. 2014-09-30-04:00 Active Daniel Holcomb dwh6@cdc.gov 770 488-4472 No No No 400 100 16000

Application for Waiver of Inadmissibility Under Immigration and Nationality Act (Form 4-422-1) No Health Public Health Monitoring Private Sector 200 33 16000

Follow-up of Immigrants or Refugees with Class A Physical or Mental Condition No Health Public Health Monitoring Private Sector 200 67 0

Follow-up of Immigrants or Refugees with Human Immunodeficiency Virus (HIV) Infection After Resettlement No Health Public Health Monitoring Private Sector 0 0 0

2011-09-05-04:00

0920-0008 201212-0920-002 0920
             
        "Emergency Epidemic Investigations"
             
          
        
CDC receives requests from state and local health departments for scientific, medical and technical assistance in the event of an epidemic or medical emergency. This clearance package enables CDC scientists a means to collect data in the field. 2014-07-31-04:00 Active Thelma Sims 4046394771 No No No 15100 3775 0

Emergency Epidemic Investigations No Health Public Health Monitoring Individuals or Households 15000 3750 0

EPI-AID Satisfaction Survey for Requesting Official No Health Public Health Monitoring State, Local, and Tribal Governments 100 25 0

2013-07-01-04:00

0920-0009 201401-0920-007 0920
             
        "National Disease Surveillance Program "
             
          
        
CDC requests streamlining the way the Legionellosis Case Report is received by having states that are interested extract data from their electronic system to send to CDC via secure FTP in a file format like Excel or Access. States will enter the information into their state electronic system, fill out a hard copy for CDC, then CDC will enter the inforamtion into the electronic system. 2016-04-30-04:00 Active Catina Conner 4046394775 No No No 530 140 0

Typhoid Fever Surveillance Report No Health Public Health Monitoring
No number Typhoid Fever Surveillance Yes Yes Fillable Printable Form Typhoid Fever.pdf
State, Local, and Tribal Governments 0 0 0

Viral Hepatitis Case Record No Health Public Health Monitoring
No number Hepatitis Case Record Yes Yes Fillable Printable Form hepatitis.doc
State, Local, and Tribal Governments 0 0 0

CJD No Health Public Health Monitoring
none assigned CJD Yes Yes Printable Only Form CJD.pdf
State, Local, and Tribal Governments 40 13 0

Cyclosporiasis No Health Public Health Monitoring
none assigned Cyclosporiasis Yes Yes Printable Only Form Cyclosurvform2002.doc
State, Local, and Tribal Governments 0 0 0

Dengue Case Investigation No Health Public Health Monitoring
none assigned Dengue-Spanish Yes Yes Printable Only Form Dengue Case Investigation Report Spa.pdf none assigned Dengue Yes Yes Printable Only Form DEN CASE Form Eng 2004.pdf
State, Local, and Tribal Governments 0 0 0

Hantavirus Pulmonary Syndrome No Health Public Health Monitoring
none assigned Hantavirus Yes Yes Printable Only Form HPS_CaseReportForm2005.doc
State, Local, and Tribal Governments 0 0 0

Kawasaki Syndrome No Health Public Health Monitoring
none assigned Kawasaki Yes Yes Printable Only Form KSform-print_rev.pdf
State, Local, and Tribal Governments 440 110 0

Legionellosis Case Report No Health Public Health Monitoring
CDC 52.56 Legionellosis Case Report Yes Yes Printable Only Form Attach D 6 Legionella.pdf
State, Local, and Tribal Governments 0 0 0

Lyme Disease Report No Health Public Health Monitoring
none assigned Lyme Disease Yes Yes Printable Only Form Lyme5260.pdf
State, Local, and Tribal Governments 0 0 0

Malaria Case Surveillance Report No Health Public Health Monitoring
CDC 54.1 Malaria Case Surveillance Report Yes Yes Fillable Printable Form ProposedCDC Malaria Form_Oct132009.doc
State, Local, and Tribal Governments 0 0 0

Plaque Case Investigation Report No Health Public Health Monitoring
none assigned Plague Yes Yes Printable Only Form Plague.pdf
State, Local, and Tribal Governments 0 0 0

Q Fever No Health Public Health Monitoring
none assigned Q Fever Yes Yes Printable Only Form QFevercase_Rep_Fm.pdf
State, Local, and Tribal Governments 0 0 0

Reye Syndrome Case Surveillance Report No Health Immunization Management
none assigned Reye Syndrome Yes Yes Printable Only Form RS surveillance form.pdf
State, Local, and Tribal Governments 50 17 0

Tick-borne Rickettsial Disease Case Report No Health Public Health Monitoring
none assigned Tick-Borne Yes Yes Printable Only Form Tickborne case_Rep_Fm.pdf
State, Local, and Tribal Governments 0 0 0

Trichinosis Surveillance Case Report No Health Public Health Monitoring
none assigned Trichinosis Yes Yes Printable Only Form trichsurvform.doc
State, Local, and Tribal Governments 0 0 0

Tularemia No Health Public Health Monitoring
none assigned Tularemia Yes Yes Printable Only Form Tularemia.pdf
State, Local, and Tribal Governments 0 0 0

Leptospirosis Case Report No Health Immunization Management
none Leptospirosis Case Report Yes Yes Fillable Fileable Form Lepto_CRF_May2013.pdf
State, Local, and Tribal Governments 0 0 0

2014-01-30-05:00

0920-0010 201312-0920-002 0920
             
        "Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS)"
             
          
        
BD-STEPS is a case-control study similiar to the National Birth Defects Prevention Study that stopped interviewing participants in 2013. As in NBDPS, control infants are randomly selected from birth certificates or birth hospital records; mothers of case and control infants are interviewed using CATI. Parents are asked to collect DNA samples from themselves and their infants. 2017-01-31-05:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 7700 2888 0

Mother Questionnaire No Health Consumer Health and Safety
none BD-STEPS Yes Yes Fillable Fileable Form AttG_BDSTEPS_CATI_FullDraft_Nov8.docx
Individuals or Households 1925 1444 0

Biologic Specimen Collection No Health Consumer Health and Safety
none Consent Yes No Paper Only Form AttL_SalConsentFrm_Nov8.docx No No Paper Only Instruction AttQ_SalivaInstructionsParent_Oct23.docx No No Paper Only Instruction AttR_SalivaInstructionsChild_Nov5.docx
Individuals or Households 5775 1444 0

2014-01-02-05:00

0920-0017 201303-0920-009 0920
             
        "Application for Training"
             
          
        
CDC/OSELS offers public health training activities to professionals in the U.S. and worldwide. Employees of hospitals, universities, medical centers, laboratories, state and federal agencies, and state and local health departments apply for training to learn up-to-date public health practices. Training activites include laboratory training, classroom study, online training, and distance learning. CDC/OSELS uses two training application forms, the Training and Continuing Education Online New Participant Registration Form and the National Laboratory Training Network Registration Form, to collect informaton necessary to manage and conduct training pertinent to the agency's mission. Keywords: training, continuing education, laboratory training. 2016-05-31-04:00 Active Thelma Sims 4046394771 No No No 81500 6792 0

Application for Training - National Laboratory Training Network Registration form No Health Public Health Monitoring Individuals or Households 6500 542 0

Application for Training - CDC Training and Continuing Education New Participant Regstration Form (36.5) - Nurses No Health Public Health Monitoring Individuals or Households 0 0 0

Application for Training - CDC Training and Continuing Education New Participant Registration Form 36.5 No Health Public Health Monitoring Individuals or Households 75000 6250 0

Participant Information Form No Health Public Health Monitoring
none Participant Information Form Yes No Paper Only Form Proposed PIF Form 2011 OMB.docx
Individuals or Households 0 0 0

2013-05-13-04:00

0920-0020 201306-0920-003 0920
             
        "National Coal Workers' X-ray Surveillance Program (CWXSP) - Federal Mine Safety and Health Act 1977 (42CFR37)"
             
          
        
This submission will incorporate the National Coal Workers' X-Ray Surveillance Program 42 CFR 37 (0920-0020) and National Coal Workers' Autopsy Study 42 CFR Part 37.204 (0920-0021) into one complete package which will be called the Coal Workers' Health Surveillance Program (CWHSP). The expiration date for 0920-0020 is 4/30/2011. Upon OMB approval, 0920-0021 will be discontinued (expiration date, 1/31/2013). CWHSP is a congressionally-mandated medical examination program for monitoring the health of underground coal miners, established under the Federal Coal Mine Health and Safety Act of 1969, as amended in 1977 and 2006, PL-95-164 (the Act). The Act provides the regulatory authority for the administration of the CWHSP. This Program, which includes both a health surveillance and an autopsy component, has been useful in providing tools for protecting the health of miners (whose participation is entirely voluntary), and also in documenting trends and patterns in the prevalence of coal workers' pneumoconiosis ('black lung' disease) among miners employed in U.S. coal mines. During the early 1970s, one out of every three miners examined through the CWHSP who had worked at least 25 years underground had evidence of pneumoconiosis on their chest x-ray. An analysis among over 25,000 miners who participated in the x-ray Programs from 1996 to 2002 indicated that the proportion of affected individuals had decreased to about one in 20. However, recent surveillance analyses and research studies have confirmed that the prevalence of 'black lung' disease is increasing, there is regional clustering of rapidly progressive pneumoconiosis cases, and coal miners have a higher risk of disease if they perform certain jobs, work in smaller mines, or are from certain geographic areas. Importantly, young coal miners are developing the disabling and lethal forms of 'black lung'. 2014-06-30-04:00 Active Carol Walker 4046394773 No No No 23250 4471 0

Roentgenographic Interpretation No Health Illness Prevention
Form No 2.8 rointgenographic interpretation form Yes Yes Printable Only Form and instruction CWHSP-ReadingForm-2 8-new with defs.pdf
Private Sector 10000 500 0

Miner Identification Document No Health Illness Prevention
CDC/NIOSH (M) 2.9 Miner Identification Document No No Paper Only Form and instruction Form 2.9.pdf
Individuals or Households 5000 1667 0

Coal Mine Operator's Plan No Health Illness Prevention
CDC/NIOSH (M) 2.10 Coal Mine Operator's Plan No No Paper Only Form and instruction Form 210.pdf CDC/NIOSH (M) 2.9 Miner Identification Document No No Paper Only Form and instruction Form 2.9.pdf
Private Sector 200 100 0

Facility Certification Document No Health Illness Prevention
4 Facility Certification Document No No Paper Only Form Attmt 7- CWHSP-Facility-2.11v2010.pdf CDC/NIOSH (M) 2.11 Facility Certification Document No No Paper Only Form and instruction Form 211.pdf CDC/NIOSH (M) 2.10 Coal Mine Operator's Plan No No Paper Only Form and instruction Form 210.pdf CDC/NIOSH (M) 2.9 Miner Identification Document No No Paper Only Form and instruction Form 2.9.pdf
Individuals or Households 100 50 0

Interpretating Physician Certification Document No Health Illness Prevention
CDC/NIOSH (M) 2.11 Facility Certification Document No No Paper Only Form and instruction Form 211.pdf CDC/NIOSH (M) 2.12 Facility Certification Document No No Paper Only Form and instruction Form 212.pdf CDC/NIOSH (M) 2.10 Coal Mine Operator's Plan No No Paper Only Form and instruction Form 210.pdf CDC/NIOSH (M) 2.9 Miner Identification Document No No Paper Only Form and instruction Form 2.9.pdf
Private Sector 300 50 0

Coal Workers' Health Surveillance Program (CWHSP)-Consent Release and History Form- Next of Kin (form 2.6) No Health Immunization Management
5 Coal Workers' Health Surveillance Program (CWHSP)-Consent Release and History Form- Next of Kim (form 2.6) No No Paper Only Form Attmt 9- CDC NIOSH 2.6 NCWAS Consent Release History Form 4.18.11.doc
Individuals or Households 50 13 0

Coal Workers' Health Surveillance Program (CWHSP)- Invoice-Pathologist No Health Immunization Management
6 Coal Workers' Health Surveillance Program (CWHSP)- Invoice-Pathologist No No Paper Only Form Attmt 10- Pathologist Invoice Sample.pdf 5 Coal Workers' Health Surveillance Program (CWHSP)-Consent Release and History Form- Next of Kim (form 2.6) No No Paper Only Form Attmt 9- CDC NIOSH 2.6 NCWAS Consent Release History Form 4.18.11.doc
Individuals or Households 50 4 0

Coal Workers' Health Surveillance Program (CWHSP)- Report Pathologist No Health Immunization Management
9 Coal Workers' Health Surveillance Program (CWHSP)- Report Pathologist No No Paper Only Form and instruction Attmt 11- NCWAS checklist 4.18.11 (2).doc 6 Coal Workers' Health Surveillance Program (CWHSP)- Invoice-Pathologist No No Paper Only Form Attmt 10- Pathologist Invoice Sample.pdf 5 Coal Workers' Health Surveillance Program (CWHSP)-Consent Release and History Form- Next of Kim (form 2.6) No No Paper Only Form Attmt 9- CDC NIOSH 2.6 NCWAS Consent Release History Form 4.18.11.doc
Individuals or Households 50 4 0

Coal Workers' Health Surveillance Program (CWHSP)-Spirometry Test No Health Immunization Management
none Spirometry Yes No Fillable Printable Form SPIROMETRY data collection.docx 9 Coal Workers' Health Surveillance Program (CWHSP)- Report Pathologist No No Paper Only Form and instruction Attmt 11- NCWAS checklist 4.18.11 (2).doc 6 Coal Workers' Health Surveillance Program (CWHSP)- Invoice-Pathologist No No Paper Only Form Attmt 10- Pathologist Invoice Sample.pdf 5 Coal Workers' Health Surveillance Program (CWHSP)-Consent Release and History Form- Next of Kim (form 2.6) No No Paper Only Form Attmt 9- CDC NIOSH 2.6 NCWAS Consent Release History Form 4.18.11.doc
Individuals or Households 2500 833 0

Coal Workers' Health Surveillance Program (CWHSP)-X-ray Coal Miners No Health Immunization Management
6 Coal Workers' Health Surveillance Program (CWHSP)- Invoice-Pathologist No No Paper Only Form Attmt 10- Pathologist Invoice Sample.pdf 5 Coal Workers' Health Surveillance Program (CWHSP)-Consent Release and History Form- Next of Kim (form 2.6) No No Paper Only Form Attmt 9- CDC NIOSH 2.6 NCWAS Consent Release History Form 4.18.11.doc 9 Coal Workers' Health Surveillance Program (CWHSP)- Report Pathologist No No Paper Only Form and instruction Attmt 11- NCWAS checklist 4.18.11 (2).doc
Individuals or Households 5000 1250 0

2013-06-11-04:00

0920-0026 201104-0920-010 0920
             
        "Report of Verified Case of Tuberculosis (RVCT)"
             
          
        
CDC is requesting OMB approval for 3-year extension of the data collection form called Report of Verified Case of Tuberculosis (RVCT) for the national tuberculosis (TB) surveillance system. The previously approved Information Collection Request is OMB No. 0920-0026. This request reflects extension without changes to the currently approved RVCT. Respondents to the collection remain as before, territorial, state, and local public health departments in 60 reporting areas (50 states, the District of Columbia, New York City, Puerto Rico, and 7 jurisdictions in the Pacific and Caribbean). National TB surveillance system data assist federal, state, and local public health officials and policy makers in program planning, evaluation, and resource allocation. CDC publishes summarized data on TB in the United States annually, which is disseminated to TB control officers, pulmonary and infectious disease experts, and others interested in TB control. 2014-05-31-04:00 Active Daniel Holcomb dwh6@cdc.gov 770 488-4472 No No No 11520 6720 0

Report of Verified Case of Tuberculosis (RVCT) No Health Public Health Monitoring
Attachment 3 72.9A CDC 72 9AB and C Yes Yes Fillable Printable Form and instruction 0920-0026 Attachment 3 CDC 72 9AB and C.pdf
State, Local, and Tribal Governments 11520 6720 0

2011-05-10-04:00

0920-0106 201307-0920-005 0920
             
        "Preventive Health and Health Services Block Grant"
             
          
        
CDC currently provides Block Grant funding to 61 states, territories and tribal organizations, and collections Work Plans and Annual Reports to monitor their progress toward meeting Healthy People objectives, and to provide technical assistance. CDC requests OMB approval to continue information collection for two years. Information will be collected using a web-based MIS. 2016-08-31-04:00 Active Thelma Sims 4046394771 No No No 122 2135 0

PHHS Block Grant Management Information System (BG-MIS) Work Plan No Health Public Health Monitoring State, Local, and Tribal Governments 61 1220 0

PHHS Block Grant Management Information System (BG-MIS) Annual Report No Health Public Health Monitoring State, Local, and Tribal Governments 61 915 0

2013-08-14-04:00

0920-0109 201105-0920-012 0920
             
        "Information Collection Provisions in 42 CFR Part 84 - Tests and Requirements for Certification and Approval of Respiratory Protective Devices"
             
          
        
Required Collection of Information on Respirators Approved under 42 CFR Part 84. These regulations mandate the performance tests and criteria for approval of respirators used by millions of American construction workers, miners, painters, asbestos removal workers, fabric mill workers, and fire fighters. In addition to benefiting industrial workers, the improved testing requirements also benefit health care workers implementing the CDC Guidelines for Preventing the Transmission of Tuberculosis. Regulations of the Environmental Protection Agency (EPA) and the Nuclear Regulatory Commission (NRC) also require the use of NIOSH-approved respirators. 2014-08-31-04:00 Active Daniel Holcomb dwh6@cdc.gov 770 488-4472 No No No 660 138840 0

Information Collection Provisions in 42 CFR Part 84 - (Standard Application fro the Approval of Resiporators) No Health Immunization Management
0920-0109 Standard Application for the Approval of Respirators (version 7) Yes Yes Printable Only Form and instruction Attachment C Standard Application for Resiporator approval.xps 0920-0109 Attachment E: Standard Application for Respirator Approvale (version 8) Yes Yes Fillable Printable Form and instruction Application Form (Version 8).xps
Private Sector 600 137400 0

Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) No Health Immunization Management Private Sector 60 1440 0

2011-08-11-04:00

0920-0128 201212-0920-005 0920
             
        "Congenital Syphilis Case Investigation and Report Form"
             
          
        
A reporting form for congenital syphilis (CDC Form 73.126) was initiated in 1983 to improve detection, case management, and treatment of congenital syphilis cases. The CDC continues to gather and report information on congenital syphilis morbidity as part of its ongoing Sexually Transmitted Disease (STD) surveillance efforts. This request includes numerous variable changes to collect pertinent data and enable appropriate classification of congenital syphilis cases. 2016-01-31-05:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 187 63 0

Congenital Syphilis (CS) Case Investigation and Report Form: Local Health Department No Health Public Health Monitoring
none Congenital Syphilis Case Investigation and Report Yes Yes Fillable Fileable Form Att3c Congenital Form.docx
State, Local, and Tribal Governments 110 37 0

Congenital Syphilis (CS) Case Investigation and Report Form Territorial Health Agencies No Health Health Care Services
none Congenital Syphilis Case Investigation and Report Yes Yes Fillable Fileable Form Att3c Congenital Form.docx
Federal Government 33 11 0

Congenital Syphilis (CS) Case Investigation and Report Form: City and county health departments No Health Public Health Monitoring
none Congenital Syphilis Case Investigation and Report Yes Yes Fillable Fileable Form Att3c Congenital Form.docx
State, Local, and Tribal Governments 44 15 0

2013-01-09-05:00

0920-0134 201305-0920-003 0920
             
        "Foreign Quarantine Regulations"
             
          
        
Section 361 of the Public Health Service Act (42 U.S.C. 264) authorizes the Secretary of Health and Human Services to make and enforce regulations necessary to prevent the introduction, transmission or spread of communicable diseases. This change request adds one cumulative reporting form and part of an approved form to simplify illness reporting. 2015-07-31-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 2740568 227263 0

71.21 (a) Radio Report of Death/Illness Report from Ships No Health Immunization Management
none Maritime Conveyance Cumulative Influenza-Like Illness Form Yes Yes Fillable Fileable Form Attachment A Maritime Cumulative ILI Form.pdf none Maritime Conveyance Illness or Death Investigation Form Yes Yes Fillable Fileable Form Attachment B Maritime investigation form_June22 2012.docx
Private Sector 2000 67 0

71.33(c) Report by person in isolation or surveillance No Health Public Health Monitoring Private Sector 11 1 0

71.35 Report of death/illness in port No Health Public Health Monitoring Private Sector 5 3 0

Public Health Passenger Locator Form - Outbreak Aircraft No Health Immunization Management
4 Public Health Passenger Locator Form No No Paper Only Form and instruction Attachment 4 Passenger Locator Form 2012.pdf
Private Sector 2700000 225000 0

Locator Form used for Reporting of an Ill Passenger(s) (Airport) No Health Public Health Monitoring
4 Public Health Passenger Locator Form No No Fillable Fileable Form Attachment 4 Passenger Locator Form 2012.pdf
Private Sector 800 67 0

Dogs/Cats: Record of Sickness or Deaths 71.51 (b)(3) No Health Immunization Management Private Sector 20 5 0

Dogs/Cats: Certification of confinement, vaccination, CDC form 75.37. Title 71.51(b) No Health Immunization Management
5 Notice to Owners and Importers of Dogs No No Paper Only Form and instruction Attachment 7 CDC form 75 37 NOTICE TO OWNERS AND IMPORTERS OF DOGS Requirement for Dog Confinement.pdf
Private Sector 2000 333 0

71.52 Turtle Importation Permits No Health Immunization Management Private Sector 5 3 0

Death/Illness Reports from Aircraft Title 71.21 (b) No Health Immunization Management Private Sector 1700 57 0

Gastrointestinal Illness Reports 24 and 4 hours before Arrival (VSP) Title 71.21. (c) No Health Immunization Management
2 Maritime Illness and Death Reporting System--Gastrointestinal Illness Report Yes No Fillable Fileable Form Attachment 6a 71.21c Gastrointestinal illnesses reports MIDRS screenshot.pdf
Private Sector 17000 850 0

Recordkeeping--Medical Logs (Maritime), Title 71.21 (c) No Health Immunization Management
2 Maritime Illness and Death Reporting System--Gastrointestinal Illness Report Yes No Fillable Fileable Form Attachment 6a 71.21c Gastrointestinal illnesses reports MIDRS screenshot.pdf
Private Sector 17000 850 0

African Rodents--Request for Exemption Title 71.56 (a)(2) No Health Immunization Management Private Sector 20 20 0

Dead Bodies--Death Certificates Title 71.55 No Health Immunization Management Private Sector 5 5 0

Appeal (Importer) Title 71.56 (a)(iii) No Health Immunization Management Private Sector 2 2 0

2013-05-13-04:00

0920-0138 201107-0920-003 0920
             
        "Pulmonary Function Testing Course Approval Program, 29 CFR 1910.1043"
             
          
        
NIOSH maintains a Pulmonary Function Testing Course Approval Program. The program consists of an application submitted by potential sponsors (universities, hospitals, and private consulting firms) who seek NIOSH approval to conduct courses, and if approved, notification to NIOSH of any course or faculty changes during the approval period, which is limited to five years. Submissions are required for NIOSH to evaluate a course and determine whether it meets the criteria in the Standard and whether technicians will be adequately trained as mandated under the Standard. The estimated annual burden to respondents is 196 hours. 2014-08-31-04:00 Active Petunia Gissendaner 4046390164 No No No 73 196 0

Pulmonary Function Testing Course Approval Program Annual Report No Health Illness Prevention
1 Annual Report Yes Yes Fillable Fileable Form and instruction Attachment D Annual Report a.doc
Private Sector 35 18 0

Renewal Application No Health Illness Prevention
2 NIOSH -Approved Spirometry Course Sponsorship Renewal Application Yes Yes Fillable Fileable Form and instruction Attachment E NIOSH-Approved Spirometry Course Sponsorship Renewal Application a.doc
Private Sector 13 78 0

Initial Application No Health Illness Prevention
3 NIOSH-Approved Spirometry Testing Course Application Yes Yes Fillable Fileable Form and instruction Attachment C NIOSH-Approved Spirometry Testing Course Application a.doc
Private Sector 3 11 0

Refresher Course Application No Health Illness Prevention
4 NIOSH-Approved Spirometry Refresher Course Application Yes Yes Fillable Fileable Form and instruction Attachment F NIOSH-Approved Spirometry Refresher Course Application a (2).doc
Private Sector 10 80 0

Request for Course Change Sample No Health Illness Prevention Private Sector 12 9 0

2011-08-08-04:00

0920-0199 201312-0920-005 0920
             
        "Import Permit Applications (42 CFR 71.54)"
             
          
        
The Application for Permit to Import Biological Agents and Vectors of Human Disease into the US form is used by laboratory facilities, such as those operated by government agencies, universities, and research institutions to request a permit for the importation of biological agents, infectious substances, or vectors of human disease. The form requests applicant and sender contact information; description of material for importation; facility isolation and containment information; and personnel qualifications. 2017-01-31-05:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 1635 545 0

Importation of Infectious Biological Agents, Infectious Substances, and Vectors into the US No Health Immunization Management
none Application for Permit to Import Biological Agents or Vectors of Human Disease into the US Yes Yes Fillable Fileable Form Attachment 8-Application For Permit To Import Infectious Biological Agents Into The United States_clean version - Copy.doc
Private Sector 1625 542 0

Application for Permit to Import or Transport Live Bats (71.54) No Health Public Health Monitoring
none Application for Permit to Import or Transfer Live Bats Yes Yes Fillable Fileable Form Attachment 9-Application for Permit to Import or Transport Live Bats_clean version.doc
Private Sector 10 3 0

2014-01-23-05:00

0920-0210 201301-0920-003 0920
             
        "List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products"
             
          
        
This is a legislatively mandated information collection. Since 1986, as required by the Comprehensive Smoking Education Act of 1984 (CSEA, 15 U.S.C. 1336 or P.L. 98-474) CDC's Office on Smoking and Health has collected information from cigarette manufacturers, packagers and importers about the ingredients used in cigarette products. This collection is commonly known as the Ingredient Report. 2014-02-28-05:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 77 501 0

Ingredient Report No Health Illness Prevention Private Sector 77 501 0

2013-02-04-05:00

0920-0212 201302-0920-001 0920
             
        "National Hospital Care Survey"
             
          
        
NCHS requests approval to continue the NHCS and to begin to integrate the NHAMCS into NHCS as part of a broader strategy to improve efficiency by minimizing redundancy in data collection, broadening capability to collect more relevant data on transitions in care, and identifying opportunities to exploit administrative and electronic clinical data systems. NHCS will electronically collect administrative claims data, but as hospitals adopt EHRs, it will be poised to accept electronic files. In 2013 NHAMCS will operate in tandem with the ambulatory component of NHCS so data from the two surveys can be compared. 2016-04-30-04:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No Yes No 131516 7224 0

Initial Hospital Intake Questionnaire No Health Immunization Management
none Initial Hospital Intake Yes Yes Fillable Fileable Form Attachment I- Initial Intake Questionnaire.docx
Private Sector 133 133 0

Recruitment Survey Presentation No Health Immunization Management
none Recruitment Survey Presentation No No Printable Only Form Attachment J- Survey Presentation for NHCS.docx
Private Sector 133 133 0

Annual Inpatient Hospital Interview No Health Immunization Management
none Annual Inpatient Hospital Interview No No Printable Only Form Attachment K- Annual Inpatient Hospital Interview.docx
Private Sector 500 500 0

Annual Ambulatory Hospital Interview No Health Immunization Management
none Annual Ambulatory Hospital Interview Yes Yes Fillable Fileable Form Attachment L - Annual Ambulatory Hospital Interview.docx none Annual Ambulatory Hospital Interview Yes Yes Fillable Fileable Form
Private Sector 500 750 0

Ambulatory Unit Induction No Health Immunization Management
none Ambulatory Unit Induction Yes Yes Fillable Fileable Form Attachment M - Ambulatory Unit Induction.docx
Private Sector 2000 500 0

Prepare and transmit UB-04 for Inpatient and Ambulatory No Health Public Health Monitoring
none Quarterly Transmission of UB-04 Data Yes Yes Fillable Fileable Form NHCS 2013 Attac N- Quarterly Data Transmission 011613.doc
Private Sector 2000 2000 0

Pulling and re-filing Patient Records (ED, OPD, and ASL) No Health Immunization Management Private Sector 112500 1875 0

Annual FSASC Interview No Health Immunization Management
none Annual FSASC Interview Yes Yes Fillable Fileable Form Attachment P- FSASC Induction Form.docx
Private Sector 250 125 0

FSASC Prepare and Transmit UB-40 No Health Immunization Management Private Sector 1000 1000 0

FSASC Pulling and Refiling Patient Records No Health Immunization Management Private Sector 12500 208 0

2013-04-15-04:00

0920-0213 201202-0920-009 0920
             
        "NCHS: National Vital Statistics Report Forms"
             
          
        
This Project is the collection of monthly and annual counts of Vital Statistics data from states (and in some instances other jurisdictions). These data are widely used by the health and behavioral science communities in surveillance and in tracking trends, by the private sector, and by academia for health and demographic research. State and national data are required by the Census Bureau to prepare annual population estimates and projections. 2015-04-30-04:00 Active Petunia Gissendaner 4046390164 No No No 1150 211 0

National Vital Statistics Report Forms -- line 1 -- Monthly Vital Statistics Report No Health Public Health Monitoring
1 Monthly Vital Statistics Report Yes Yes Fillable Printable Form NVSR 2012-2015 Att B Monthly Form 120111.doc
State, Local, and Tribal Governments 1092 182 0

National Vital Statistics Report Form -- line 2-- Annual Vital Statistics Occurence Report No Health Public Health Monitoring
Yes Yes Fillable Printable Other NVSReport_Att_D_Annual_Form_032609.doc 2 Annual Vital Statistics Occurence Report Yes Yes Fillable Printable Form NVSR 2012-2015 AttD Annua Form120111.doc
State, Local, and Tribal Governments 58 29 0

2012-04-02-04:00

0920-0214 201312-0920-006 0920
             
        "National Health Interview Survey "
             
          
        
CDC is requesting revision to the annual National Health Interview Survey (NHIS). NHIS is a major source of general statistics on the health of the U.S. population and has been in the field every year since 1957. This household-based survey collects demographic and health-related information on a nationally representative sample of households throughout the country. This revision seeks approval to continue the NHIS for 2014-2016, to cycle in questions on various topics including heart disease and stroke, arthritis, hearing, food security, immunization, tobacco use, questions to measure the impact of the Affordable Care Act, child mental health, functioning and disability, hepatitis screening, and sexual identity, continue the increase in sample size funded under the Patient Protection and Affordable Care Act, In 2014 we will introduce a Native Hawaiian and Pacific Islander NHIS and conduct a web-based mult-imode follow-back survey of sample adult respondents from an earlier NHIS. The survey will focus on adult health, health care access and use, and health insurance coverage. Permission to conduct a test of incentive use with the NHIS is also sought. 2016-12-31-05:00 Active Carol Marsh cww6@cdc.gov 404 639-4773 No Yes No 179000 45500 0

Screener Questionnaire No Health Immunization Management
none Screener Yes Yes Fillable Fileable Form Attachment 3 - OMB Statement and Screener.pdf
Individuals or Households 10000 833 0

Family Core (adult family member) No Health Immunization Management Individuals or Households 45000 17250 0

Adult Core (sample adult) No Health Immunization Management Individuals or Households 36000 9000 0

Child Core (adult family member) No Health Immunization Management Individuals or Households 14000 2333 0

Child / Teen Record Check (medical provider) No Health Immunization Management
none Child/Teen Yes Yes Fillable Fileable Form Attachment 3d Child-Teen Record Check.pdf
Individuals or Households 8000 667 0

Supplements (adult family member) No Health Immunization Management
none Supplements Yes Yes Fillable Fileable Form Attachment 3e - 2014 Supplements and New Core Questions.pdf
Individuals or Households 45000 9000 0

Sexual Identity Module--Line 7 No Health Immunization Management
none Sexual Identity Module Yes Yes Fillable Fileable Form Attachment 3f Sexual Identity Module (4 minutes).docx.docx
Individuals or Households 0 0 0

NHCIS Multi-mode Study (adult family member) No Health Immunization Management
none NHCIS Yes Yes Fillable Fileable Form Attachment 3f NHCIS Multi-Mode Study.pdf
Individuals or Households 12000 2000 0

Native Hawaiian / Pacific Islander Survey (adult family member) No Health Immunization Management
none Native Hawaiian Pacific Islander Yes Yes Fillable Fileable Form Native Hawaiian Pacific Islander.docx
Individuals or Households 4000 4000 0

Reinterview Survey No Health Immunization Management
none Reinterview Yes Yes Fillable Fileable Form Attachment 3g - Reinterview Survey.pdf
Individuals or Households 5000 417 0

2014-01-11-05:00

0920-0215 201309-0920-006 0920
             
        "Application Form and Related Forms for the Operation of the National Death Index"
             
          
        
CDC requests to extend data collection. Researchers apply to use the National Death Index (NDI) to determine whether persons in their studies have died and to obtain information on the decedents' states, dates of death, death certificate numbers, and causes of death. The administrative forms are completed by researchers in order to apply for NDI services and to submit their study subjects' records for computer matching against the NDI file. 2016-10-31-04:00 Active Keith Tucker keith.tucker@hhs.gov 202 260-5965 No No No 240 182 0

National Death Index - Application Form No Health Public Health Monitoring
0920-0215 National Death Index Application Form Yes Yes Fillable Printable Form NDI NEW Att B appl.doc
State, Local, and Tribal Governments 50 125 0

National Death Index- Request for Repeat Application Form No Health Public Health Monitoring
0920-0215 Repeat Request for Application Form none Yes Yes Fillable Printable Form NDI NEW Att C repeat.pdf
State, Local, and Tribal Governments 70 21 0

National Death Index - Transmittal Form No Health Public Health Monitoring
0920-0215 Transmittal Form none Yes Yes Fillable Printable Form NDI NEW Att D Trans.pdf
State, Local, and Tribal Governments 120 36 0

2013-10-28-04:00

0920-0217 201303-0920-014 0920
             
        "NCHS Application for Vital Statistics Training Form"
             
          
        
CDC/NCHS provides free training courses to state, county, and local vital records and vital statistics staff as part of a program to promote uniformity and high quality of national vital statistics data. Clearance is sought for 2 forms for individuals to apply for such training from NCHS. 2016-05-31-04:00 Active Thelma Sims 4046394771 No No No 120 30 0

Application for Training No Health Public Health Monitoring State, Local, and Tribal Governments 60 15 0

Annual Survey of Training Needs No Health Public Health Monitoring State, Local, and Tribal Governments 60 15 0

2013-05-02-04:00

0920-0222 201205-0920-001 0920
             
        "NCHS Questionnaire Design Research Laboratory"
             
          
        
This submission describes proposed research activities of the National Center for Health Statistics (NCHS) Questionnaire Design Research Laboratory. Survey specific research activities include questionnaire development, pre-testing, and evaluation activities for NCHS, CDC, other federal agencies, or other academic or professional institutions. The purpose and use of collecting this information fall into five categories: 1) Development and testing of specific survey questionnaires; 2) Research on the cognitive and interpretive aspects of survey methodology; 3) Research on human-computer interfaces/usability; 4) Field tests/Pilot interviewing; and 5) Studies of the optimal design and presentation of statistical graphical and textual material. Methods for data collection include interviewer administered, self-administered, telephone, Computer Assisted Personal Interviewing (CAPI) and Computer Assisted Self-Interviewing (CASI), Audio Computer-Assisted Self-Interviewing (ACASI), and web-based questionnaires including: cognitive interviewing, focus groups, usability testing, and field tests/pilot household interviews. 2015-06-30-04:00 Active Petunia Gissendaner 4046390164 No No No 9300 9450 0

Questionnaire Design Research Lab: 5600 Case CAPI and ACASI NHIS Field Test No Health Immunization Management
none Proposed ACASI Questions Yes Yes Fillable Fileable Form and instruction QDRL NHIS 5600 Attach 1- 05172012.docx none HIS-100C, January 2011 Manual for NHIS Field Reps Explaning the Survey Yes Yes Fillable Fileable Form and instruction QDRL NHIS 5600 Attach 2 - 0213 2012.docx
Individuals or Households 5600 5600 0

Violence Against Children Survey Evaluation Study - Philippines No Health Immunization Management
none Violence Against Children Survey Yes No Fillable Printable Form QDRL VACS Attach 1 - Qnne final 0710 2012.docx
Individuals or Households 40 80 0

4 Sets of Health Questions and Blood Donor History Questionnaire Evaluation No Health Immunization Management
none Four Sets of Health Related Questions Yes Yes Fillable Fileable Form and instruction QDRL 4 sets of health related Qs - Attachment 1-0731 2012.docx none Blood Donor History Questionnaire Yes Yes Fillable Fileable Form and instruction QDRL OASH Blood Donor Attach 2-0731 2012.doc
Individuals or Households 125 125 0

Evaluation of Uniform Donor History Questionnaire and Evaluation of Violence Against Children Survey (VACS)- Malawi No Health Immunization Management
None Attachment 1: Violence Against Children Survey - Malawi: Age 13-24 years Yes Yes Fillable Fileable Form QDRL VACS Malawi Attach 1 - Qnne.docx None What to do when a loved one dies-A survivor's checklist Yes Yes Fillable Fileable Form Attach 3c - Survivor's Checklist.pdf None Attachment 1 Uniform Donor History Questionnaire Yes Yes Fillable Fileable Form and instruction Attach 1 - Uniform Donor Qnne.docx
Individuals or Households 65 75 0

Testing Long-term Care Questions No Health Immunization Management
none NSLTP - Residential Care Community Yes Yes Fillable Fileable Form QDRL OMB-10-day letter LTC Attt 1a - LTC RCC Questionaire 061113.docx none NSLTP - Adult Day Services Center Yes Yes Fillable Fileable Form QDRL OMB-10-day letter LTC Att 1b - LTC RCC Questionaire 061113.docx none Screeners Yes Yes Fillable Fileable Form and instruction QDRL OMB-10-day package LTC Att 3ab - LTC Telephone Screener 06102013.docx
Private Sector 26 26 0

GENERIC IC Gen IC Questionnaire Design Research Lab - 2013 Comparative Disability Questions and Mode Effects Study No Health Immunization Management
None Attachment 1b: Washington Group Questionnaire Yes Yes Fillable Fileable Form QDRL Att 1b_CDME Washington Grp Quest.docx None Attachment 1a: WHO Questionnaire Yes Yes Fillable Fileable Form QDRL Att 1a - CDME WHO Questionnaire.docx None Attachments 3a & 3b--Telephone Screeners Yes Yes Fillable Fileable Form and instruction Att 3a, &b - CDME Tel Scrns 0711 2013.docx
Private Sector 120 180 0

2013 NHIS Health Insurance Web and Cognitive Interview Study No Health Immunization Management
4 Questionnaire Yes Yes Fillable Fileable Form and instruction Attachment 4 - Screen Shots of the Revised HE Web Questionnaire.docx none Screener Yes No Fillable Fileable Form and instruction Attachment 3a, &b - HE Cog Int Telephone Screeners.docx No No Printable Only Instruction Attachment 1b - HE Cog Interview Guide.docx
Individuals or Households 1550 300 0

Adult and Child Disability Questions No Health Immunization Management
none Screening Script No No Fillable Printable Form and instruction 0920-0222 Attach 3 - Screening script 0106 2014.docx none Child Disability Questions No No Fillable Printable Form 0920-0222 Attachment 1b - Child Disability Questions 0106 2014.docx none Adult Disability Questions No No Fillable Printable Form 0920-0222 Attachment 1a - Adult Disability Questions 0106 2014.doc
Individuals or Households 100 100 0

2012-06-13-04:00

0920-0234 201309-0920-004 0920
             
        "National Ambulatory Medical Care Survey"
             
          
        
This request is for a nonsubstantive change to modify selected sections of the 2012-2014 National Ambulatory Medical Care Survey to colelct new and/or updated information. Minor changes have been made to two survey insturments, and one module (the lookback) was removed. 2014-12-31-05:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 Yes Yes No 553650 47943 0

NAMCS-1 Physician Induction Interview (Line 1) No Health Immunization Management
none NAMCS-1 Induction Interview Yes Yes Fillable Fileable Form Attachment C1.pdf
Private Sector 17034 9937 0

NAMCS-201 Community Health Center Induction Interview (Line 2) No Health Immunization Management
none Att K - Community Health Center Induction Interview Yes Yes Fillable Fileable Form Att K Community Health Center Induction Interview 2011.pdf
Private Sector 2008 669 0

NAMCS-30 Patient Record form (Line 3) No Health Immunization Management
none Patient Record Form Yes Yes Fillable Fileable Form NAMCS 2014 Attachment D 082713.docx
Private Sector 102210 23849 0

Pulling and re-filing Patient Record form (Line 4) No Health Immunization Management Private Sector 408810 6814 0

Lookback Module (Line 5) No Health Immunization Management
None National Ambulatory Medical Care Survey 2013 Look Back Module Yes Yes Fillable Fileable Form Attachment C.pdf
Private Sector 0 0 0

2012 Asthma Supplement (line 6) No Health Immunization Management
none Att B - Asthma Supplement Yes Yes Fillable Fileable Form Att B Asthma Supplement.pdf
Private Sector 11072 3691 0

National Electronic Health Records Survey (line 7) No Health Immunization Management
None National Electronic Health Records Survey 2013 Yes Yes Fillable Fileable Form Attachment D.docx
Private Sector 4344 1448 0

Physician Workflow Survey (line 8) No Health Immunization Management
None E. Physician Workflow Survey Year 2013 (EHR adopters) Yes No Fillable Printable Form Attachment E.docx None F. Physician Workflow Survey Year 2013 (EHR nonadopters) Yes No Fillable Printable Form Attachment F.docx
Private Sector 2645 1323 0

2012 CPT Pretest NAMCS-1 (line 9) No Health Immunization Management
none Att Z - NAMCS 2011 Panel CPT Code Pretest Yes Yes Fillable Fileable Form Att z 2011 namcs-1 - pretest.pdf
Private Sector 17 10 0

2012 Pretest NAMCS Patient Record Form (line 10) No Health Immunization Management
none Att BB - NAMCS 2012 - Patient Record Form CPT Code Pretest Yes Yes Fillable Fileable Form Att BB NAMCS Patient Record form (NAMCS-30)-CPT Code PRETEST.pdf
Private Sector 510 119 0

Re-abstraction Study No Health Immunization Management Private Sector 5000 83 0

2013-11-04-05:00

0920-0255 201311-0920-017 0920
             
        "Resources and Services Database of the National Prevention Information Network"
             
          
        
The National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) requests a 3-year approval for revisions to the previously approved information collection entitled, "Resources and Services Database of the National Prevention Information Network", (formerly known as the National AIDS Clearinghouse) of the Centers for Disease Control and Prevention (CDC) (OMB Control No. 0920-0255).This information collection expires on January 31, 2014. 2016-12-31-05:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 11700 1932 0

Resources and Services Database of the CDC National Prevention Information Network - Initial Questionnaire Telephone Script: Registered Nurses No Health Health Care Services
0920-0255 Att3A_Initial_Res_Org_Quest Yes Yes Fillable Fileable Form and instruction Att3A_Initial_Res_Org_Quest.docx 0920-0255 Att3B_initial_quest_tele_scriptClean Yes Yes Fillable Fileable Form and instruction Att3B_initial_quest_tele_scriptClean.docx
Private Sector 100 33 0

Resources and Services Database of the CDC National Prevention Information Network - Initial Questionnaire Telephone Script: Health Educators No Health Health Care Services
0920-0255 Att3B_initial_quest_tele_scriptClean Yes Yes Fillable Fileable Form and instruction Att3B_initial_quest_tele_scriptClean.docx 0920-0255 Att3A_Initial_Res_Org_Quest Yes Yes Fillable Fileable Form and instruction Att3A_Initial_Res_Org_Quest.docx
Private Sector 50 11 0

Resources and Services Database of the CDC National Prevention Information Network - Initial Questionnaire Telephone Script: Social and Community Service Managers No Health Health Care Services
0920-0255 Att3A_Initial_Res_Org_Quest Yes Yes Fillable Printable Form and instruction Att3A_Initial_Res_Org_Quest.docx 0920-0255 Att3B_initial_quest_tele_scriptClean Yes Yes Fillable Fileable Form and instruction Att3B_initial_quest_tele_scriptClean.docx None Appendix E: Annual update request (Telephone) No No Fillable Fileable Form and instruction Annual update Request (Telephone.doc
Private Sector 50 8 0

Resources and Services Database of the CDC National Prevention Information Network - Initial Questionnaire Telephone Script: Social and Human Service Assistants No Health Health Care Services
0920-0255 Att3B_initial_quest_tele_scriptClean Yes Yes Fillable Printable Form and instruction Att3B_initial_quest_tele_scriptClean.docx 0920-0255 Att3A_Initial_Res_Org_Quest Yes Yes Fillable Printable Form and instruction Att3A_Initial_Res_Org_Quest.docx None Appendix F: Annual update Request (E-Mail) Yes Yes Fillable Fileable Form and instruction Annual update Request (E-Mail).doc
Private Sector 400 100 0

Resources and Services Database of the CDC National Prevention Information Network - Telephone Verification: Registered Nurses, Social and Community Service Managers, and Health Educators No Health Health Care Services
0920-0255 Att3C_tele_verification_script Yes Yes Fillable Fileable Form and instruction Att3C_tele_verification_script.docx
State, Local, and Tribal Governments 2400 400 0

Resources and Services Database of the CDC National Prevention Information Network - Telephone Verification: Social and Community Service Managers No Health Health Care Services
3 Telephone Verification Script Yes Yes Fillable Fileable Form Final_0920_0255_att3-C_tele_verification_script_rev.docx
State, Local, and Tribal Governments 0 0 0

Resources and Services Database of the CDC National Prevention Information Network - Telephone Verification: Health Educators No Health Health Care Services
3 Telephone Verification Sript Yes Yes Fillable Printable Form Final_0920_0255_att3-C_tele_verification_script_rev.docx
State, Local, and Tribal Governments 0 0 0

Social and Human Service Assistants No Health Health Care Services
0920-0255 Att3C_tele_verification_script Yes Yes Fillable Fileable Form and instruction Att3C_tele_verification_script.docx
Federal Government 4800 720 0

Resources and Services Database of the CDC National Prevention Information Network - Email Verification: Registered Nurses, Health Educators, and Social and Human Service Assistants No Health Health Care Services
0920-0255 Att5A_email_verification_instructionsTrack Yes Yes Fillable Fileable Form and instruction Att5A_email_verification_instructionsTrack.docx 0920-0255 Att5_email_verification_instructionsClean Yes Yes Fillable Fileable Form and instruction Att4A_email_verification_messageTrack.docx 0920-0255 Att4A_email_verification_messageTrack Yes Yes Fillable Fileable Form and instruction Att4 Email_verification_message.docx
Federal Government 3300 550 0

Resources and Services Database of the CDC National Prevention Information Network - Email Verification: Social and Community Service Managers No Health Health Care Services
0920-0255 Att4A_email_verification_messageTrack Yes Yes Fillable Fileable Form and instruction Att4A_email_verification_messageTrack.docx 0920-0255 Att5_email_verification_instructionsClean Yes Yes Fillable Fileable Form and instruction Att5_email_verification_instructionsClean.docx 0920-0255 Att5A_email_verification_instructionsTrack Yes Yes Fillable Fileable Form and instruction Att5A_email_verification_instructionsTrack.docx 0920-0255 Att4 Email_verification_message Yes Yes Fillable Fileable Form and instruction Att4 Email_verification_message.docx
Federal Government 300 60 0

Resources and Services Database of the CDC National Prevention Information Network - Email Verification: Health Educators No Health Health Care Services Federal Government 300 50 0

Resources and Services Database of the CDC National Prevention Information Network - Email Verification: Social and Human Service Assistants No Health Health Care Services Federal Government 0 0 0

2013-12-30-05:00

0920-0260 201109-0920-006 0920
             
        "Health Hazard Evaluations/Technical Assistance and Emerging Problems"
             
          
        
PL 91-596 and PL 91-173 mandate that CDC's National Institute for Occupational Safety and Health (NIOSH) respond to request for Health Hazard Evaluations (HHEs) to address chemical, biological, and/or physical workplace hazards. CDC requests revisions to data collection forms for the Health Hazard Evaluation/Technical Assistance and Emerging Problems information collection. 2014-11-30-05:00 Active Daniel Holcomb dwh6@cdc.gov 770 488-4472 No No No 8160 2874 0

Health Hazard Evaluation Specific Questionnaire (Example) No Health Illness Prevention
none HHE Evaluation Yes Yes Fillable Fileable Form Attachment F- updated.docx
Private Sector 3440 1720 0

Health Hazard Evaluation Request Form for Employees and Employers No Health Illness Prevention
none HHE Request Form Yes Yes Fillable Fileable Form Attachment C.pdf
Private Sector 320 64 0

Health Hazard Evaluation Specific Interview (Example) No Health Illness Prevention
none HHE Evaluation Ineview No Yes Fillable Fileable Form Attachment E updated.doc
Private Sector 3200 800 0

Initial and Follow-back for Onsite Evaluations Year 1 No Health Illness Prevention
none HHE Initial and Follow-back Yes Yes Fillable Fileable Form Attachment G- updated.docx
Private Sector 320 80 0

Follow-back without Onsite Evaluation Year 1 No Health Illness Prevention
none Followback no onsite Year 1 Yes Yes Fillable Fileable Form Attachment J.docx
Private Sector 120 20 0

Follow-back without Onsite Evaluation Year 2 No Health Illness Prevention
none Follow-back no onsite Year 2 Yes Yes Fillable Fileable Form Attachment K.docx
Private Sector 120 30 0

Followback for Onsite Evaluations Year 2 No Health Illness Prevention
none Followback Year 2 Yes No Fillable Fileable Form Attachment I.docx
Private Sector 320 80 0

Followback for Onsite Evaluations Year 1 No Health Illness Prevention
none Followback Year 1 Yes Yes Fillable Fileable Form Attachment H.docx
Private Sector 320 80 0

2011-11-17-05:00

0920-0263 201303-0920-003 0920
             
        "Requirements for the Importation of Nonhuman Primates into the United States"
             
          
        
Since May 1990, CDC has monitored the arrival of certain shipments of nonhuman primates inported into the United States. CDC is requesting revisions that streamline the permit process for the importers. 2016-04-30-04:00 Active Carol Walker 4046394773 No No No 476 145 0

Importer Registration and New Importer Registration - Nonhuman Primates No Health Immunization Management
none Application for Registration Yes Yes Fillable Fileable Form Attachment 6 CDC 75.10A Application for Registration as an Importer of Nonhuman Primates rev.pdf
Private Sector 13 2 0

Requirements for Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys into the United States (Businesses - extended) No Health Public Health Monitoring Private Sector 0 0 0

Requirements for Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys into the United States (organizations - extended) No Health Public Health Monitoring Private Sector 0 0 0

Registered Importer and New Importer Documentation No Health Immunization Management Private Sector 13 17 0

Record Keeping and Reporting Requirements No Health Immunization Management Private Sector 150 38 0

Quarantine Release No Health Immunization Management Private Sector 150 38 0

Filovirus Specimen Submission No Health Immunization Management
none Filovirus Yes Yes Fillable Fileable Form Attachment 7 Filovirus Diagnostic Specimen Submission Form for Non-human Primate Materials rev.docx
Individuals or Households 150 50 0

2013-04-16-04:00

0920-0278 201311-0920-002 0920
             
        "National Hospital Ambulatory Medical Care Survey"
             
          
        
This request is for approval of minor changes for 2014. The National Hospital Ambulatory Medical Care Survey (NHAMCS) is a national survey of patient visits to emergency departments, outpatient departments, and ambulatory surgery locations of general and short-stay hospitals, as well as freestanding ambulatory surgery centers. 2014-12-31-05:00 Active Carol Marsh cww6@cdc.gov 404 639-4773 Yes Yes No 132443 7352 0

Ambulatory Unit Induction No Health Public Health Monitoring Private Sector 1779 445 0

Cervical Cancer Screening Supplement No Health Public Health Monitoring
unnumbered Att. T. Cervical Cancer Screening Supplement Yes No Paper Only Form NHAMCS2010 Attachment T - NHAMCS-906.pdf
Private Sector 0 0 0

Hospital Induction Form No Health Public Health Monitoring
none Hospital Induction Interview Yes Yes Fillable Fileable Form Attachment E - 2014 Hospital Induction Interview.pdf
Private Sector 482 723 0

ED Patient Record Form No Health Public Health Monitoring
none ED Screenshots Yes Yes Fillable Fileable Form Attachment G - 2014 Emergency Department PRF Screenshots 103013.docx
Individuals or Households 11300 1318 0

ASL Patient Record Form No Health Public Health Monitoring
none Ambulatory Surgery Yes Yes Fillable Fileable Form Attachment H - 2014 Ambulatory Surgery PRF Screenshots 103013.docx
Individuals or Households 5400 630 0

OPD Patient Record Form No Health Public Health Monitoring
none OPD Screenshots Yes Yes Fillable Fileable Form Attachment F - 2014 Outpatient Department PRF Screenshots 103013.docx
Individuals or Households 15600 2600 0

Pulling and re-filing Patient Records No Health Public Health Monitoring Individuals or Households 97090 1618 0

Reabstraction Telephone Call No Health Immunization Management Private Sector 72 6 0

Medical Record Reabstraction No Health Immunization Management Private Sector 720 12 0

2013-11-05-05:00

0920-0307 201307-0920-009 0920
             
        "Gonococcal Isolate Surveillance Project"
             
          
        
The purpose of this revision is to request approval to change one of the current forms and to extend collection for an additional three years. The forms are used to collect surveillance data on antimicrobial resistance in Neisseria gonorrohoeae. These data are used by public health officials at the national, state, and local level to determine appropriate therapy for gonorrhea. In addition, the data are used to monitor trends N. gonorrhoeae antimicrobial resistance and certain epidemiologic aspects of gonorrhea. 2016-08-31-04:00 Active Petunia Gissendaner 4046390164 No No No 14700 8628 0

Form 1 - Demographic/Clinical Data No Health Public Health Monitoring
CDC73.60A Form 1: Demographic/Clinical Data Yes Yes Fillable Fileable Form Att 3a_Demo_ClinicData_FINAL.pdf
State, Local, and Tribal Governments 7200 1320 0

Form 2 - Antimicrobial Susceptibility Testing No Health Public Health Monitoring
none Antimicrobial Susceptablity Testing Yes Yes Fillable Fileable Form 0920-0307_GISP_Attachment 3b - Form 2 - 08.31.2010.doc
State, Local, and Tribal Governments 7260 7260 0

Form 3 - Control Strain Susceptibility Testing No Health Public Health Monitoring
none Control Strain Susceptability Testing Yes Yes Fillable Fileable Form 0920-0307_GISP_Attachment 3c - Form 3 - 08.31.2010.doc
State, Local, and Tribal Governments 240 48 0

2013-08-21-04:00

0920-0314 201302-0920-002 0920
             
        "National Survey of Family Growth"
             
          
        
The National Survey of Family Growth NSFG) is a nationally-representative sample survey conducted by personal interview among a sample of approximately 5,000 men and women annually. Data will be collected on pregnancy, contraception, parenting, and related attitudes. This request describes minimal questionnaire changes and a test to study changes in incentive levels. 2015-04-30-04:00 Active Petunia Gissendaner 4046390164 No No No 20400 7192 0

Female Interview Questionnaire -- No Health Public Health Monitoring
None Attachment 2: 2011-2015 National Survey of Family GrowthFEMALE Questionnaire(Mark-Up for Year 3 with red highlights) Yes Yes Fillable Fileable Form and instruction NSFG 2013 OMBChange_Att2_C8_Year3_Female_capilite_ red markup 012913.docx None Attachment 2: 2011-2015 National Survey of Family Growth FEMALE Questionnaire (Mark-Up for Year 3) Yes Yes Fillable Fileable Form and instruction NSFG 2013 OMBChange_Att2_C8_Year3_Female_capilite_clean 012913.docx
Individuals or Households 2750 4125 0

National Survey of Family Growth--Male Interview No Health Public Health Monitoring
None ATTACHMENT 3:2011-2015 National Survey of Family Growth MALE Questionnaire (Mark-Up for Year 3 with red highlights) Yes Yes Fillable Fileable Form and instruction NSFG 2013 OMBChange_Att3_C8_Year3_Male_capilite_red markup 012913.docx None ATTACHMENT 3:2011-2015 National Survey of Family Growth MALE Questionnaire(Mark-Up for Year 3) Yes Yes Fillable Fileable Form and instruction NSFG 2013 OMBChange_Att3_C8_Year3_Male_capilite_CLEAN 012913.docx
Individuals or Households 2250 2250 0

Verification form No Health Public Health Monitoring
K National Survey of Family Growth, Verification Questionnaires No No Fillable Fileable Form and instruction Attach K--Verification Quex.doc
Individuals or Households 1400 117 0

Household Screener No Health Public Health Monitoring
3 Household Screening Questionnaire Yes Yes Fillable Fileable Form and instruction NSFG 2009 ATTACH G4--Screener.doc
Individuals or Households 14000 700 0

2013-04-05-04:00

0920-0338 201212-0920-007 0920
             
        "Annual Submission of the Ingredients Added to, and the Quantity of Nicotine Contained in, Smokeless Manufactured, Imported, or Packaged in the U.S."
             
          
        
This is a legislatively mandated information collection. The Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 4401 et seq. or Pub.L. 99-252) requires each person who manufactures, packages, or imports smokeless tobacco products to provide the Secretary of HHS with an annual list of ingredients added to tobacco in the manufacture of smokeless tobacco products, as well as a specification of quantity of nicotine contained in each product. Responsibility for collecting the information has been delegated to CDC's Office on Smoking and Health. 2014-02-28-05:00 Active Thelma Sims 4046394771 No No No 13 22269 0

List of Ingredients Added in the Manufacture of Smokeless Tobacco Products No Health Public Health Monitoring Private Sector 13 22269 0

2013-02-04-05:00

0920-0406 201103-0920-007 0920
             
        "State and Local Area Integrated Telephone Survey (SLAITS)"
             
          
        
The State and Local Area Integrated Survey (SLAITS) mechanism developed by the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS) supplements current national data collection strategies by providing in-depth national state, and local area data. This flexible population-based survey mechanism is designed to collect data rapidly and cost effectively on abroad range of topics, and addresses a critical need for subnational data. This request is for a generic three-year clearance for this package. 2014-04-30-04:00 Active Petunia Gissendaner 4046390164 No No No 2118300 194675 0

2013 National Survey of Children in Nonparental Care No Health Immunization Management
none 2013 NSCNC Questionnaire Yes Yes Fillable Fileable Form and instruction SLAITS 2013 NSCNC OMB_attachment A 120612.docx
Individuals or Households 1600 800 0

National Survey of Children in Nonparental Care - revised questionnaire No Health Immunization Management
none National Survey of Children in Nonparental Care Yes Yes Fillable Fileable Form SLAITS 2013 NSCNC_OMB_revised QRE_attach A.docx
Individuals or Households 1 1 0

National Survey of the Diagnosis and Treatment of ADHD and Tourette Syndrome (NS-DATA) No Health Immunization Management
none 2014 NS-DATA Telephone Questionnaire Yes Yes Fillable Fileable Form OMB_Attachment A.docx
Individuals or Households 3700 1850 0

2011-04-25-04:00

0920-0445 201307-0920-004 0920
             
        "School Health Policies and Practices Study 2012"
             
          
        
CDC requests OMB approval to conduct a national study of school health policies and practices at the state, district, school, and classroom levels. Information will be collected in the spring of 2012. 2016-08-31-04:00 Active Thelma Sims 4046394771 No No No 13862 9722 0

School Health Education No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 640 214 0

School Physical Education and Activity No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 640 427 0

School Health Services No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 640 534 0

School Nutrition Services No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 640 427 0

Healthy and Safe School Environment No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 640 960 0

Classroom Data Collection No Education Elementary, Secondary, and Vocational Education
25 Health Education Classroom Questionnaire Yes Yes Fillable Fileable Form and instruction Appendix G-22 Physical Education_Classroom.doc 24 Health Education Classroom Questionnaire Yes Yes Fillable Fileable Form and instruction Appendix G-21 Health Education_Classroom.doc
State, Local, and Tribal Governments 0 0 0

Classroom Health Education No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 1229 1024 0

Classroom Physical Education and Activity No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 1229 819 0

District Health Education No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 685 343 0

School Mental Health and Social Services No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 640 320 0

School Faculty and Staff Health Promotion No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 640 214 0

District Physical Education and Activity No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 685 457 0

District Health Services No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 685 457 0

District Nutrition Services No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 685 343 0

District Healthy and Safe School Environment No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 685 685 0

District Mental Health and Social Services No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 685 343 0

District Faculty and Staff Health Promotion No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 685 229 0

District Recruitment Script (2014) No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 320 160 0

District Recruitment Script (2016) No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 902 902 0

State Recruitment Script (2014) No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 42 21 0

State Recruitment Script (2016) No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 44 22 0

School Recruitment Script No Education Elementary, Secondary, and Vocational Education State, Local, and Tribal Governments 821 821 0

2013-08-16-04:00

0920-0457 201307-0920-007 0920
             
        "Aggregate Reports for Tuberculosis Program Evaluation"
             
          
        
This is a request for extension of OMB approval of a previously approved collection, OMB No. 0920-0457 expiration date 9/30/2013. The Division of Tuberculosis Elimination (DTBE), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC) is submitting two public health report forms representing (1) denominator-based outcome measurements, (2) technology for data storage and transmission, and (3) the primary public health strategies for tuberculosis (TB) control. The respondents for the reports are the 68 state and local health departments having federal TB cooperative agreements. These health departments control TB by finding TB cases and ensuring the completion of therapy. To accelerate progress toward the national goal of TB elimination, strategies for finding and treating latent TB infection are critical. Two key components of these strategies are (1) evaluating persons who have been exposed to TB (i.e., contacts), and (2) testing among populations that have a high prevalence rate of latent TB infection or a high risk for TB disease (i.e., targeted testing). To monitor these two activities nationally, CDC collaborated with the respondents in designing two Aggregate Reports for Tuberculosis Program Evaluation. The data that are requested by CDC in these reports are not identifiable at the individual level and are submitted only in aggregate format. Both reports are used by the respondents in conjunction with DTBE, as indicator tools for program evaluation, as approximations of workload, and as general sources for epidemiological analysis. CDC uses the summary U.S. results in assessing the national progress toward TB elimination. 2016-08-31-04:00 Active Petunia Gissendaner 4046390164 No No No 272 226 0

Follow-up and Treatment of Contacts to Tuberculosis Case Form - Electronic (Data Clerks and Program Managers) No Health Illness Prevention
None Follow-up and Treatment of Contacts to Tuberculosis Case Form Yes Yes Fillable Printable Form and instruction Att 3a_Follow up and Treatment for Contacts to TB CasesForm.docx
State, Local, and Tribal Governments 100 50 0

0920-0457 - Follow-up and Treatment for Contacts to TB Cases - data clerks - manual No Health Illness Prevention
None 0920-0457 - Follow-up and Treatment for Contacts to TB Cases - data clerks - manual No No Paper Only Form and instruction Att 3a_Follow up and Treatment for Contacts to TB CasesForm.docx
State, Local, and Tribal Governments 18 54 0

0920-0457 - Follow-up and Treatment for Contacts to TB Cases - prog. managers - elect. No Health Illness Prevention
none Follow-up and Treatment Yes Yes Fillable Printable Form and instruction Attach C Contact Report Instructions.pdf
State, Local, and Tribal Governments 0 0 0

Follow-up and Treatment for Contacts to TB Cases - Managers- manual No Health Illness Prevention
None 0920-0457 - Follow-up and Treatment for Contacts to TB Cases - Program Managers- (Manual) No No Paper Only Form and instruction Att 3a_Follow up and Treatment for Contacts to TB CasesForm.docx
State, Local, and Tribal Governments 18 9 0

Targeted Testing and Treatment for Latent Tuberculosis Infection - Electronic (Data Clerks & Program Managers) No Health Illness Prevention
None Targeted Testing and Treatment for Latent Tuberculosis Infection - Electronic (Data Clerks & Program Managers) Yes Yes Fillable Printable Form and instruction Att 3b_Targeted Testing and Treatment for Latent TB InfectionForm.docx
State, Local, and Tribal Governments 100 50 0

Targeted Testing and Treatment for Latent TB Infection - data clerks - (manual) No Health Illness Prevention
None Targeted Testing and Treatment for Latent TB Infection - data clerks - (manual) No No Paper Only Form and instruction Att 3b_Targeted Testing and Treatment for Latent TB InfectionForm.docx
State, Local, and Tribal Governments 18 54 0

0920-0457 Targeted Testing and Treatment for Latent TB Infection - prog. manag. - elect. No Health Illness Prevention
none Targeted Testing and Treatment for Latent TB Infection Yes Yes Fillable Printable Form and instruction Attach D Targeted Testing Instructions.pdf
State, Local, and Tribal Governments 0 0 0

0920-0457 Targeted Testing and Treatment for Latent TB Infection - prog. manag. - manual No Health Illness Prevention
None Targeted Testing and Treatment for Latent TB Infection - Program Managers- (manual) No No Paper Only Form and instruction Att 3b_Targeted Testing and Treatment for Latent TB InfectionForm.docx
State, Local, and Tribal Governments 18 9 0

2013-08-21-04:00

0920-0469 201304-0920-016 0920
             
        "National Program of Cancer Registries Cancer Surveillance System (NPCR CSS)"
             
          
        
CDC's NPCR CSS collects cancer surveillance information from NPCR-funded states and territories regarding the types of cancer that occur (histology, morphology, and behavior), the anatomic location, the extent of disease at the time of diagnosis, the kinds of treatment received by cancer patients, and the outcomes of treatment and clinical management. Continued clearance for a three-year period is requested. 2016-05-31-04:00 Active Catina Conner 4046394775 Yes No No 96 192 0

National Program of Cancer Registries Cancer Surveillance System - Standard CSS Report No Health Immunization Management
0920-0469 Attachment 3a. Standard NPCR CSS Submission Specifications Yes Yes Fillable Printable Form and instruction Attachment 3a. Standard NPCR CSS Submission Specifications.zip
State, Local, and Tribal Governments 76 152 0

National Program of Cancer Registries Cancer Surveillance System - Enhanced CSS Report No Health Immunization Management
0920-0469 Attachment 3b. Enhanced NPCR CSS Submission Specifications Yes Yes Fillable Printable Form and instruction Attachment 3b. Enhanced NPCR CSS Submission Specifications.zip
State, Local, and Tribal Governments 20 40 0

2013-05-22-04:00

0920-0488 201302-0920-007 0920
             
        "Restrictions on Interstate Travel of Persons"
             
          
        
This ICR contains requirements under Reg. 42 CFR Part 70. 70.3 states a person with a communicable disease in the communicable period shall not travel from one State or possession to another without a health permit officer of the State, possession or locality of destination, if such permit is required. Part 70.4 requires that masters or operators of conveyances engaged in interstate travel report to the local health authority any instance of communicable disease that occur during travel. Part 70.5 requires that a person in the communicable period of cholera, plague, smallpox, typhus or yellow fever request a permit to travel from the Surgeon General or authorized representative. 2016-03-31-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 16900 3701 0

42 CFR 70.3 Applicant to State of Destination for a Permit No Health Immunization Management
none Restriction on Travel of Persons Yes Yes Fillable Fileable Form Attachment 3 Ill Person Travel Permit_Added.doc
Individuals or Households 2000 500 0

42 CFR 70.3 Copy of Materials - Attending Physician No Health Immunization Management
none Restriction on Travel of Persons Yes Yes Fillable Fileable Form Attachment 3 Ill Person Travel Permit_Added.doc
Private Sector 2000 500 0

42 CFR 70.4 Report by Master Vessel or Person in Charge of Conveyance No Health Immunization Management
none Restriction on Travel of Persons No No Printable Only Form Attachment 4 Master of Vessel or Conveyance Illness Report 101712.doc
Private Sector 1500 375 0

42 CFR 70.4 Copy of Materials for State or Local Health Authority No Health Immunization Management
none Restriction on Travel of Persons No No Printable Only Form Attachment 4 Master of Vessel or Conveyance Illness Report 101712.doc
State, Local, and Tribal Governments 1500 150 0

42 CFR 70.5 Application to Move from State to State - Communicable Period - Traveler No Health Immunization Management
none Restriction on Travel of Persons Yes Yes Fillable Fileable Form Attachment 3 Ill Person Travel Permit_Added.doc
Individuals or Households 3750 938 0

42 CFR 70.5 Application to Move from State to State - Communicable Period - Attending Physician No Health Immunization Management
none Restriction on Travel of Persons Yes Yes Fillable Fileable Form Attachment 3 Ill Person Travel Permit_Added.doc
Private Sector 3750 938 0

42 CFR 70.3 Permit Issued by State Health Authority No Health Immunization Management
none Restriction on Travel of Persons Yes Yes Fillable Fileable Form Attachment 3 Ill Person Travel Permit_Added.doc
State, Local, and Tribal Governments 2000 200 0

42 CFR 70.4 Report of Communcable Disease While in Interstate Travel by Master of Vessel No Health Immunization Management
none Restriction on Travel of Persons Yes Yes Fillable Fileable Form Attachment 4 Master of Vessel or Conveyance Illness Report 101712.doc
Private Sector 200 50 0

42 CFR 70.4 Copy of Material submitted to Health Authority No Health Immunization Management
none Restriction on Travel of Persons Yes Yes Fillable Fileable Form Attachment 4 Master of Vessel or Conveyance Illness Report 101712.doc
State, Local, and Tribal Governments 200 50 0

2013-03-20-04:00

0920-0493 201207-0920-009 0920
             
        "2013 - 2015 Youth Risk Behavior Surveys"
             
          
        
The school-based National Youth Risk Behavior Survey (YRBS) is a biennial survey of high school students that assesses priority health risk behaviors related to the major preventable causes of mortality, morbidity, and social problems in the U.S. 2015-09-30-04:00 Active Thelma Sims 4046394771 No No No 10794 7822 0

2013 and 2015 Youth Risk Behavior Survey No Health Public Health Monitoring Individuals or Households 10129 7597 0

2013 YRBS - State-Level Recruitment Script No Health Public Health Monitoring Individuals or Households 17 9 0

2013 YRBS - District-Level Recruitment Script No Health Public Health Monitoring Individuals or Households 80 40 0

2013 YRBS - School-Level Recruitment No Health Public Health Monitoring Individuals or Households 133 67 0

2013 YRBS - Data Collection Checklist No Health Public Health Monitoring Individuals or Households 435 109 0

2012-09-07-04:00

0920-0530 201201-0920-006 0920
             
        "EEOICPA Dose Reconstruction Interviews and Form"
             
          
        
NIOSH is charged with developing reasonable estimates of the radiation doses incurred occupationally by U.S. nuclear weapons workers with cancer that are covered by the Energy Employees Occupational Illness Compensation Program Act of 2000. These radiation dose reconstructions are completed using methods promulgated by HHS under 42 CFR 82. An essential data source for completing the dose reconstructions is the information collected through structured telephone interviews conducted with claimants, who may be energy employees or surviving family members. In some cases, if necessary, co-workers of the employee are interviewed. These individuals may have unique knowledge of work conditions, radiation protection measures, and monitoring practices that are not available from other sources. At the completion of the dose reconstruction process, claimants review the estimated radiation dose, and signify that they have no more relevant information to offer by submitting a conclusion form (OCAS-1). 2015-02-28-05:00 Active Thelma Sims 4046394771 No No No 12600 4900 0

EEOICPA Dose Reconstruction Introductory Letters & Telephone Interview No Health Illness Prevention Individuals or Households 4200 4200 0

EEOICPA Dose Reconstruction Interviews Conclusion Form No Health Illness Prevention Individuals or Households 8400 700 0

2012-02-13-05:00

0920-0556 201207-0920-008 0920
             
        "Assisted Reproductive Technology (ART) Program Reporting System"
             
          
        
CDC currently collects and reports informaton from all clinics that offer assisted reproductive technology (ART) services, as required by the Fertility Clinic Success Rate and Certification Act (FCSRCA). CDC seeks to renew OMB approval for an additional three years. 2015-08-31-04:00 Active Thelma Sims 4046394771 No No No 149336 96960 0

Assisted Reproductive Technology (ART) Program Reporting System No Health Public Health Monitoring Private Sector 149160 96954 0

Feedback Survey No Health Immunization Management Private Sector 176 6 0

2012-08-31-04:00

0920-0566 201205-0920-006 0920
             
        "Using a Reader Response Card to Assess Worker Notification Materials"
             
          
        
Since 1977, NIOSH has been developing methods and materials for the notification of subjects of its epidemiological studies. To assess the effectiveness of the notification materials and to improve future communication of risk information, the evaluation instrument proposed (a reader response evaluation card) was developed for routine use. 2015-08-31-04:00 Active Catina Conner 4046394775 No No No 8000 1333 0

Evaluation of Worker Notification Program Response Card No Health Public Health Monitoring
0920-0566 Attachment C Response Card Yes Yes Fillable Printable Form and instruction Attach-C (2) .docx
Individuals or Households 8000 1333 0

2012-08-02-04:00

0920-0571 201209-0920-001 0920
             
        "Minimum Data Elements for the National Breast and Cervical Cancer Early Detection Program"
             
          
        
The CDC-funded National Breast and Cervical Cancer Early Detection Program (NBCCEDP) is the largest organized cancer screening program in the United States, providing critical breast and cervical cancer screening services to underserved women. CDC proposes to continue the collection of performance indicator information from NBCCEDP grantees. The information supports program planning, evaluation, and research. 2015-10-31-04:00 Active Carol Walker 4046394773 No No No 134 536 0

Minimum Data Elements/System for Technical Assistance Reporting for the National Breast and Cervical Cancer Early Detection Program No Health Immunization Management
none MDE Data Items and Definitions Required for Reporting Yes Yes Fillable Fileable Form and instruction Attachment 03a (MDE data items).pdf none Web-based Portal Screenshot Yes Yes Fillable Fileable Form Attachment 03b (Web-based portal).pdf
State, Local, and Tribal Governments 134 536 0

2012-10-05-04:00

0920-0572 201111-0920-003 0920
             
        "CDC and ATSDR Health Message Testing System"
             
          
        
CDC must communicate about hazards, outbreaks and other emergencies that present an urgent health threat to the public. Untested messages can waste communication resources and opportunities because the messages can be perceived as unclear or irrelevant. NCHM is requesting continuing approval for an expedited review of items to be used in health messgae testing to ensure the public will understand health messages and take recommended actions. 2015-02-28-05:00 Active Thelma Sims 4046394771 No No No 55575 7410 0

Act Against AIDS Campaign No Health Immunization Management
none Screener - MSM No No Paper Only Form and instruction Act Against AIDS - MSM Screening Instrument.docx none Interview - MSM No No Paper Only Form and instruction Act Against AIDS - MSM Interview Guide.docx none Screener - HIV+ No No Paper Only Form and instruction Act Against AIDS - HIV+ Screening Instrument.docx none Interview - HIV+ No No Paper Only Form and instruction Act Against AIDS - HIV+ Interview Guide.docx none Interview - General Population No No Paper Only Form and instruction Act Against AIDS - Intercept Interview Guide.docx none Invitation - General Population No No Paper Only Form and instruction Act Against AIDS - Script Invitation for Eligible.docx
Individuals or Households 1420 385 0

Pandemic Influenza Nonpharmaceutical Intervention Message Testing No Health Immunization Management
none Screener No No Paper Only Form and instruction Screener Protocol 071312.docx none Moderator's Guide No No Paper Only Form and instruction Moderator Guide_071312.docx
Individuals or Households 90 180 0

Message Testing for CDCs Division of Community Health with the General Public, Engaged Public, and Community Leaders No Health Public Health Monitoring
0920-0572 Moderators Guide- Engaged Public Triad Yes Yes Fillable Printable Form and instruction Moderators Guide- Engaged Public Triad.docx Yes Yes Printable Only Instruction DCH Screener- General Public FG Engaged Public Triad.docx 0920-0572 Moderators Guide- Community Leaders Triad Yes Yes Printable Only Form and instruction Moderators Guide- Community Leaders Triad.docx 0920-0572 Moderators Guide- General Public FG Yes Yes Fillable Printable Form and instruction Moderators Guide- General Public FG.docx Yes Yes Printable Only Instruction Consent form- Community Leaders Triad.docx Yes Yes Printable Only Instruction Consent form- Engaged Public Triad.docx Yes Yes Printable Only Instruction Consent form- General Public FG.docx
Individuals or Households 336 492 0

Msg Testing for (3) Expedited Reviews--Detonation of an Improv Nuc Devise (Span), AND Impact of a Truck Driver Pub Hth Prac Proj, AND Dissemination of Occup Safety & Hlth Materials thru Mex Consul No Health Public Health Monitoring
none Screening Instrument Yes Yes Fillable Printable Form Attachment C - Screening Instrument.docx Yes Yes Paper Only Instruction Attachment E - Participant Information Sheet.docx Yes Yes Printable Only Other Attachment C- Screen Shots.pdf Yes Yes Printable Only Other Attachment D - Sleep Debt PSA_30 seconds.mp3 Yes Yes Printable Only Other Attachment F - Whole World Changes PSA_60 seconds.mp3 Yes Yes Printable Only Other Attachment E - Whole World Changes PSA_30 seconds.mp3 none Truck Driver Opinion Survey Yes Yes Fillable Printable Form Attachment B - Truck Driver Opinion Survey.docx Yes Yes Printable Only Other Attachment B-Recruitment Script_Spanish.docx Yes Yes Printable Only Other Attachment C-Recruitment Script_English Translation.docx none Exit Survey_Spanish Yes Yes Printable Only Form Attachment D-Exit Survey_Spanish.docx Yes Yes Printable Only Other FinalScript_English_051812.doc none Exit Survey_English Translation Yes Yes Printable Only Form Attachment E-Exit Survey_English Translation.docx Yes Yes Printable Only Other FinalScript_Spanish_051812.doc Yes Yes Printable Only Other GeneralTest113012v01.pdf Yes Yes Printable Only Instruction Attachment D - Moderator's Guide.docx Yes Yes Printable Only Other SoftskillsTest120312v01.pdf Yes Yes Printable Only Other HotelTest113012v01.pdf
Individuals or Households 644 199 0

Planes,Trains and Auto-Mobility: Increase Walking in the Atl Hartsfield-Jackson Arprt And Testing of brand concepts, msgs and material CDC National Diabetes Prevntion Program No Health Consumer Health and Safety
0920-0572 Plane, Trains and Auto Appendix B 1 Interview 1 Yes Yes Fillable Fileable Form and instruction Appendix B1 Interview 1.docx 0920-0572 Planes, Trains and Auto Appendix B Instructions for Interview Yes Yes Fillable Fileable Form and instruction Appendix B Instructions for Interviewers 1.docx 0920-0572 Planes, Trains and Autop Appendix B3 Response Form Yes Yes Fillable Fileable Form and instruction Appendix B3 Response Form.docx 0920-0572 Testing of brand Appendix D2-NDPP Branding Message Testing Supplement Yes Yes Fillable Fileable Form and instruction Appendix D2-NDPP Branding Message Testing Supplement 010713.docx 0920-0572 Testing of brands Appendix C2-Moderators Guide- HCP triads Yes Yes Fillable Fileable Form and instruction Appendix C2-Moderators Guide- HCP triads 020613.docx 0920-0572 Testing of Brand Appendix C1-Moderators Guide- Consumers FG Yes Yes Fillable Fileable Form and instruction Appendix C1-Moderators Guide- Consumers FG 020613.docx 0920-0572 Planes, Trains and Autop Appendix B2 Interview Cards 1 Yes Yes Fillable Fileable Form and instruction Appendix B2 Interview 1 Cards.pptx 0920-0572 Planes, Trains Auto Appendix B4 Participant Inform Yes Yes Fillable Fileable Form and instruction Appendix B4 Participant Information Sheet.docx 0920-0572 Testing of brand concepts Appendix B1-Consent form Yes Yes Fillable Fileable Form and instruction Appendix B1-Consent form-Consumer FGs 122812.docx 0920-0572 Testing of brand concepts Appendix A2-Screener-HCP Yes Yes Fillable Fileable Form and instruction Appendix A2-Screener-HCP 010713.docx 0920-0572 Testing of brand Appendix A1-Screener-Consumers 010 Yes Yes Fillable Fileable Form and instruction Appendix A1-Screener-Consumers 010713.docx 0920-0572 Plane, Train Auto Appendix C Handheld Screenshots Yes Yes Fillable Fileable Form and instruction Appendix C Handheld Screenshots.docx 0920-0572 Testing of brand concepts Appendix B2-Consent form- Yes Yes Fillable Fileable Form and instruction Appendix B2-Consent form-HCP Triads 122812.docx 0920-0572 Plane, Trains and Auto Appendix 5 Question 1 Rationale Yes Yes Fillable Fileable Form and instruction Appendix B5 Question 1 Rationale_v2.docx
Individuals or Households 344 261 0

African American STD Disparities Health Communications Project and Community Health Media Center Educational Campaign Materials Testing No Health Immunization Management
none Community Health Wave 4 Survey Screenshots Yes Yes Fillable Fileable Form Attachment 5c - Wave 4 Healthy Living - Screenshots - 040413.pdf none Community Health Wave 3 Survey Screenshots Yes Yes Fillable Fileable Form Attachment 4c - Wave 3 Food - Screenshots - 040413.pdf none Community Health Wave 2 Survey Screenshots Yes Yes Fillable Fileable Form Attachment 3c - Wave 2 Physical Activity - Screenshots - 040413.pdf none Community Health Wave 1 Survey Screenshots Yes Yes Fillable Fileable Form Attachment 2c - Wave 1 Beverages - Screenshots - 040413.pdf none Community Health Wave 4 Screener Yes Yes Fillable Fileable Form Attachment 5a - Wave 4 Healthy Living - Screener - 040413.pdf none Community Health Wave 3 Screener Yes Yes Fillable Fileable Form Attachment 4a - Wave 3 Food - Screener - 040413.pdf none Community Health Wave 2 Screener Yes Yes Fillable Fileable Form Attachment 3a - Wave 2 Physical Activity - Screener - 040413.pdf none Community Health Wave 1 Screener Yes Yes Fillable Fileable Form Attachment 2a - Wave 1 Beverages - Screener - 040413.pdf none African American Survey Yes Yes Fillable Fileable Form African Amer - Attachment 4 - Survey 022513.doc none African American Screener Yes Yes Fillable Fileable Form African Amer - Attachment 3 - Survey screener 040313.doc
Individuals or Households 5950 2406 0

Audience Research on Self-Management Education No Health Immunization Management
none Screener Yes No Fillable Printable Form and instruction Attachment 2 - Eligibility Screener 052313.docx none Moderator's Guide No No Printable Only Form and instruction Attachment 3 - Moderators Guide 052313.docx
Individuals or Households 120 200 0

Communities Putting Prevention to Work (CPPW) National Prevention Media Initiative Focus Group with Parents/Caregivers No Health Immunization Management Individuals or Households 120 154 0

Radiation Emergencies Infographics Focus Groups No Disaster Management Disaster Preparedness and Planning
Yes No Printable Only Other AttE RIG Moderator's Guide 20130828.docx None Screening Instrument-Radiation Emergencies Infographics Yes No Printable Only Form AttC RIG Screening Instrument 20130828.docx
Individuals or Households 288 192 0

HMTS Radiation Focus Group and Emergencies Infographics No Disaster Management Disaster Preparedness and Planning Individuals or Households 2088 372 0

Communities Putting Prevention to Work (CPPW) National Media Initiative -- Message Testing No Health Immunization Management State, Local, and Tribal Governments 300 60 0

Testing Health Messages in STEADI Oder Adult Fall Pevention Materials Among Caregivers No Health Immunization Management
Yes No Paper Only Other Appendix A - Informal Caregiver Discussion Guide.docx Yes No Paper Only Instruction Appendix C - Formal Caregiver Recruiting Script.docx Yes No Paper Only Other Appendix D - Formal Caregiver Discussion Guide.docx None Informed Consent Yes No Paper Only Form Appendix E - Informed Consent.docx Yes No Paper Only Other Appendix F - Check for Safety Fact Sheet.pdf Yes No Paper Only Other Appendix G - Stay Independent.pdf Yes No Paper Only Other Appendix H - What You Can Do to Prevent Falls.pdf Yes No Paper Only Instruction Appendix B - Informal Caregiver Recruiting Script.docx
Private Sector 244 128 0

2012-02-06-05:00

0920-0573 201301-0920-001 0920
             
        "National HIV Surveillance System (NHSS)  "
             
          
        
The Centers for Disease Control and Prevention (CDC) requests approval for revisions to a previously approved project 0920-0573 expiration 01/31/2013 called "National HIV Surveillance System (NHSS)" for a period of 3 years. The Division of HIV/AIDS Prevention (DHAP), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), CDC in collaboration with health departments in the states, the D.C., and U.S. dependent areas, conducts national surveillance for cases of human immunodeficiency virus (HIV) infection that includes critical data across the spectrum of HIV disease from HIV diagnosis, to acquired immunodeficiency syndrome (AIDS), the end-stage disease caused by infection with HIV, and death. The revisions requested in this extension include modifications to currently collected data elements and forms to align with anticipated changes in the case definitions for HIV surveillance to be published in 2012 and continuation of HIV surveillance activities funded under the new funding opportunity announcement CDC-RFA-PS13-1302 NATIONAL HIV SURVEILLANCE SYSTEM (NHSS). These include minor modifications of testing categories to accommodate new testing algorithms and modifications to staging criteria and non-substantial editorial changes aimed at improving the format and usability of the forms such as improved wording of terms and changes in the format of some response options. In addition, elements from the former enhanced perinatal surveillance (EPS) were reduced and the form is modified for continuation in 2013 as Perinatal HIV Exposure Reporting (PHER). Surveillance data collection on variant and atypical strains (formerly variant, atypical and resistant HIV surveillance (VARHS)) will also be continued as Molecular HIV Surveillance (MHS) with a reduced number of data elements previously approved under VARHS. 2016-02-29-05:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 639008 53700 0

Adult HIV/AIDS Confidential Case Report No Health Public Health Monitoring
0920-0573 Adult HIV Confidential Case Report Form Yes Yes Fillable Printable Form and instruction Final Att-3a Adult CRF (2).pdf
State, Local, and Tribal Governments 74340 24780 0

Pediatric HIV/AIDS Confidential Case Report No Health Public Health Monitoring
0920-0573 Pediatric HIV Confidential Case Report Form Yes Yes Fillable Printable Form Final Att-3b Ped CRF (2).pdf
State, Local, and Tribal Governments 354 118 0

Case Report Updates No Health Public Health Monitoring
none Pediatric HIV/AIDS Confidential Case Report Yes Yes Fillable Fileable Form 0920-0573_att 3(b) pediatric CDC 50 42B_wcover.pdf 0920-0573 Final Att-3a Adult CRF (2) Yes Yes Fillable Printable Form and instruction Final Att-3a Adult CRF (2).pdf
State, Local, and Tribal Governments 86671 2889 0

HIV Incidence Surveillance Data Elements No Health Public Health Monitoring State, Local, and Tribal Governments 0 0 0

HIV Incidence Surveillance (HIS) No Health Public Health Monitoring
0920-0573 Final Att 4c_Incidence TG append (2) Yes Yes Fillable Printable Form and instruction Final Att 4c_Incidence TG append (2).pdf
State, Local, and Tribal Governments 68225 11371 0

Perinatal HIV Exposure Reporting (PHER) No Health Public Health Monitoring
0920-0573 Final Att-3e PHER Form (2) Yes Yes Fillable Printable Form and instruction Final Att-3e PHER Form (2).pdf
State, Local, and Tribal Governments 3990 1995 0

Case Report Evaluation No Health Public Health Monitoring State, Local, and Tribal Governments 7493 2498 0

Laboratory Updates No Health Public Health Monitoring
0920-0573 Final Att 5_2009-2012 Publications Yes Yes Fillable Printable Form and instruction Final Att 5_2009-2012 Publications.pdf
State, Local, and Tribal Governments 346684 5778 0

Molecular HIV Surveillance (MHS) No Health Illness Prevention
0920-0573 Final Att 3d_MHS data elements (2) Yes Yes Fillable Printable Form and instruction Final Att 3d_MHS data elements (2).pdf
State, Local, and Tribal Governments 51251 4271 0

2013-02-13-05:00

0920-0576 201306-0920-002 0920
             
        "Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)"
             
          
        
CDC is requesting continued OMB approval to collect information through the use of five separate forms. These forms are: 1) Application for Registration, 2) Request to Transfer Select Agent or Toxin, 3) Report of Theft, Loss, or Release of Select Agent and Toxin, 4) Report of Identification of Select Agent or Toxin, and 5) Request for Exemption. The Application for Registration (42 CFR 73.7(d)) will be used by entities to register with CDC. The Application for Registration requests facility information; a list of select agents or toxins in use, possession, or for transfer by the entity; characterization of the select agent or toxin; and laboratory information. The Request to Transfer Select Agent or Toxin form (42 CFR 73.16) will be used by entities requesting transfer of a select agent or toxin to their facility. The Report of Theft, Loss, or Release of Select Agent and Toxin form (42 CFR 73.19(a)(b)) must be completed by entities whenever there is theft, loss, or release of a select agent or toxin. The Report of Identification of Select Agent or Toxin form 42 CFR 73.5(a)(b) and 73.6(a)(b)) will be used by clinical and diagnostic laboratories to notify CDC that select agents or toxins identified as the result of diagnostic or proficiency testing have been disposed of in a proper manner. In addition, the form will be used by Federal law enforcement agencies to report the seizure and final disposition of select agents and toxins. The Request for Exemption form (42 CFR 73.5 (d)(e) and 73.6 (d)(e)) will be used by entities that are using an investigational product that are, bear, or contain select agents or toxins or in cases of public health emergency. 2015-11-30-05:00 Active Carol Walker 4046394773 No No No 6370 8923 0

Application for Registration No Health Consumer Health and Safety
none Application for Registration Yes No Fillable Printable Form Revised Form 1 Application for Registration_2013-05-20_cl.docx
State, Local, and Tribal Governments 5 68 0

Request to Transer Select Agent or Toxin No Health Immunization Management State, Local, and Tribal Governments 320 480 0

Notification of Theft, Loss or Release No Health Immunization Management State, Local, and Tribal Governments 180 180 0

Report of Identification of Select Agent or Toxin No Health Immunization Management State, Local, and Tribal Governments 2880 2880 0

Request for Exemption No Health Immunization Management State, Local, and Tribal Governments 3 3 0

Request for Expedited Review No Health Immunization Management State, Local, and Tribal Governments 1 1 0

Request for Exclusion/Restricted No Health Immunization Management State, Local, and Tribal Governments 71 71 0

Adminstrative Review No Health Immunization Management Private Sector 30 120 0

Amendment to Registration Application No Health Immunization Management Private Sector 2560 2560 0

Inspections No Health Immunization Management State, Local, and Tribal Governments 320 2560 0

2013-06-11-04:00

0920-0591 201106-0920-010 0920
             
        "Select Agent Distribution Activity:  Request for Select Agent"
             
          
        
CDC is requesting OMB approval to reinstate without change, OMB Control No. 0920-0591: Select Agent Distribution Activity: Request for Select Agent. The purpose of this project is to provide a systematic and consistent mechanism to review requests that come to CDC for Select Agents. The Select Agent Distribution Activity (SADA) will use the information to evaluate the appropriateness of requests for Select Agents. 2014-07-31-04:00 Active Thelma Sims 4046394771 No No No 900 450 47700

Select Agent Distribution Activity Application No Health Public Health Monitoring Private Sector 900 450 47700

2011-07-20-04:00

0920-0600 201311-0920-007 0920
             
        "CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis and Nontuberculous Mycobacteria Drug Susceptibility Testing"
             
          
        
As part of the continuing effort to assess and monitor the quality and effectiveness of laboratory testing systems which support public health objectives of tuberculosis treatment programs, the CDC Model Performance Evaluation Program (MPEP) was established to analyze the performance and practices of all known clinical and public health laboratories in the United States that perform drug susceptibility testing of isolates belonging to the Mycobacterium tuberculosis complex (MTBC). Adequate TB control depends on rapid isolation and identification of the etiologic agent, M. tuberculosis, and confirmation of the appropriate therapeutic regimen by anti-tuberculosis drug susceptibility testing. Respondents consist of staff at domestic laboratories that perform drug susceptibility testing on isolates of M. tuberculosis. Information collected will be used to evaluate and improve competency of staff and ensure the quality of test procedures being performed on clinical specimens. 2016-05-31-04:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 558 156 0

Participant Biosafety Compliance Letter of Agreement No Health Health Care Services
none Attachment D: Participant Biosafety Compliance Letter of Agreement Yes Yes Fillable Fileable Form and instruction Att D Participant Biosafety Compliance Letter.docx
State, Local, and Tribal Governments 186 16 0

MPEP Mycobacterium Tuberculosis Results No Health Health Care Services
Yes Yes Printable Only Instruction MPEP M tuberculosis worksheet changes reflected.docx 0920-0600 Att C M tuberculosis Results Worksheet Yes Yes Fillable Fileable Form and instruction Att C M tuberculosis Results Worksheet.docx
State, Local, and Tribal Governments 186 93 0

Online Survey Instrument No Health Health Care Services
0920-0600 Att D Survey Instrument Web Shots Clean Yes Yes Fillable Fileable Form and instruction Att D Survey Instrument Web Shots Clean.docx
State, Local, and Tribal Governments 186 47 0

2013-11-14-05:00

0920-0604 201302-0920-018 0920
             
        "School Associated Violent Deaths Surveillance System"
             
          
        
CDC is requesting reinstatement of this surveillance system which remains the only systematic effort to document school-associated violent deaths on a national basis. Despite the important role of schools as a setting for violence research and prevention interventions, relatively little scientific or systematic work has been done to describe the nature and level of fatal violence associated with schools. The surveillance system will continue to contribute to the understanding of fatal violence associated with schools, guide further research in the area, and help direct ongoing and future prevention programs. 2016-04-30-04:00 Active Carol Walker 4046394773 No No No 70 70 0

Interview - School Officials No Health Immunization Management Individuals or Households 35 35 0

Interview - Law Enforcement Officials No Health Immunization Management State, Local, and Tribal Governments 35 35 0

2013-04-23-04:00

0920-0607 201306-0920-007 0920
             
        "The National Violent Death Reporting System (NVDRS)"
             
          
        
The proposed changes will ehance the security, reliability, scalability and quality of NVDRS by replacing the current distributed software system operated by funded states; streamlining data abstraction; and adding a small number of data elements identified by state users or CDC scentists. 2015-12-31-05:00 Active Thelma Sims 4046394771 No No No 54000 67500 0

State Health Department Case abstraction No Health Immunization Management State, Local, and Tribal Governments 27000 54000 0

Public Agencies Retrieving and refile No Health Immunization Management State, Local, and Tribal Governments 27000 13500 0

2013-06-14-04:00

0920-0612 201310-0920-006 0920
             
        "Well-Integrated Screening and Evaluation for Women Across the Nation(WISEWOMAN) Reporting System"
             
          
        
CDC plans to collect information from 21 WISEWOMAN program awardees. In 2013 new cooperative agreements were awarded with modified reporting requirements that reflect CDC's increased emphasis on program outcomes. The information collection consists of grantee progress reports and minimum data elements (MDE) that describe the screening, assessment, and lifestyle intervention services provided to women through the WISEWOMAN program. 2016-12-31-05:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 63 1344 0

Combined MDE for Screening and Assessment MDE and Lifestyle Program MDE No Health Health Care Services
0920-0612 Attachment 3b Summary of MDE Changes Yes Yes Fillable Fileable Form and instruction Attachment 3b Summary of MDE Changes 091913IV.docx 0920-0612 Attachment 3a WISEWOMAN MDE Version 9 Yes Yes Fillable Fileable Form and instruction Attachment 3a WISEWOMAN MDE Version 9 00_08 08 2013.docx
State, Local, and Tribal Governments 42 1008 0

Lifestyle Intervention Minimum Data Elements (MDEs) No Health Health Care Services State, Local, and Tribal Governments 0 0 0

Annual Progress Report No Health Health Care Services State, Local, and Tribal Governments 21 336 0

2013-12-02-05:00

0920-0621 201309-0920-012 0920
             
        "2012 - 2014 National Youth Tobacco Survey (NYTS)"
             
          
        
CDC requests minor changes to the National Tobacco Youth Survey questionnaire to cycle out Center for Tobacco Products questions from 2012 and cycle in Office of Smoking and Health questions for 2013. 2015-01-31-05:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 25836 18862 0

RECRUITMENT OF STATES No Health Public Health Monitoring State, Local, and Tribal Governments 35 18 0

RECRUITMENT OF DISTRICTS No Health Public Health Monitoring State, Local, and Tribal Governments 150 75 0

RECRUITMENT OF SCHOOLS No Health Public Health Monitoring State, Local, and Tribal Governments 244 122 0

TEACHERS' DATA COLLECTION CHECKLIST No Health Public Health Monitoring State, Local, and Tribal Governments 816 204 0

STUDENTS 2012 - 2014 NATIONAL YOUTH TOBACCO SURVEYS No Health Public Health Monitoring
None National Youth Tobacco Survey 2014 Yes Yes Fillable Fileable Form Attachment I-1, 2014 NYTS Instrument 2013.09.16.docx Yes Yes Fillable Printable Other Attachment I-7. Questionnaire Administration Guide_12 20 2011.doc
State, Local, and Tribal Governments 24591 18443 0

2013-10-18-04:00

0920-0636 201104-0920-013 0920
             
        "Centers for Disease Control and Prevention (CDC) Secure Public Health Emergency Response Communications Network (Epi-X)"
             
          
        
The Epidemic Information Exchange (Epi-X) is CDC's Web-based communication system for securely communicating in immediate anticipation of and during public health emergencies that have multi-jurisdictional impacts and implications. Proposed data collection instruments under this generic ICR will be designed to ensure ready access to public health and disease epidemiology information following a public health incident emergency response. 2014-05-31-04:00 Active Daniel Holcomb dwh6@cdc.gov 770 488-4472 No No No 348 73200 0 2011-05-02-04:00

0920-0639 201305-0920-013 0920
             
        "EEOICPA Special Exposure Cohort Petition Forms (42 CFR Part 8)"
             
          
        
The Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384-7385 [1994, supp. 2001], established a compensation program to provide a lump sum payment of $150,000 and medical benefits as compensation to covered employees suffering from designated illnesses incurred as a result of their exposure to radiation, beryllium, or silica while in the performance of duty for the Department of Energy and certain of its vendors, contractors and subcontractors. Among other duties, the executive order directed HHS to establish and implement procedures for considering petitions by classes of nuclear weapons workers to be added to the "Special Exposure Cohort" (the "Cohort"), a cohort of various groups of workers selected by Congress whose claims for cancer under EEOICPA can be adjudicated without demonstrating that their cancer was "at least as likely as not" caused by radiation doses they incurred in the performance of duty. In brief, EEOICPA authorizes HHS to designate such classes of employees for addition to the Cohort when HHS lacks sufficient information to estimate with sufficient accuracy the radiation doses of the employees. 2016-07-31-04:00 Active Carol Walker 4046394773 No No No 23 51 0

Form A 42 CFR 83.9 No Income Security Survivor Compensation Individuals or Households 5 1 0

Form B 42 CFR Part 83.9 No Income Security Survivor Compensation
none Form B Yes No Fillable Printable Form Attachment D SEC Form B.docx
Individuals or Households 8 40 0

Petitioner Submission Format other than Form B 42 CFR 83.9 No Income Security Survivor Compensation Individuals or Households 1 6 0

Petitioner Appealing Final Decision under 42 CFR 83.18 No Income Security Survivor Compensation Individuals or Households 4 3 0

Authorization Form on behalf of Claimant under 42 CFR 83.7 No Income Security Survivor Compensation Individuals or Households 5 1 0

2013-07-01-04:00

0920-0650 201303-0920-013 0920
             
        "Prevention Research Centers Program National Evaluation Reporting System"
             
          
        
CDC provides funding to 37 Prevention Research Centers which are housed within schools of public health, medicine or osteopathy. PRCs conduct outcomes-oriented health promotion and disease prevention research on a broad range of topics using a multi-disciplinary and community-based approach. CDC plans to continue collecting information from PRCs to monitor progress and activities. 2016-05-31-04:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 74 204 0

PRC Indicator Survey No Health Immunization Management
none PRC Indicator Data Collection Web Survey Yes Yes Fillable Fileable Form Attachment 4A_Webbased survey_2272013.doc none PRC Indicator Data Collection Web Survey Yes Yes Fillable Fileable Form Attatchment 4B_WebSurvey_ScreenShots2.docx
State, Local, and Tribal Governments 37 185 0

PRC Telephone Interview No Health Immunization Management
none Telephone Interview No No Printable Only Form Attachment 5. Telephone Interview_2 13 2013.docx
State, Local, and Tribal Governments 37 19 0

2013-05-13-04:00

0920-0666 201308-0920-010 0920
             
        "The National Healthcare Safety Network (NHSN)"
             
          
        
NHSN is a system designed to accumulate, exchange, and integrate relevant information and resources among private and public stakeholders to support local and national efforts to protect patients and promote healthcare safety. The data are used to determine the magnitude of various healthcare-associated adverse events and trends in the rates of these events among patients and healthcare workers with similar risks,and to detect changes in the epidemiology of adverse events resulting from new and current medical therapies and changing risks. The NHSN has six components: Patient Safety, Healthcare Personnel Safety, Biovigilance,Long-Term Care Facility, Dialysis, and Outpatient Procedure. 2016-10-31-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 8810700 4104776 138604613

57.106 Patient Safety Monthly Reporting Plan No Health Health Care Services
57.106 Patient Safety Monthly Reporting Plan Yes Yes Fillable Fileable Form 57.106_PSReportPlan_BLANK.DOCX
Private Sector 72000 42000 1589280

57.203 Healthcare Personnel Safety Reporting Plan No Health Health Care Services
57.203 Healthcare Personnel Safety Monthly Reporting Plan Yes Yes Fillable Fileable Form 57.203_HCPSafetyPlan_BLANK.DOCX
Private Sector 450 75 2989

57.500 Outpatient Dialysis Center Practices Survey No Health Health Care Services
57.500 Outpatient Dialysis Center Practices Survey Yes Yes Fillable Fileable Form 57.500_OutpatientDialysisSurv_BLANK.DOCX
Private Sector 6000 10500 340560

57.108 Primary Bloodstream Infection (BSI) No Health Health Care Services
57.108 Primary Bloodstream Infection Yes Yes Fillable Fileable Form 57.108_PrimaryBSI_BLANK.DOCX
Private Sector 216000 115200 4359168

57.502 Dialysis Event No Health Health Care Services
57.502 Dialysis Event Yes Yes Fillable Fileable Form 57.502_DIAL_BLANK.DOCX
Private Sector 360000 78000 2455440

57.111 Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram) No Health Health Care Services
57.111 Pneumonia (PNEU) Yes Yes Fillable Fileable Form 57.111_PNEU_BLANK.DOCX
Private Sector 432000 208800 7900992

57.210 Healthcare Worker Prophylaxis/Treatment - Influenza No Health Health Care Services
57.210 HCW Prophylaxis/Treatment-Influenza Yes Yes Fillable Fileable Form 57.210_HCWFluMedAdmin_BLANK.DOCX
Private Sector 2500 417 16604

57.114 Urinary Tract Infection (UTI) No Health Health Care Services
57.114 Urinary Tract Infection Yes Yes Fillable Fileable Form 57.114_UTI_BLANK.DOCX
Private Sector 162000 78300 2962872

57.116 Denominators for Neonatal Intensive Care Unit (NICU) No Health Health Care Services
57.116 Denominators for the Neonatal Intensive Care Unit Yes Yes Fillable Fileable Form 57.116_DenominatorNICU_BLANK.DOCX
Private Sector 54000 162000 5099760

57.125 Central Line Insertion Practices Adherence Monitoring Form No Health Health Care Services
57.125 Central Line Insertion Practices Adherence Monitoring Yes Yes Fillable Fileable Form 57.125_CLIP_BLANK.DOCX
Private Sector 100000 8333 315333

57.117 Denominators for Specialty Care Area (SCA)/Onocology (ONC) No Health Public Health Monitoring
57.117 Denominators for Specialty Care Area Yes Yes Fillable Fileable Form 57.117_DenominatorSCA_BLANK.DOCX
Private Sector 54000 270000 8449600

57.207 Follow-up Laboratory Testing No Health Health Care Services
57.207 Follow-up Lab Testing Yes Yes Fillable Fileable Form 57.207_LabTesting_BLANK.DOCX
Private Sector 2500 625 11188

57.118 Denominators for Intensive Care Unit (ICU) Other Locations (Not NICU or SCA) No Health Health Care Services
57.118 Denominators for ICU Yes Yes Fillable Fileable Form 57.118_DenominatorICU_BLANK.DOCX
Private Sector 324000 1620000 50997600

57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring No Health Health Care Services
57.127 MDRO and CDI Prevention Process and Outcome Measures Monitoring Yes Yes Fillable Fileable Form 57.127_MDROMonthlyReporting_BLANK.DOCX
Private Sector 144000 28800 1089792

57.503 Denominators for Outpatient Dialysis No Health Health Care Services
57.503 Denominator for Outpatient Dialysis Yes Yes Fillable Fileable Form 57.503_DenomOutpatDialysis_BLANK.DOCX
Private Sector 72000 7200 226656

57.126 MDRO or CDI Infection Event No Health Health Care Services
57.126 MDRO or CDI Infection Event Yes Yes Fillable Fileable Form 57.126_MDROInfectionEvent_BLANK.DOCX
Private Sector 432000 208800 7900992

57.120 Surgical Site Infection (SSI) No Health Health Care Services
57.120 Surgical Site Infection Yes Yes Fillable Fileable Form 57.120_SSI_BLANK.DOCX
Private Sector 216000 104400 3950496

57.128 Laboratory Identified or CDI MDRO Event No Health Health Care Services
57.128 Lab Identified MDRO or CDI Event Yes Yes Fillable Fileable Form 57.128_LabIDEvent_BLANK.DOCX
Private Sector 1440000 360000 13622400

57.121 Denominators for Procedure No Health Health Care Services
57.121 Denominator for Procedure Yes Yes Fillable Fileable Form 57.121_DenomProc_BLANK.DOCX
Private Sector 3240000 270000 8499600

57.100 NHSN Registration Form No Health Health Care Services
57.100 NHSN Registration Yes No Fillable Printable Form 57.100_RegistrationForm_BLANK.DOCX
Private Sector 2000 167 6307

57.123 Antimicrobial Use and Resistance (AUR) - Microbiology Data Upload Tables No Health Health Care Services
57.123 Antimicrobial Use and Resistance Micro Upload Tables Yes Yes Fillable Fileable Form 57.123_AUR Micro Electronic Upload Tables.docx
Private Sector 72000 6000 107400

57.130 Vaccination Monthly Monitoring Form - Summary Method No Health Health Care Services
57.130 Vaccination Monthly Monitoring - Summary Method Yes Yes Fillable Fileable Form 57.130_VaccMonthlyReportingSummary_BLANK.DOCX
Private Sector 500 7000 264880

57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data No Health Health Care Services
57.124 Antimicrobial Use and Resistance - Pharm Data Upload Tables Yes Yes Fillable Fileable Form and instruction 57.124_AUR Pharm Electronic Upload Tables.docx
Private Sector 72000 6000 84600

57.133 Patient Vaccination No Health Health Care Services
57.133 Patient Vaccination Yes Yes Fillable Fileable Form 57.133_PtVacc_BLANK.DOCX
Private Sector 25000 4167 157667

57.101 Facility Contact Information No Health Health Care Services
57.101 Facility Contact Information Yes No Fillable Printable Form 57.101_FacConInf_BLANK.DOCX
Private Sector 2000 333 12613

57.131 Vaccination Monthly Monitoring Form - Patient-Level Method No Health Health Care Services
57.131 Vaccination Monthly Monitoring - Patient level Yes Yes Fillable Fileable Form 57.131_VaccMonthlyReportingPatient_BLANK.DOCX
Private Sector 500 1000 37840

57.103 Patient Safety Component - Annual Hospital Survey No Health Health Care Services
57.103 Patient Safety - Annual Hospital Survey Yes No Fillable Printable Form 57.103_PSHospSurv_BLANK.DOCX
Private Sector 6000 3000 113520

57.140 Urinary Tract Infection (UTI) for LTCF No Health Health Care Services
57.140 Urinary Tract Infection for LTCF Yes Yes Fillable Fileable Form 57.140_UTI_LTCF_BLANK.DOCX
Private Sector 2250 1013 38313

57.105 Group Contact Information No Health Public Health Monitoring
57.105 Group Contact Information Yes Yes Fillable Fileable Form 57.105_GrpContact_BLANK.DOCX
Private Sector 6000 500 18920

57.205 Exposure to Blood and Body Fluids No Health Health Care Services
57.205 Exposure to Blood/Body Fluids Yes Yes Fillable Fileable Form 57.205_ExpBBF_BLANK.DOCX
Private Sector 2500 2500 99625

57.206 Healthcare Worker Prophylaxis/Treatment No Health Health Care Services
57.206 Healthcare Worker Prophylaxis/Treatment Yes Yes Fillable Fileable Form 57.206_HCWPEP_BLANK.DOCX
Private Sector 1500 375 14944

57.204 Healthcare Worker Demographic Data No Health Health Care Services
57.204 Healthcare Worker Demographic Data Yes Yes Fillable Fileable Form 57.204_HCWDemographicData_BLANK.DOCX
Private Sector 10000 3333 132833

57.200 Healthcare Personnel Safety Component Facility Survey No Health Health Care Services
57.200 Healthcare Personnel Safety - Annual Facility Survey Yes Yes Fillable Fileable Form 57.200_AnnualFacSurv_BLANK.DOCX
Private Sector 50 400 15940

57.300 Hemovigilance Module Annual Facility Survey No Health Health Care Services
57.300 Hemovigilance Module Annual Survey Yes Yes Fillable Fileable Form 57.300_HV Annual Facility Survey_BLANK.DOCX
Private Sector 500 1000 33140

57.301 Hemovigilance Module Monthly Reporting Plan No Health Health Care Services
57.301 Hemovigilance Module Monthly Reporting Plan Yes Yes Fillable Fileable Form 57.301_HV Monthly Reporting Plan_BLANK.DOCX
Private Sector 6000 100 3314

57.302 Hemovigilance Module Monthly Incident Summary No Health Public Health Monitoring Private Sector 0 0 0

57.303 Hemovigilance Module Monthly Reporting Denominators No Health Health Care Services
57.303 Hemovigilance Module Monthly Reporting Denominators Yes Yes Fillable Fileable Form 57.303_HV Monthly Reporting Denoms_BLANK.DOCX
Private Sector 6000 6000 198840

57.305 Hemovigilance Incident No Health Health Care Services
57.305 Hemovigilance Incident Yes Yes Fillable Fileable Form 57.305_HV Incident_BLANK.DOCX
Private Sector 6000 1000 33140

57.304 Hemovigilance Module Adverse Reaction No Health Health Care Services
57.304 Hemovigilance Adverse Reaction Yes Yes Fillable Fileable Form 57.304_HV Adverse Reaction_BLANK.DOCX
Private Sector 24000 6000 198840

57.137 Long Term care Facility Component--Annual Facility Survey No Health Health Care Services
57.137 Long Term Care Facility - Annual Survey Yes Yes Fillable Fileable Form 57.137_LTCFSurv_BLANK.DOCX
Private Sector 250 188 7095

57.138 Laboratory-Identified MDRO or CDI Event for LTCF No Health Health Care Services
57.138 Lab-identified MDRO or CDI Event Yes Yes Fillable Fileable Form 57.138_LabIDEvent_LTCF_BLANK.DOCX
Private Sector 2000 500 18920

57.139 MDRO and CDI Monthly Monitoring for LTCF No Health Health Care Services
57.139 MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF Yes Yes Fillable Fileable Form 57.139_MDROMonthlyReporting_LTCF_BLANK.DOCX
Private Sector 3000 250 9460

57.112 Ventilator-Associated Event (VAE) No Health Health Care Services
57.112 Ventilator-associated Event Yes Yes Fillable Fileable Form 57.112_VAE_BLANK.DOCX
Private Sector 864000 316800 11987712

57.141 Monthly Reporting Plan for LTCF No Health Health Care Services
57.141 Monthly Reporting Plan for LTCF Yes Yes Fillable Fileable Form 57.141_ReportPlan_LTCF_BLANK.DOCX
Private Sector 3000 250 9460

57.142 Denominators for LTCF Locations No Health Health Care Services
57.142 Denominators for LTCF Locations Yes Yes Fillable Fileable Form 57.142_DenominatorLTCF_BLANK.DOCX
Private Sector 3000 9000 340560

57.143 Prevention Process Measures Monthly Monitoring for LTCF No Health Health Care Services
57.143 Prevention Process Measures Monthly Monitoring Yes Yes Fillable Fileable Form 57.143_ProcessMeasureSummaryforLTCF_BLANK.DOCX
Private Sector 3000 250 9460

57.150 Patient Safety Component -- Annual Facility Survey for LTAC No Health Health Care Services
57.150 LTAC Annual Survey Yes Yes Fillable Fileable Form 57.150_LTACFacSurv_BLANK.DOCX
Private Sector 400 200 7568

57.151 Patient Safety Component -- Annual Facility Survey for IRF No Health Health Care Services
57.151 Rehab Annual Survey Yes Yes Fillable Fileable Form 57.151_REHABFacSurv_BLANK.DOCX
Private Sector 1000 417 15767

57.400 Outpatient Procedure - Annual Facility Survey No Health Health Care Services
57.400 Outpatient Procedure - Annual Facility Survey Yes Yes Fillable Fileable Form 57.400_OPCFacSurv_BLANK.DOCX
Private Sector 5000 417 13117

57.401 Outpatient Procedure - Monthly Reporting Plan No Health Health Care Services
57.401 Outpatient Procedure - Monthly Reporting Plan Yes Yes Fillable Fileable Form 57.401_OPCReportPlan_BLANK.DOCX
Private Sector 60000 15000 472200

57.402 Outpatient Procedure - Event No Health Health Care Services
57.402 Outpatient Procedure - Event Yes Yes Fillable Fileable Form 57.402_OPCEvent_BLANK.DOCX
Private Sector 125000 83333 2623333

57.403 Outpatient Procedure - Monthly Denominators and Summary No Health Health Care Services
57.403 Outpatient Procedure - Monthly Denominators and Summary Yes Yes Fillable Fileable Form 57.403_OPCDenom_BLANK.DOCX
Private Sector 60000 40000 1259200

57.501 Dialysis Monthly Reporting Plan No Health Health Care Services
57.501 Dialysis Monthly Reporting Plan Yes Yes Fillable Fileable Form 57.501_DialReportPlan_BLANK.DOCX
Private Sector 72000 6000 188880

57.504 Prevention Process Measures Monthly Monitoring for Dialysis No Health Health Care Services
57.504 Prevention Process Measures Monthly Monitoring for Dialysis Yes Yes Fillable Fileable Form 57.504_ProcessMeasureSummaryforDIAL_BLANK.DOCX
Private Sector 7200 3600 113328

57.505 Dialysis Patient Influenza Vaccination No Health Health Care Services
57.505 Dialysis Patient Influenza Vaccination Yes Yes Fillable Fileable Form 57.505_Dialysis Patient Flu Vac_BLANK.DOCX
Private Sector 18750 3125 98375

57.506 Dialysis Patient Influenza Vaccination Denominator No Health Health Care Services
57.506 Dialysis Patient Influenza Vaccination Denominator Yes Yes Fillable Fileable Form 57.506_Dialysis Patient Flu Vac Denom_BLANK.DOCX
Private Sector 1250 208 6558

57.600 State Health Department Validation Record No Health Health Care Services
57.600 State Health Department Validation Record Yes Yes Fillable Fileable Form 57.600_State HD Validation Record_BLANK.DOCX
State, Local, and Tribal Governments 7600 1900 59622

2013-10-30-04:00

0920-0679 201103-0920-002 0920
             
        "Division for Heart Disease and Stroke Prevention Management Infromation System (formerly titled:  Cardiovascular Health Branch Management Information System)"
             
          
        
This Revision ICR supports continued collection of progress and activity information from health departments in selected states and the District of Columbia. Respondents are funded through the National Heart Disease and Stroke Prevention Program. Information collected through the electronic MIS is used to monitor and evaluate programs, and to provide technical assistance to NHDSPP awardees. 2014-04-30-04:00 Active Petunia Gissendaner 4046390164 No No No 84 504 0

Heart Disease and Stroke Prevention Programs No Health Illness Prevention
1 DHDSP MIS SCREEN SHOTS Yes Yes Fillable Fileable Form and instruction Attachment 4. DHDSP MIS Screen Shots.docx No No Fillable Printable Other Attachment 6. Proposed Revisions.doc No No Fillable Printable Other CHB MIS Data Collection Tool.doc
State, Local, and Tribal Governments 84 504 0

WISEWOMAN Programs No Health Public Health Monitoring State, Local, and Tribal Governments 0 0 0

2011-04-08-04:00

0920-0696 201301-0920-009 0920
             
        "National HIV Prevention Program Monitoring and Evaluation (NHM&E) "
             
          
        
CDC is requesting approval for a 3 year REVISION of a previously approved project. The initial PEMS OMB request was approved in 2005, for one year; reinstated 2007, for three years; and revised 2010 for three years. The purpose of this revision is to continue collecting standardized HIV prevention program evaluation data from health departments and community-based organizations (CBOs) who receive federal funds for HIVE prevention activities. The previous reporting system PEMS has been replaced by a more efficient reporting software National HIV Prevention Program Monitoring and Evaluation (NHM&E). 2016-03-31-04:00 Active Thelma Sims 4046394771 No No No 1338 206226 0

Health Department Data No Health Public Health Monitoring State, Local, and Tribal Governments 138 190026 0

Community-Based Organizations - Agency Data No Health Public Health Monitoring Private Sector 400 200 0

Community Based Organization HE/RR Data No Health Public Health Monitoring State, Local, and Tribal Governments 400 8000 0

PEMS Data Collection for Health Jurisdictions (HIV testing non-scan) No Health Public Health Monitoring
none NHM&E variables Yes Yes Fillable Fileable Form Attachment 5 NHME Variables and Values.pdf
State, Local, and Tribal Governments 0 0 0

Counseling, Testing and Referral for Community-Based Organizations No Health Public Health Monitoring
none HIV test form - Pacific Islands Yes Yes Fillable Fileable Form and instruction Attachment 3 C Pacific Islands HIV Test Form.pdf none HIV test form - page 3 Yes Yes Fillable Fileable Form and instruction Attachment 3 B HIV Test Form Page 3.pdf none HIV test form - page 2 Yes Yes Fillable Fileable Form and instruction Attachment 3 B HIV Test Form Page 2.pdf none HIV test form - page 1 Yes Yes Fillable Fileable Form and instruction Attachment 3 B HIV Test form Page 1.pdf
Private Sector 0 0 0

PEMS Data Collection for Health Jurisdictions (Training) No Health Public Health Monitoring
none NHM&E variables Yes Yes Fillable Fileable Form Attachment 5 NHME Variables and Values.pdf
State, Local, and Tribal Governments 0 0 0

PEMS Data Collection for Community-Based Organizations (Training) No Health Public Health Monitoring
none NHM&E variables Yes Yes Fillable Fileable Form Attachment 5 NHME Variables and Values.pdf
Private Sector 0 0 0

Community Based Organizations: NH&E Data Training No Health Public Health Monitoring State, Local, and Tribal Governments 400 8000 0

2013-03-20-04:00

0920-0706 201304-0920-015 0920
             
        "National Program of Cancer Registries Program Evaluation Instrument "
             
          
        
CDC provides funding to 48 central cancer registries through the National Program of Cancer Registries (NPCR). Awardees prepare progress and activity reports that allow CDC to monitor their performance and adherence to NPCR program standards. Reports are submitted electronically to CDC every other year. 2016-05-31-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 32 64 0

NPCR - Program Evaluation Instrument (NPCR-PEI) No Health Immunization Management
none NPCR Program Evaluation Yes Yes Fillable Fileable Form Att 3A_0706_PEI Instrument Screenshots_2013.docx
State, Local, and Tribal Governments 32 64 0

2013-05-22-04:00

0920-0728 201311-0920-015 0920
             
        "National Notifiable Diseases Surveillance System (NNDSS)"
             
          
        
In effort to develop a more coordinated and integrated infectious diseases surveillance system, the Centers for Disease Control and prevention requests approval to consolidate collections under the National Notifiable Diseases Surveillance system (NNDSS). 2017-01-31-05:00 Active Carol Marsh cww6@cdc.gov 404 639-4773 No No No 2964 28340 0

The National Electronic Disease Surveillance System City and State Weekly Reporting No Health Public Health Monitoring
Yes Yes Printable Only Instruction ATT- 6 Copy of MASTER Legacy to NEDSS Spreadsheet.xls Yes Yes Printable Only Instruction ATT- 1A Lead Case Notification Message Mapping Guide 05172007.xls Yes Yes Fillable Printable Instruction ATT- 10 NETSS Format Case Record Specifications.doc Yes Yes Fillable Printable Instruction ATT- 1C Lead Lab Report Notification Message Mapping Guide 05172007.xls none Case notification message mapping guide Yes Yes Fillable Fileable Form and instruction ATT- 8 Copy of Generic_Case_Notification_Message_Mapping_Guide_v.1.xls Yes Yes Fillable Printable Instruction ATT- 1E Varicella Notification Message Mapping Guide 06052007.xls Yes Yes Printable Only Instruction ATT-_1F_Hepatitis_Notification_Message_Mapping_Guide_06202007.xls Yes Yes Fillable Printable Instruction ATT- 1B Lead Environmental Notification Message Mapping Guide 05172007.xls
State, Local, and Tribal Governments 0 0 0

The National Electronic Disease Surveillance System Territories Weekly Reporting No Health Public Health Monitoring
Yes Yes Fillable Printable Instruction ATT- 1B Lead Environmental Notification Message Mapping Guide 05172007.xls none Case notification message mapping guide Yes Yes Fillable Printable Form and instruction ATT- 8 Copy of Generic_Case_Notification_Message_Mapping_Guide_v.1.xls Yes Yes Fillable Printable Instruction ATT- 1C Lead Lab Report Notification Message Mapping Guide 05172007.xls Yes Yes Fillable Printable Instruction ATT- 1E Varicella Notification Message Mapping Guide 06052007.xls Yes Yes Fillable Printable Instruction ATT- 10 NETSS Format Case Record Specifications.doc Yes Yes Fillable Printable Instruction ATT-_1F_Hepatitis_Notification_Message_Mapping_Guide_06202007.xls Yes Yes Printable Only Instruction ATT- 1A Lead Case Notification Message Mapping Guide 05172007.xls Yes Yes Printable Only Instruction ATT- 6 Copy of MASTER Legacy to NEDSS Spreadsheet.xls
State, Local, and Tribal Governments 0 0 0

The National Electronic Disease Surveillance System (NEDSS) Annual Reporting States and Cities No Health Public Health Monitoring
Yes Yes Fillable Printable Instruction ATT- 1E Varicella Notification Message Mapping Guide 06052007.xls Yes Yes Fillable Printable Instruction ATT-_1F_Hepatitis_Notification_Message_Mapping_Guide_06202007.xls Yes Yes Printable Only Instruction ATT- 6 Copy of MASTER Legacy to NEDSS Spreadsheet.xls Yes Yes Printable Only Instruction ATT- 1A Lead Case Notification Message Mapping Guide 05172007.xls Yes Yes Fillable Printable Instruction ATT- 1B Lead Environmental Notification Message Mapping Guide 05172007.xls Yes Yes Fillable Printable Instruction ATT- 1C Lead Lab Report Notification Message Mapping Guide 05172007.xls none Case notification message mapping guide Yes Yes Fillable Printable Form and instruction ATT- 8 Copy of Generic_Case_Notification_Message_Mapping_Guide_v.1.xls Yes Yes Fillable Printable Instruction ATT- 10 NETSS Format Case Record Specifications.doc
State, Local, and Tribal Governments 0 0 0

The National Electronic Disease Surveillance System (NEDSS) Territories Annual Reporting No Health Public Health Monitoring
Yes Yes Printable Only Instruction ATT- 6 Copy of MASTER Legacy to NEDSS Spreadsheet.xls Yes Yes Fillable Printable Instruction ATT-_1F_Hepatitis_Notification_Message_Mapping_Guide_06202007.xls Yes Yes Fillable Printable Instruction ATT- 1B Lead Environmental Notification Message Mapping Guide 05172007.xls Yes Yes Fillable Printable Instruction ATT- 1C Lead Lab Report Notification Message Mapping Guide 05172007.xls Yes Yes Fillable Printable Instruction ATT- 1E Varicella Notification Message Mapping Guide 06052007.xls none Case notification message mapping guide Yes Yes Fillable Printable Form and instruction ATT- 8 Copy of Generic_Case_Notification_Message_Mapping_Guide_v.1.xls Yes Yes Printable Only Instruction ATT- 1A Lead Case Notification Message Mapping Guide 05172007.xls Yes Yes Fillable Printable Instruction ATT- 10 NETSS Format Case Record Specifications.doc
State, Local, and Tribal Governments 0 0 0

States - Reporting No Health Immunization Management State, Local, and Tribal Governments 2600 26000 0

Territories - Reporting No Health Immunization Management State, Local, and Tribal Governments 260 1300 0

Cities - Reporting No Health Immunization Management State, Local, and Tribal Governments 104 1040 0

2014-01-15-05:00

0920-0729 201102-0920-014 0920
             
        "Customer Surveys Generic Clearance for the National Center for Health Statistics"
             
          
        
This is a reinstatement request for a generic clearance to conduct customer surveys over the next 3 years. NCHS plans to continue to assess its cusotmers' satisfaction witht he content, quality, and relevance of the information it produces. 2014-04-30-04:00 Active Carol Walker 4046394773 No No No 8040 1640 0

Feedback Survey of Persons registered for the NCHS 2010 National Conference No Health Consumer Health and Safety
none Customer Satisfaction Website Survey Yes Yes Fillable Fileable Form NCHS 2011 Con SURVEY Att. B.mht none NCHS Feedback Survey Yes Yes Fillable Fileable Form NCHS 2011 cus sur Gen IC Attachment A 062211.docx
Private Sector 2000 267 0

Customer Satisfaction Survey for the Research Data Center No Health Immunization Management Private Sector 900 150 0

2011-04-21-04:00

0920-0733 201307-0920-002 0920
             
        "Early Hearing Detection and Intervention Hearing Screening and Follow-up survey"
             
          
        
This data collection is intended to target only state and territorial EHDI program directors. NCBDDD will utilize a revised survey to collect standardized annual state data related to the number of children screened for hearing loss, referred for and receiving follow-up testing (e.g., diagnostic audiologic evaluation). 2016-08-31-04:00 Active Petunia Gissendaner 4046390164 No No No 114 230 0

Early Hearing Detecton and Intervention Hearing Screening and Follow-up survey No Health Public Health Monitoring
None Screenshots for CDC EHDI Hearing Screening and Follow-up Survey (HSFS) Yes Yes Fillable Fileable Form and instruction Attach_4C_2013_screenshots_Rev.pdf None CDC EHDI Hearing Screening and Follow-up Survey (HSFS) Yes Yes Fillable Fileable Form and instruction Attach_4B_HSFS_2013.docx
State, Local, and Tribal Governments 55 220 0

CDC EHDI Hearing Screening and Followup Survey (HSFS) No Health Public Health Monitoring
2 CDC EHDI Hearing Screening and Follow-up Survey (HSFS) Yes Yes Fillable Fileable Form Attach_4B_EHDI_Survey.docx Yes Yes Fillable Fileable Instruction Attach_4A_Directions_for_EHDI_Survey.docx
State, Local, and Tribal Governments 0 0 0

Survey Directions No Health Health Care Services State, Local, and Tribal Governments 59 10 0

2013-08-14-04:00

0920-0739 201303-0920-008 0920
             
        "CDC Oral Health Management Information System"
             
          
        
CDC provides funds to oral health programs in states and territories to support oral health infrastructure and develop programs. Progress and performance information is collected from awardees to monitor and improve program performance. Information is collected through a web-based MIS. 2014-04-30-04:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 20 220 0

CDC Oral Health Management Information System - MOLAR MIS No Health Immunization Management
none MOLAR MIS Yes Yes Fillable Fileable Form Attachment 3. MOLAR MIS screen shots.pdf
State, Local, and Tribal Governments 20 220 0

2013-04-11-04:00

0920-0740 201311-0920-014 0920
             
        "Medical Monitoring Project"
             
          
        
This request is to make minor changes to the questionnaire with no change in burden or respondents. 2015-05-31-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 20126 8537 0

Patients Standard Interview No Health Public Health Monitoring
None 2014 Standard Questionnaire for Medical Monitoring Project (MMP) Yes Yes Fillable Fileable Form MMP 2014 interview v10.0.2 clean.docx
Individuals or Households 7219 5414 0

Patient Short interview No Health Public Health Monitoring
none Standard Interview Yes Yes Fillable Fileable Form MMP 2013 Interview v.9.5.0_Clean.docx
Individuals or Households 301 100 0

Facility Staff Medical Record Abstraction No Health Public Health Monitoring State, Local, and Tribal Governments 7520 376 0

Facility staff Providing Estimated Patient Loads No Health Public Health Monitoring State, Local, and Tribal Governments 936 1872 0

Providing Patient Lists for Medical Monitoring Project Patient Sampling No Health Public Health Monitoring Individuals or Households 1030 515 0

Approaching Sampled Patients for Enrollment No Health Public Health Monitoring Individuals or Households 3120 260 0

2013-11-25-05:00

0920-0743 201308-0920-008 0920
             
        "Assessment & Monitoring of Breastfeeding-Related Maternity Care Practices in Intrapartum Care Facilities in the United States and Territories"
             
          
        
CDC plans to conduct a census survey of all intra-partum care facilities in the U.S. and territories about the facilities' maternity care practices focused on care and support for breastfeeding throughout the maternity stay. This ICR requests administration of two iterations of the survey (in 2013 and 2015) spanning the requested three-year ICR approval period using methodology similar to that established and carried out in previous surveys conducted in 2007, 2009, and 2011. 2016-09-30-04:00 Active Thelma Sims 4046394771 No No No 6595 1103 0

Screening Telephone Call Script_Part A (all respondents) No Health Health Care Services Private Sector 2570 43 0

mPINC (National Survey of Maternity Practices in Infant Nutrition and Care) Survey (for ALL facilities) No Health Health Care Services Private Sector 1825 913 0

Screening Telephone Call Script -- Part B (eligibles only) No Health Health Care Services Private Sector 2200 147 0

2011 mPINC Survey for Birth Centers No Health Public Health Monitoring
none Birth Center Survey Yes Yes Fillable Fileable Form App H-2_2011 mPINC Survey for Birth Centers REVISED 5 27 2011.docx
Private Sector 0 0 0

2013-09-23-04:00

0920-0745 201304-0920-004 0920
             
        "Colorectal Cancer Screening Program"
             
          
        
CDC funds 29 cooperative agreement awardees to increase population-based colorectal cancer (CRC) screening and to reduce health disparities in CRC screening, incidence and mortality. CDC collects programmatic-level activity cost data and de-identified patient-level demographic, screening, diagnostic, treatment and outcome data. An Extension for three years is requested. 2016-04-30-04:00 Active Carol Walker 4046394773 No No No 10904 3357 0

Clinical Data Elements (CCDE) No Health Illness Prevention State, Local, and Tribal Governments 10875 2719 0

Cost Assessment Tool No Health Health Care Services State, Local, and Tribal Governments 29 638 0

2013-04-29-04:00

0920-0765 201302-0920-017 0920
             
        "Fellowship Management System"
             
          
        
The Fellowship Management System (FMS)is a robust flexible framework that has been tailored for variouos CDC fellowships, including the Public Health Prevention Service (PHPS). CDC requests modifications to the(PHPS) host site. 2015-02-28-05:00 Active Carol Walker 4046394773 No No No 1802 1258 0

Fellowship Management System - applicants No Workforce Management Training and Employment Individuals or Households 1122 748 0

Fellowship alumni - Fellowship Management System No Workforce Management Training and Employment Individuals or Households 454 114 0

Public Health Agency or Organization No Workforce Management Training and Employment State, Local, and Tribal Governments 226 396 0

2013-03-07-05:00

0920-0768 201103-0920-005 0920
             
        "Outcomes Data Collection of the National Prevention Information Network "
             
          
        
The National Center for HIV, Viral Hepatitis, STD and TB Prevention (NCHHSTP) within the Centers for Disease Control and Prevention (CDC)proposes a revision of a survey data collection to assess the CDC National Prevention Information Network's (NPIN) website, products and services. The CDC NPIN serves as the U.S. reference, referral, and distribution services for information on HIV/AIDS, STD, TB and Viral Hepatitis. Products and services offered by the CDC NIP website is the primary channel used by the CDC to provide information concerning prevention, treatment and care of HIV, STD, TB and viral Hepatitis to its prevention partners, stakeholders, and other constituents. 2014-04-30-04:00 Active Carol Walker 4046394773 No No No 1500 342 0

Outcomes Data Collection of the National Prevention Information Network NPIN Website User Survey No Health Consumer Health and Safety
none NPIN Website User Survey Yes Yes Fillable Fileable Form 0920_0768_2010_NPIN_att3-B_WebSiteSurvey.doc
Private Sector 500 125 0

Outcomes Data Collection of the National Prevention Information Network NPIN Products and Services User Survey Private Sector Organizations No Health Illness Prevention
none NPIN Products and Services User Survey No Yes Fillable Fileable Form 0920_0768_2010_NPIN_att3-D_ProdServiceSurvey.doc
Private Sector 1000 217 0

Outcomes Data Collection of the National Prevention Information Network Product and Services Users Survey- State and Local Government No Health Illness Prevention State, Local, and Tribal Governments 0 0 0

Outcomes Data Collection of the National Prevention Information Network NPIN Products and Services User Survey Federal Government Organization No Health Illness Prevention Federal Government 0 0 0

Outcomes Data Collection of the National Prevention Information Network NPIN Product and Services User Survey Individual/Household No Health Illness Prevention Individuals or Households 0 0 0

Outcomes Data Collection of the National Prevention Information Network NPIN Products and Services User Survey (Telephone) Private Sector Organization No Health Illness Prevention Private Sector 0 0 0

Outcomes Data Collection of the National Prevention Information Network Products and Services Users Survey (Telephone) State and Local Govt No Health Illness Prevention State, Local, and Tribal Governments 0 0 0

Outcomes Data Collection of the National Prevention Information Network (Telephone) Survey Federal Government Organization No Health Illness Prevention Federal Government 0 0 0

Outcomes Data Collection of the National Prevention Information Network NPIN Products and Servcies User Survey (Telephone) Individual/Households No Health Illness Prevention Individuals or Households 0 0 0

2011-04-25-04:00

0920-0770 201112-0920-012 0920
             
        "National HIV Behavioral Surveillance System"
             
          
        
This is a change request to submit a revised questionnaire to improve understandability and responses. 2014-05-31-04:00 Active Daniel Holcomb dwh6@cdc.gov 770 488-4472 No No No 31668 9932 0

NHBS Screening (All Respondent Groups) No Health Public Health Monitoring
0920-0770 Attachment 3a Yes Yes Fillable Printable Form and instruction 0920-0770_Att 3a_Eligibility Screener_Spanish.pdf 0920-0770 Attachment 2A Yes Yes Fillable Printable Form and instruction 0920-0770_Att 2a_Eligibility Screener_Eng.pdf
Individuals or Households 15000 1250 0

NHBS Behavioral Assessment (MSM) No Health Public Health Monitoring
0920-0770 Attachment 2b Yes Yes Fillable Printable Form and instruction 0920-0770_Att 2b_Behavioral Assessment_MSM_Eng.pdf 0920-0770 Attachment 3b Behavioral Assessment (MSM) Spanish version Yes Yes Fillable Printable Form and instruction 0920-0770_Att 3b_Behavioral Assessment_MSM_Spanish.pdf
Individuals or Households 4167 2084 0

NHBS Recruiter Debriefing No Health Public Health Monitoring
0920-0770 Attachment 2e Recruiter Debriefing English version Yes Yes Fillable Printable Form and instruction 0920-0770_Att 2e_Recruiter_Debrief_Eng.pdf 0920-0770 Attachment 3e Recruiter Debrief Spanish version Yes Yes Fillable Printable Form and instruction 0920-0770_Att 3e_Recruiter_Debrief_Spanish.pdf
Individuals or Households 4167 139 0

NHBS Behavioral Assessment (IDU) No Health Public Health Monitoring
0920-0770 Attachment 3c Behavioral Assessment (IDU) Spanish version Yes Yes Fillable Printable Form and instruction 0920-0770_Att 3c_Behavioral Assessment_IDU_Spanish.pdf 0920-0770 Attachment 2c Behavioral Assessment (IDU) English version Yes Yes Fillable Printable Form and instruction 0920-0770_Att 2c_Behavioral Assessment_IDU_Eng.pdf
Individuals or Households 4167 3750 0

NHBS Behavioral Assessment Survey (HET) No Health Public Health Monitoring
0920-0770 Attachment 2d Behavioral Assessment (HET) English version Yes Yes Fillable Printable Form and instruction 0920-0770_Att 2d_Behavioral Assessment_HET_Eng (2).pdf 0920-0770 Attachment 3d Behavioral Assessment (HET) Spanish version Yes Yes Fillable Printable Form and instruction 0920-0770_Att 3d_Behavioral Assessment_HET_Spanish.pdf
Individuals or Households 4167 2709 0

2011-12-21-05:00

0920-0773 201110-0920-006 0920
             
        "National Surveillance for Severe Adverse Events Associated with Treatment of Latent Tuberculosis Infection"
             
          
        
Since approval of the NSSAE collection form 3 years ago, the project officers published the article Severe Isoniazid-associated Liver Injuries Among persons Being Treated for Latent Tuberculosis Infection--- United States, 2004--2008, Morbidity and Mortality Report , 2010. In this article, the project officers described 17 reports of severe adverse events (SAEs) in 15 adults and two children; all patients had received isoniazid (INH) and had experienced severe liver injury. This article emphasized that healthcare providers should prescribe only 1-month supply of INH with careful monitoring. Providers should report possible INH-associated SAEs to their respective health department staff who will in turn report to CDC. The project officers also have presented these SAEs to national and international audiences at scientific conferences. There has been an increase in the number of SAE reports. Since 2008, project officers received an additional 25 SAE reports and investigated 5 of these on site. A better understanding of the data needed to accurately capture important elements describing factors that led to these events and as a result, the NSSAE data collection form has been shortened into four pages instead of the original 6 pages. 2014-11-30-05:00 Active Catina Conner 4046394775 No No No 30 60 0

Adverse Events LBTI NSSAE - Physicians No Health Consumer Health and Safety State, Local, and Tribal Governments 10 10 0

Adverse Events to LTBI Treatment (AELT) NSSAE - Nurses No Health Consumer Health and Safety State, Local, and Tribal Governments 10 40 0

Adverse Events to LTBI Treatment (AELT) NSSAE - Clerk No Health Consumer Health and Safety State, Local, and Tribal Governments 10 10 0

2011-11-17-05:00

0920-0775 201104-0920-002 0920
             
        "Formative Research to Develop Social Marketing Campaigns-Routine HIV Testing For Emergency Medicine Physicians, Prevention Is Care, and Partner Services"
             
          
        
This project involves formative research to inform the development of 3 CDC-sponsored social marketing campaigns: 1) Social Marketing Campaigns to Make HIV Testing a Routine Part of Medical Care for Emergency Medicine Physicians (Routine HIV Testing); 2) Prevention Is Care (PIC); and 3) Partner Services (Partner Services). Activities include conducting interviews to test creative materials with groups of emergency medicine physicians for Routine HIV Testing and, PCP and Infectious Disease Specialists for PIC and Partner Services. 2014-05-31-04:00 Active Carol Walker 4046394773 No No No 293 117 0

Emergency Departments Material Testing Interview No Health Health Care Services
none Emergency Department HIV Testing Interview No No Paper Only Form A2a Data Collection Instruments-Routine Testing.docx
Individuals or Households 8 8 0

Prevention Is Care (PIC) Material Testing Interview No Health Health Care Services
none Prevention is Care Interview No No Paper Only Form A2b Data Collection Instruments-PIC.docx
Individuals or Households 48 48 0

HIV Partner Services Exploratory Research No Health Illness Prevention Individuals or Households 0 0 0

HIV Partner Services Concept Testing Interview No Health Health Care Services
none Partner Services - Concept Testing Interview No No Paper Only Form A2c Data Collection Instruments-Partner Services-concept.docx
Individuals or Households 13 13 0

HIV Partner Services Material Testing Interview No Health Health Care Services
none Partner Services - Material Testing Interview No No Paper Only Form A2d Data Collection Instruments-Partner Services-materials.docx
Individuals or Households 13 13 0

Emergency Departments Study Screener No Health Health Care Services
none Emergency Dept. Routine HIV Testing Screener Yes No Fillable Fileable Form A6a Screening Instruments-Routine Testing.docx
Individuals or Households 12 2 0

Partner Services Study Screener No Health Illness Prevention
none Patner Services Screener Yes No Fillable Printable Form A6c Screening Instruments-Partner Services.docx
Individuals or Households 39 7 0

Prevention Is Care (PIC) Study Screener No Health Illness Prevention
none Prevention is Care Screener Yes No Fillable Printable Form A6b Screening Instruments-PIC.docx
Individuals or Households 72 12 0

Emergency Departments Paper and Pencil Questionnaire No Health Health Care Services
none Emergency Dept Paper and Pencil Questionnaire No No Paper Only Form A7a Paper and Pencil Survey-Routine Testing.docx
Individuals or Households 8 1 0

Prevention Is Care (PIC) Paper and Pencil Questionnaire No Health Illness Prevention
none PIC Paper and Pencil Questionnaire No No Paper Only Form A7b Paper and Pencil Survey-PIC.docx
Individuals or Households 54 9 0

Partner Services Paper and Pencil Questionnaire No Health Health Care Services
none Partner Services Paper and Pencil Questionnaire No No Paper Only Form A7c Paper and Pencil Survey-Partner Services.docx
Individuals or Households 26 4 0

2011-05-10-04:00

0920-0792 201109-0920-005 0920
             
        "Environmental Health Specialists Network (EHS-NET) Program"
             
          
        
The purpose of this food safety research program is to identify and understand environmental factors associated with foodborne illness and outbreaks. This program will involve up to 3 data collections a year, conducted by the EHS-Network, a collaborative project of CDC, FDA, USDA, and 6 state/local sites. 2015-02-28-05:00 Active Daniel Holcomb dwh6@cdc.gov 770 488-4472 No No No 31473 7407 0

EHS-Net Listeria Retail Deli Study No Health Immunization Management
none Worker Recruitment Script No No Paper Only Form and instruction Att. 6-EHS-Net Listeria-Worker Recruit Scrpt Inf Cnsnt 20121024.doc none Worker Interview No No Paper Only Form and instruction Att. 7-EHS-Net Listeria-Worker Interview 20121024.doc none Manager Consent and Interview No No Paper Only Form and instruction Att. 4-EHS-Net Listeria-Manager Inf Cnsnt Intrvw 20121024.doc none Manager Recruitment Script No No Paper Only Form and instruction Att. 11-EHS-Net Listeria-Manager Tel Recruit Scrpt 20121024.doc none Manager Survey No No Paper Only Form Att. 5-EHS-Net Listeria-Manager Survey 20121024.doc
Private Sector 1663 249 0

Food Allergen Study No Health Immunization Management
none Worker Interview No No Paper Only Form Att 4- Worker Rcrtg Script Informed Consent and Interview 9-23-2103.docx none Server Interview No No Paper Only Form Att 5- Server Rcrtg Script Informed Consent and Interview 9-23-2013.docx none Manager Interview No No Paper Only Form Att 3- Mgr Informed Consent and Interview 9-23-2013.docx none Manager Recruitment No No Paper Only Form Att 8- Mgr Rcrtg Script 9-24-2013.docx
Private Sector 1329 242 0

2012-02-06-05:00

0920-0800 201111-0920-004 0920
             
        "Focus Group Testing to Effectively Plan and Tailor Cancer Prevention and Control Communication Campaigns--New"
             
          
        
CDC's Division of Cancer Prevention and Control requests OMB approval for a generic clearance to conduct formative evaluation efforts in order to effectively plan new and/or tailor existing cancer communication campaigns. Information will be collected through focus group discussions involving the general public and health care professionals. Proposed activities will utilize HHS Health Communication Process methodology. 2014-11-30-05:00 Active Thelma Sims 4046394771 No No No 2592 1814 52843 2011-11-28-05:00

0920-0805 201202-0920-001 0920
             
        "Racial and Ethnic Approaches to Community Health across the U.S. (REACH U.S.) Evaluation"
             
          
        
CDC requests OMB approval to collect two additional years of health risk factor information from a random sample of adults in 28 REACH US communities (900 individuals per community). Results will be used to evaluate the REACH US program and to monitor health trends in racial and ethnic minority populations. 2015-03-31-04:00 Active Petunia Gissendaner 4046390164 No No No 49600 9460 0

Screening Interview No Health Public Health Monitoring
1 Household Screening Interview for Telephone Interviewing Yes Yes Fillable Printable Form Attachment 2a. Household Screening Interview.doc
Individuals or Households 14700 735 0

Risk Factor Surveys (Interview and SAQ) No Health Public Health Monitoring
2 Household Member Interview for Telephone Interviewing Yes Yes Fillable Fileable Form and instruction Attachment 2b. Household Member Interview.doc 3 Reach U.S. Study Booklet Yes Yes Fillable Fileable Form and instruction Attachment 2c. SAQ.pdf
Individuals or Households 34900 8725 0

2012-03-02-05:00

0920-0819 201211-0920-010 0920
             
        "Nationally Notifiable Sexually Transmitted Disease (STD) Morbidity Surveillance"
             
          
        
The CDC is responsible for the reporting and dissemination of nationally notifiable STD morbidity information for prevention and control purposes in collaboration with state and local health departments. CDC is proposing to continue electronic information collection with a title change to "Nationally Notifiable Sexually Transmitted Disease (STD) Morbidity Surveillance", which will include information on laboratory confirmation of syphilis infection and risk behaviors of persons infected with syphilis and other STDs. The Nationally Notifiable Sexually Transmitted Disease (STD) Morbidity Surveillance data will identify population subgroups at increased risk for STDs, accommodate evidence-based intervention strategies, evaluate the impact of ongoing control efforts and generally enhance our understanding of STD transmission. 2016-02-29-05:00 Active Petunia Gissendaner 4046390164 No No No 2964 989 0

State Health Departments No Health Health Care Services
Yes Yes Fillable Printable Other ATT8_Data Screens from STDMIS 5.doc.docx no form number Information Content of Nationally STD Case Report by Data Element Yes Yes Fillable Printable Form and instruction ATT3_Data Elements.docx
State, Local, and Tribal Governments 2600 867 0

Territorial Health Agencies No Health Health Care Services
Yes Yes Fillable Printable Other ATT8_Data Screens from STDMIS 5.doc.docx no form number Information Content of Nationally STD Case Report by Data Element Yes Yes Fillable Printable Form and instruction ATT3_Data Elements.docx
State, Local, and Tribal Governments 260 87 0

City and County Health Departments No Health Health Care Services
Yes Yes Fillable Printable Other ATT8_Data Screens from STDMIS 5.doc.docx no form number Information Content of Nationally STD Case Report by Data Element Yes Yes Fillable Printable Form and instruction ATT3_Data Elements.docx
State, Local, and Tribal Governments 104 35 0

2013-02-01-05:00

0920-0821 201304-0920-005 0920
             
        "Quarantine Station Illness Response Forms: Airline, Maritime, and Land/Border Crossing"
             
          
        
Quarantine station staff work in partnership with international, federal, state, and local agencies and organizations to fulfill their mission to reduce morbidity and mortality among immigrants, refugees, travelers, expatriates, adn other globally mobile persons. 2015-08-31-04:00 Active Catina Conner 4046394775 No No No 3758 314 0

International Maritime Illness or Death Investigation No Health Public Health Monitoring
0920-0821 Attachment A Maritime investigation form Yes Yes Fillable Printable Form and instruction Attachment A Maritime investigation form_June22 2012.docx
Private Sector 1873 156 0

Land Travel Illness or Death Investigation No Health Public Health Monitoring
none Land Travel Illness or Death Investigation Yes Yes Fillable Fileable Form Attachment I Land Border investigation form 3_28_2012 FINAL.docx
Private Sector 259 22 0

Air Travel Illness or Death Investigation No Health Public Health Monitoring
none Air Travel Illness or Death Investigation Yes Yes Fillable Fileable Form Attachment G Air investigation Form 3_28_2012 FINAL.docx
Private Sector 1626 136 0

2013-04-05-04:00

0920-0822 201305-0920-005 0920
             
        "The National Intimate Partner and Sexual Violence Survey (NISVS)"
             
          
        
The National Intimate Partner and Sexual Violence Survey is an ongoing, nationally representative survey to assess experiences of intimate partner violence, sexual violence and stalking among adults in the US. It measures lifetime victimization for these types of violence as well as in the previous 12 months. 2014-06-30-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 54096 6078 0

National Intimate Partner and Sexual Violence Survey No Health Immunization Management
none NISVS - Spanish version Yes Yes Fillable Fileable Form Attachment K - NISVS Questionnaire - Spanish Version.docx none NISVS Yes Yes Fillable Fileable Form Attachment G- 2013 NISVS Survey_OMB - 2-27-2013.doc
Individuals or Households 9200 3833 0

National Intimate Partner and Sexual Violence Survey - Screener No Health Immunization Management
none NISVS Yes Yes Fillable Fileable Form Attachment G- 2013 NISVS Survey_OMB - 2-27-2013.doc none NISVS - Spanish version Yes Yes Fillable Fileable Form Attachment K - NISVS Questionnaire - Spanish Version.docx
Individuals or Households 44896 2245 0

2013-06-10-04:00

0920-0824 201208-0920-009 0920
             
        "BioSense"
             
          
        
BioSense is the national, human health surveillance system designed to improve the nation's capabilities for disease detection, monitoring, and real-time health situational awareness. This revision changes where data will be stored and how it will be shared. 2015-11-30-05:00 Active Carol Walker 4046394773 No No No 325 50 0

Recruitment No Health Immunization Management State, Local, and Tribal Governments 25 25 0

Access to Biosense Application No Health Immunization Management
none Application Access Yes Yes Fillable Fileable Form 0920-0824_att3_BioSense 2.0_Registration-ScreenShot.pdf
State, Local, and Tribal Governments 280 23 0

Data Collection: Administrator Sharing Permissions No Health Immunization Management
none Data Collection Sharing Yes Yes Fillable Fileable Form 0920-0824_att5_BioSense 2.0_DataSharing_ScreenShot.pdf
State, Local, and Tribal Governments 20 2 0

2012-11-05-05:00

0920-0828 201309-0920-003 0920
             
        "National Adult Tobacco Survey"
             
          
        
CDC plans to conduct three annual cycles of the National Adult Tobacco Survey (NATS) in 2012, 2013, and 2014. Questionnaire content modifications are requested for administration of the survey in 2013-2014. The NATS seeks to determine tobacco use prevalence and the factors promoting and impeding tobacco use among adults in a nationally representative sample of adults. NATS represents a partnership between CDC's Office on Smoking and Health (OSH), and the FDA's Center for Tobacco Products. 2015-07-31-04:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 241000 29850 0

National Adult Tobacco Survey Screener - Landline No Health Illness Prevention Individuals or Households 125000 4167 0

National Adult Tobacco Survey Screener - Cell Phone No Health Illness Prevention Individuals or Households 41000 683 0

National Adult Tobacco Survey - Landline No Health Illness Prevention
none Survey - Spanish Yes No Fillable Printable Form and instruction I-3. NATS 2013-2014 Questionnaire-8-29-2013-Spanish.docx none Survey - English Yes No Fillable Printable Form and instruction H-3. NATS 2013-2014 Questionnaire-8-29-2013-English.docx
Individuals or Households 56250 18750 0

National Adult Tobacco Survey - Cell Phone No Health Illness Prevention
none Survey - Spanish Yes No Fillable Printable Form and instruction I-3. NATS 2013-2014 Questionnaire-8-29-2013-Spanish.docx none Survey - English Yes No Fillable Printable Form and instruction H-3. NATS 2013-2014 Questionnaire-8-29-2013-English.docx
Individuals or Households 18750 6250 0

2013-09-30-04:00

0920-0834 201208-0920-004 0920
             
        "Occupational injuries and illnesses among emergency medical services (EMS) workers: A NEISS-Work telephone interview survey"
             
          
        
The purpose of this project is to conduct research to provide a detailed description of non-fatal occupational injuries and illnesses incurred by emergency medical services (EMS) workers. This project will use two related data sources. The first source is data abstracted from medical records of EMS workers treated in a nationally stratified sample of emergency departments (ED). These data are routinely collected by the occupational supplement to the National Electronic Injury Surveillance System (NEISS-Work). The second data source, for which the National Institute for Occupational Safety and Health (NIOSH) is seeking OMB approval, involves data collected from telephone interview surveys of injured EMS workers identified within NEISS-Work. 2014-10-31-04:00 Active Catina Conner 4046394775 No No No 150 50 0

Occupational injuries and illnesses among emergency medical services (EMS) workers: A NEISS-Work telephone interview survey No Health Health Care Services
0920-0834 EMS Worker Notification Form Yes Yes Fillable Printable Form and instruction Attachment D_100428.doc
Individuals or Households 150 50 0

2012-10-01-04:00

0920-0835 201210-0920-005 0920
             
        "Assessing the Safety Culture of Underground Coal Mining"
             
          
        
NIOSH requests OMB approval to collect safety culture data from underground coal mine employees over a three-year period to continue the assessment of the current safety culture of underground coal mining in order to identify recommendations for promoting and ensuring the existence of a positive safety culture across the industry. Up to four underground coal mines will be studied for this assessment in an attempt to study mines of different characteristics. 2015-11-30-05:00 Active Petunia Gissendaner 4046390164 No No No 1345 582 0

Assessing the Safety Culture of Underground Coal Mining Structured Interview No Workforce Management Worker Safety
None Behavior Checklists No No Paper Only Form Attachment C4 - Behavioral Checklists 7.24.12.doc None Phase D, Structured Interview Questions Database No No Paper Only Form Attachment C2 -Structured Interv Questions 7.24.12.doc None Phase D, Behavioral Anchored Rating Scales (BARS) No No Paper Only Form Attachment C3- Behavioral anchored rating scales.doc
Private Sector 201 201 0

Assessing the Safety Culture of Underground Coal Mining Survey No Workforce Management Worker Safety
No No Paper Only Other Attachment C1 - Oral Consent Script Survey 10 9 12.doc No No Paper Only Instruction Attachment D - Instructions to Respondents 7.24.12.doc None Demographic Sheet No No Paper Only Form Attachment C6- Demographic Sheet.doc None Safety Culture Survey No No Paper Only Form and instruction Attachment C5 - Safety Culture Survey 7.24.12.doc
Private Sector 1144 381 0

2012-11-26-05:00

0920-0840 201301-0920-010 0920
             
        "Formative Research and Tool Development"
             
          
        
The Centers for Disease Control and Prevention (CDC) requests approval for a revised generic information collection that supports formative research in HIV/AIDS, sexually transmitted diseases, tuberculosis, and viral hepatitis. 2016-02-29-05:00 Active Thelma Sims 4046394771 No No No 121800 46516 0

Formative Research and Tool Development: Survey of HIV Medical Care Providers to Guide the Medical Monitoring Project No Health Health Care Services
none MMP Provider Survey Web-based Application Screenshots Yes Yes Fillable Printable Form Att 2_MMPPS Screenshots.pdf none MMP Provider Survey Yes Yes Fillable Printable Form Att 3_ MMPPS Survey.docx
Private Sector 5400 1300 0

Development of a Motion Comic for HIV/STI Prevention Among Young People Ages 15-24 Phase 2 No Health Consumer Health and Safety
none Motion Comic Focus Group Guide 1 Yes No Printable Only Form Att_1b_Round 1 Focus Group Modertor Guide.docx none Motion Comic Pre Test Survey Yes Yes Fillable Fileable Form Att_1d_Participant Pre-Test Survey.docx none Motion Comic Focus Group Guide 2 Yes No Printable Only Form Att_1c_Round 2 Focus Group Modertor Guide.docx none Motion Comic Screener Yes Yes Fillable Fileable Form Att_1a_Study Screener.docx none Motion Comic Post Test Survey Yes Yes Fillable Fileable Form Att_1e_Participant Post-Test Survey.docx
Individuals or Households 540 275 0

CBO Needs Assessment for Preparedness and Resources for Support of Biomedical HIV Prevention No Health Health Care Services
None Biomedical HIV Prevention Organizational Assessment Web-based Survey Screenshots Yes Yes Fillable Fileable Form Att 9b Biomed HIV Prev Org Assessment-screenshots.docx none Consent Form Yes No Paper Only Form Att 8 Consent Form.docx Yes No Paper Only Other Att 5 Pre-test Telephone Interview Script.docx
Individuals or Households 895 323 0

Evaluation of HIV Self-Testing Among MSM in High Prevalence Cities (eSTAMP) No Health Health Care Services
none Follow-up Survey Yes Yes Fillable Fileable Form Att 1e Follow up Survey.docx Yes Yes Fillable Fileable Other Att 4d Screen shots (2) (3).docx none Registration Yes Yes Fillable Fileable Form Att 1b Study Registration.docx none Baseline Survey Yes Yes Fillable Fileable Form Att 1c Baseline Survey.docx none Reporting of Self-Test Results Yes No Fillable Fileable Form Att 1d Reporting of Self-Test results.docx none Eligibility Screener Yes Yes Fillable Fileable Form Att 1a Eligibility Screener.docx
Individuals or Households 14360 1830 0

DSTP Assessment of STD Clinic Users No Health Health Care Services
Yes Yes Printable Only Other Att 2 ConsentForm .doc none DSTDP Assessment of STD Clinic Users Yes No Paper Only Form Att 1 ClinicSurvey.doc
Individuals or Households 4400 733 0

Informing the Development of Mobile Apps for HIV Prevention, Treatment & Care No Health Consumer Health and Safety
none Usability Consent Yes No Fillable Printable Form Att_3e_Usability Consent form.docx none Consent HC Providers Yes No Fillable Printable Form Att_3d_Consent form Healthcare Providers.docx none Assent PLWH & High Risk Yes No Fillable Printable Form Att_3c_Assent form PLWH & High risk MSM.docx none Consent PLWH & High Risk Spanish Yes No Fillable Printable Form Att_3b_Consent form PLWH & High Risk MSM_SPANISH.docx none Consent PLWH & High Risk Yes No Fillable Printable Form Att_3a_Consent form PLWH & High Risk MSM.docx none End User Survey Yes No Fillable Printable Form Att_2k_End User Survey.docx none Focus Group Assessment Spanish Yes No Fillable Printable Form Att_2j_FocusGrp Assessment #2 Spanish.docx none Focus Group Assessment Yes No Fillable Printable Form Att_2i_FocusGrp Assessment 1 English.docx none HC Providers Guide Yes No Fillable Printable Form Att_2h_ModGuide HIV Healthcare Providers.docx form High Risk Guide Spanish Yes No Fillable Printable Form Att_2g_ModGuide High Risk MSM_SPANISH.docx none High Risk Guide Yes No Fillable Printable Form Att_2f_ModGuide High Risk MSM.docx none PLWH Guide Spanish Yes No Fillable Fileable Form Att_2e_ModGuide PLWH_SPANISH.docx none PLWH Guide Yes No Fillable Printable Form Att_2d_ModGuide PLWH.docx none Screener HIV Providers Yes No Fillable Printable Form Att_2c_ Screener HIV Providers.docx none Screener High Risk Yes No Fillable Fileable Form Att_2b_Screener High-Risk MSM.docx none Screener Yes No Fillable Printable Form Att_2a_Screener_PLWH.docx none Usability Assent Yes No Fillable Printable Form Att_3f_Usability Assent form.docx
Individuals or Households 692 206 0

Testing Solutions for Sampling Challenges for MMP No Health Immunization Management
none 2a - Interview questionnaire - English Yes Yes Fillable Fileable Form MMP GenIC_Testing Sampling_Att 2a_MMP Formative Research Interview_English.docx none 2b - interview questionnaire - Spanish Yes Yes Fillable Fileable Form MMP GenIC_Testing Sampling_Att 2b_MMP Formative Research Interview_Spanish.docx
Individuals or Households 2850 983 0

Testing Messages for Black and Latino MSM No Health Immunization Management
none Focus Group/Interview Guide Yes No Fillable Printable Form and instruction Attachment 2a Focus Group_Interview Guide.docx none Focus Group/Interview Guide - Spanish Version Yes No Fillable Printable Form and instruction Attachment 2b Focus Group_Interview Guide-Spanish.docx none Eligibility Screener Yes No Fillable Printable Form and instruction Attachment 1a Eligibility Screener.docx none Eligibility Screener - Spanish Version Yes No Fillable Printable Form and instruction Attachment 1b ElgibilityScreener--Spanish.docx
Individuals or Households 270 150 0

Development of CDC's Act Against AIDS Social Marketing Campaigns Targeting Consumers No Health Consumer Health and Safety Individuals or Households 5038 2061 0

Feasibility of HIV Behavioral Surveillance for Young MSM No Health Illness Prevention
0920-0840 Attachment 4_Recruitment Debriefing Yes Yes Printable Only Form and instruction Attachment 4_Recruitment Debriefing.doc 0920-0840 Attachment 6_Behavioral Assessment Yes Yes Fillable Fileable Form and instruction Attachment 6_Behavioral Assessment.docx 0920-0840 Attachment 7_Key informant interview Yes Yes Fillable Fileable Form and instruction Attachment 7_Key informant interview.docx 0920-0840 Attachment 8_Focus Group Interview Yes Yes Fillable Fileable Form and instruction Attachment 8_Focus Group Interview.docx 0920-0840 Attachment 9_Enumeration Interview Yes Yes Fillable Fileable Form and instruction Attachment 9_Enumeration Interview.docx 0920-0840 Attachment 10_Landing Page and Banner Ad Yes Yes Fillable Fileable Form and instruction Attachment 10_Landing Page and Banner Ad.docx 0920-0840 Attachment 5_Eligibility Screener Yes Yes Fillable Fileable Form and instruction Attachment 5_Eligibility Screener.docx
Individuals or Households 5446 1715 0

2013-02-01-05:00

0920-0841 201301-0920-008 0920
             
        "Management Information System for Comprehensive Cancer Control Programs"
             
          
        
CDC uses an electronic system to collect semi-annual progress reports from 65 entities that receive cooperative agreement funding for comprehensive cancer prevention and control activities (50 dates, DC, 7 territories, and 7 jurisdictions). New performance measures will be added for policy and environmental strategies. Thirteen of the awardees receive additional funding for accelerated development and implementation. Separate progress reports are required on these activities. 2016-03-31-04:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 183 586 0

Initial MIS Population for All Cancer Prevention and Control Programs No Health Immunization Management
none MIS Data Elements for All Cancer Prevention and Control Programs Yes Yes Fillable Fileable Form Appendix 4. Data for Cancer Control Programs.doc
State, Local, and Tribal Governments 22 88 0

Semi-annual Reporting for All Cancer Prevention and Control Programs No Health Immunization Management
none Data elements for CCP Programs - Semi-annual Reporting Yes Yes Fillable Fileable Form Appendix 4. Data for Cancer Control Programs.doc
State, Local, and Tribal Governments 130 390 0

Initial MIS Population for Demonstration Programs No Health Immunization Management
none Data for Demonstration Projects Yes Yes Fillable Fileable Form Appendix 5. Data for Policy Demo Programs_1-24-13.pdf
State, Local, and Tribal Governments 5 30 0

Semi-annual Reporting for Demonstration Projects No Health Immunization Management
none Data for Demonstration Projects Yes Yes Fillable Fileable Form Appendix 5. Data for Policy Demo Programs_1-24-13.pdf
State, Local, and Tribal Governments 26 78 0

2013-03-20-04:00

0920-0842 201207-0920-007 0920
             
        "STD Surveillance Network (SSuN)"
             
          
        
STD Surveillance Network is a network of 12 local and state health departments who perform active surveillance and provide detailed information on demographic characteristics, behavioral risk factors, and clinical history 1) on persons attending participating STD clinics in one of the 12 US cities and 2) on a random sample of persons diagnosed with gonorrhea within the SSuN jurisdictions. The information enables public health officials to understand characteristics of persons tested, diagnosed and treated for STDs, inform and guide STD control programs and policies, and identify and evaluate the effectiveness of public health interventions to reduce STD morbidity. 2015-09-30-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 2928 480 0

STD Clinic-based Surveillance No Health Immunization Management
none Att 3a - Clinic-based data elements Yes Yes Fillable Fileable Form and instruction Clinic_data_elements_burden.docx
State, Local, and Tribal Governments 48 96 0

Population-based Surveillance No Health Immunization Management
none Att 3b - Population-based data elements Yes Yes Fillable Fileable Form and instruction Pop_data_elements_burden.docx
Individuals or Households 2880 384 0

2012-09-07-04:00

0920-0843 201212-0920-004 0920
             
        "Field Evaluation of Prototype Kneel-Assist Devices in Low-Seam Mining"
             
          
        
The current study is aimed at evaluating the new kneel-assist devices in the mining environment. Mine workers agreeing to be a part of the study will initially be asked some basic demographic information at the commencement of the field evaluation. These questions may include age, sex, years of experience in mining, and job type. These questions will become useful when trying to group data at a later time point. Mine workers will then be given a kneepad of their choice. This type of kneepad is to be worn for the following six months. NIOSH will provide the mine workers with multiple pairs of the kneepad so that they may be replaced if they become damaged. NIOSH researchers will ask the mine workers a series of questions 1, 3, and 6 months following the commencement of the study. These questions are aimed at understanding how the mine workers perceive their kneepad of choice. Questions involve topics like body discomfort, ease of movement, usability, and durability. It is very important to understand what mine workers think of their current kneepads. In this way, we can make comparisons to the new kneel-assist devices. After six months of wearing the kneepad of their choice, the mine workers will be asked to wear the new kneel-assist devices (kneepad and body weight. 2016-01-31-05:00 Active Petunia Gissendaner 4046390164 No No No 534 216 0

Phase I Section Foreman Form No Health Illness Prevention
none Phase I Section Foreman Form No No Paper Only Form and instruction Attachment_6_-_Phase_I_Section_Foreman_Form.doc
Private Sector 3 1 0

Phase 1 Baseline Form No Health Illness Prevention
none Phase 1 Baseline Form No No Paper Only Form Attachment_7_-_Phase_I_Baseline_Form.doc
Private Sector 27 9 0

Phase 1 - 1 Month Form No Health Illness Prevention
none Phase I 1 month form No No Paper Only Form Attachment_8_-_Phase_I_1_month_form.doc
Private Sector 27 14 0

Phase 1 - Focus Group Questions Moderator Guide No Health Illness Prevention
none Phase I Focus Group Questions No No Paper Only Form and instruction Attachment_9_-_Phase_I_Focus_Group_Questions.doc
Private Sector 27 27 0

Phase 11 - Section Foreman Form No Health Illness Prevention
none Phase II Section Foreman Form No No Paper Only Form Attachment_10_-_Phase_II_Section_Foreman_Form.doc
Private Sector 72 12 0

Phase II - Baseline Form No Health Illness Prevention
none Phase II Baseline Form No No Paper Only Form Attachment_11_-_Phase_II_Baseline_Form.doc
Private Sector 54 18 0

Phase II - 1,3,6 Months Form No Health Illness Prevention
none Phase II 1,3, and 6 months Forms No No Paper Only Form and instruction Attachment_12_-_Phase_II_1_3_and_6_months_forms.doc
Private Sector 324 135 0

2013-01-04-05:00

0920-0848 201304-0920-010 0920
             
        "Laboratory Medicine Best Practices Project"
             
          
        
CDC requests OMB approval for an extension of information collection from healthcare organizations about laboratory medicine unpublished studies or in house assessments that demonstrate practice effectiveness. 2016-03-31-04:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 150 100 0

Laboratory Medicine Best Practices Project Data Submission Form No Health Health Care Services
none LMBP Project Summary Yes Yes Fillable Fileable Form and instruction Attachment C LMBP Data Submission Form and instructions.docm
Private Sector 150 100 0

2013-04-19-04:00

0920-0849 201304-0920-009 0920
             
        "School Dismissal Monitoring System"
             
          
        
The data collected by the School Dismissal Monitoring System are necessary to fulfill CDC's public health mission to prevent the spread of infectious diseases and evaluate consequences of public health emergencies in communities in the U.S. 2016-05-31-04:00 Active Petunia Gissendaner 4046390164 No No No 2500 208 0

School Dismissal Monitoring System (Reporting Form) No Health Public Health Monitoring
None School Dismissal Monitoring Sysem Yes Yes Fillable Printable Form Attachment 4 SDMS reporting form_screenshot_final.docx
State, Local, and Tribal Governments 2500 208 0

2013-05-22-04:00

0920-0850 201303-0920-002 0920
             
        "Laboratory Response Network"
             
          
        
The Laboratory Response Network is an integrated national and international network of laboratories that can respond to suspected acts of biological, chemical, or radiological terrorism and other public health emergencies. Member laboratories submit information regarding the testing capabilities of the laboratory; report all biological and chemical testing results; and participate in Proficiency Testing Challenges or Validation. 2016-04-30-04:00 Active Carol Walker 4046394773 No No No 98400 2382300 0

LRN General Surveillance Testing Results No Health Public Health Monitoring State, Local, and Tribal Governments 3750 90000 0

LRN Biennial Requalification No Health Public Health Monitoring State, Local, and Tribal Governments 150 300 0

LRN Proficiency Testing No Health Public Health Monitoring State, Local, and Tribal Governments 750 42000 0

LRN Surge Events No Health Public Health Monitoring State, Local, and Tribal Governments 93750 2250000 0

LRN Special Data Call No Health Public Health Monitoring State, Local, and Tribal Governments 0 0 0

2013-04-08-04:00

0920-0852 201310-0920-002 0920
             
        "Prevalence Survey of Healthcare Associated Infections (HAIs) and Antimicrobial Use in U.S. Acute Care Hospitals"
             
          
        
The Centers for Disease Control and Prevention (CDC) proposes to conduct two surveys to evaluate the prevalence of healthcare-associated infections (HAIs) and antimicrobial use in acute care hospitals in multiple states. Data collection was discontinued; however, this is a request for reinstatement with minor changes. 2016-12-31-05:00 Active Carol Marsh cww6@cdc.gov 404 639-4773 Yes No No 21500 6325 0

Healthcare Facility Assessment (HFA) No Health Public Health Monitoring
none Healthcare Facility Assessment Yes No Fillable Printable Form AttachmentD_FINAL_0920-0852_HFA_v8_20130725.docx
Private Sector 500 375 0

Patient Information Form (PIF) No Health Public Health Monitoring
none Patient Information Form Yes No Fillable Printable Form AttachmentE_FINAL_0920-0852_PIF_20130618.docx
Private Sector 21000 5950 0

Infection Control Practioners Prevalence Survey #2, Phase 3 No Health Public Health Monitoring
1 2010 HAI & Antimicrobial Use Point Prevalence Survey: Primary Team Data Collection Form Yes Yes Fillable Fileable Form Attachment C_PrevSurveyForms (2).docx
Private Sector 0 0 0

EIP Personnel Prevalence Survey #2, Phase #3 No Health Public Health Monitoring
1 2010 HAI & Antimicrobial Use Point Prevalence Survey: Primary Team Data Collection Form Yes Yes Fillable Fileable Form Attachment C_PrevSurveyForms (2).docx
Private Sector 0 0 0

2011 HIA and Antimicrobial Use Point Prevalence Survey - phase 3 - training and other activities No Health Public Health Monitoring
none 2011 HAI and Antimicrobial Use Point Prevalence Survey Yes Yes Fillable Fileable Form AttachmentB_0920-0852_OMBApprovedDataCollectionForm.docx
Private Sector 0 0 0

HAI and Antimicrobial Use Point Prevalence Survey - phase 3 No Health Illness Prevention
none HAI and Antimicrobial Use Point Prevalence Survey Yes Yes Fillable Fileable Form AttachmentB_0920-0852_OMBApprovedDataCollectionForm.docx
Private Sector 0 0 0

2013-12-02-05:00

0920-0853 201304-0920-019 0920
             
        "Asthma Information Reporting System (AIRS)"
             
          
        
Asthma Information Reporting System (AIRS) collects information in an electronic format from CDC's state and territorial grantees funded by the National Asthma Control Program. The data provide information about grantee activities and performance, as well as surveillance data and selected indicators on facets of asthma programs. 2016-05-31-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 72 288 0

AIRS Interim and End of Year Report No Health Illness Prevention
none AIRS Data Collection Instrument Yes Yes Fillable Fileable Form 10 Attachment 4 AIRS Data Collection Instrument (web) 20130423.pdf
State, Local, and Tribal Governments 72 288 0

2013-05-29-04:00

0920-0856 201401-0920-003 0920
             
        "National Quitline Data Warehouse"
             
          
        
The NQDW Quitline Services Survey has been redesigned to reflect the design and display of the NQDW data in State Tobacco Activities and Evaluation System. Clarified instructions are provided. 2015-10-31-04:00 Active Catina Conner 4046394775 Yes No No 564621 89035 0

Intake Information for Callers who Contact the Quitline for Someone Else No Health Illness Prevention
E1(b) NQDW Intake Questionnaire Subset Final Yes Yes Fillable Fileable Form and instruction E1(b) NQDW Intake Questionnaire_Subset Final.pdf
Individuals or Households 24688 411 0

Intake Information for Callers who Contact the Quitline for Personal Use No Health Illness Prevention
E1(a) NQDW Intake Questionnaire No No Fillable Fileable Form and instruction E1(a) NQDW Intake Questionnaire_complete final.pdf
Individuals or Households 510768 85128 0

Follow-up for Callers who Received a Quitline Service No Health Illness Prevention
F1 NQDW 7-Month Follow-Up Questionnaire No No Fillable Fileable Form and instruction F1 NQDW 7-month Follow-up Questionnaire_Final.docx
Individuals or Households 28900 3372 0

Quitline Services Questionnaire No Health Illness Prevention
G1 (2) G1 Quitline Services Online Survey file 2 Yes Yes Fillable Fileable Form and instruction G1 Quitline Services Online Survey_file 2.pdf G1 Quitline Serivces Online Survey Yes Yes Fillable Fileable Form and instruction G1 Quitline Services Online Survey_file 1.pdf none G3 Quitline Services Survey Yes Yes Fillable Fileable Form G3. NQDW Quitline Services Survey_Dec 2013.docx
State, Local, and Tribal Governments 212 71 0

Instructions for submitting caller intake and follow up No Health Illness Prevention Individuals or Households 53 53 0

2014-01-13-05:00

0920-0861 201307-0920-008 0920
             
        "A Controlled Evaluation of Expect Respect Support Groups (ERSG): Preventing and Interrupting Teen Dating Violence among At-Risk Middle and High School Students"
             
          
        
The prevalence and consequences of teen dating violence make it a public health concern that requires early and effective prevention. To date, only three prevention strategies - Safe Dates, the Youth Relationships Project, and 4th R - have demonstrated reductions in dating violence behaviors in rigorous, controlled evaluations. In order to protect young people and build an evidence-base of effective prevention strategies, evaluation of additional programs is needed, including those programs currently in the field. Expect Respect Support Groups (ERSG) were identified by CDC through the empowerment evaluation process as a program in the field that is in need of rigorous evaluation. The ERSG program has demonstrated favorable, albeit preliminary, results in a pre-post program evaluation, which strongly suggest that a controlled evaluation is needed to more rigorously examine program effects. The study has two primary goals and two exploratory aims. The primary goals are: 1) To evaluate the effectiveness of Expect Respect Support Groups (ERSG) in preventing and reducing teen dating violence and 2) To compare whether there are increased healthy conflict resolution skills reported by at-risk male and female middle and high school students participating in ERSG, compared to at-risk students in control schools who do not receive ERSG. The exploratory aims are: 1) To evaluate whether the effectiveness of ERSG is enhanced by the presence of a universal, school-wide prevention programs, and 2) To examine whether participants with different characteristics (e.g., girls vs. boys) respond differently to the intervention. 2016-08-31-04:00 Active Thelma Sims 4046394771 No No No 2248 1622 0

Intervention and Control Schools (Completion Survey) No Community and Social Services Social Services Individuals or Households 400 400 0

Intervention and Control Schools (Follow-Up Survey) No Community and Social Services Social Services Individuals or Households 400 400 0

Intake Assessment Screening Form for Expect Respect Support Groups (Intake Assessment) No Community and Social Services Social Services Individuals or Households 800 200 0

Teen Dating Violence Support Group Evaluation Survey (Baseline Survey) No Community and Social Services Social Services Individuals or Households 600 600 0

ERSG Facilitator Program Implementation Fidelity Measure No Community and Social Services Social Services Individuals or Households 16 4 0

ERSG Observational Program Implementation Fidelity Measure No Community and Social Services Social Services Individuals or Households 16 4 0

ERSG Facilitator Mid-Year Qualitative Interview No Health Immunization Management Individuals or Households 8 6 0

ERSG Facilitator End of Year Qualitative Interview No Health Immunization Management Individuals or Households 8 8 0

2013-08-21-04:00

0920-0870 201310-0920-001 0920
             
        "MONITORING AND REPORTING SYSTEM FOR CHRONIC DISEASE PREVENTION AND CONTROL PROGRAMS"
             
          
        
CDC provides funding to 50 states, the District of Columbia, Puerto Rico, and the Virgin Islands. CDC collects progress and activity information from awardees semi-annually. CDC requests approval for one year for awardees to complete their reporting requirements for the tobacco control programs. The other three programs have been discontinued (diabetes, Health Communities, and BRFSS. 2014-11-30-05:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 106 636 0

Diabetes Prevention and Control Program No Health Illness Prevention
1 Management Information System (MIS) screen shots Yes Yes Fillable Fileable Form Att 4. NCCDPHP MIS Screen Shots.docx
State, Local, and Tribal Governments 0 0 0

Tobacco Control Programs No Health Immunization Management
none CDMIS Yes Yes Fillable Fileable Form Attachment 4 OMB 0920-0870 Screenshot Final.pdf
State, Local, and Tribal Governments 106 636 0

Healthy Communities Programs No Health Illness Prevention
1 Management Information System (MIS) screen shots Yes Yes Fillable Fileable Form Att 4. NCCDPHP MIS Screen Shots.docx
State, Local, and Tribal Governments 0 0 0

Behavioral Risk Factor Surveillance Programs No Health Illness Prevention
1 Management Information System (MIS) screen shots Yes Yes Fillable Fileable Form Att 4. NCCDPHP MIS Screen Shots.docx
State, Local, and Tribal Governments 0 0 0

2013-11-21-05:00

0920-0879 201110-0920-004 0920
             
        "Surveys of State, Tribal, Local and Territorial (STLT) Governmental Health Agencies"
             
          
        
The Centers for Disease Control and Prevention (CDC) requests approval to facilitate effective and timely 2-way communications and enhance CDCs flexibility in responding to public health events. CDC's relationship with state, local, tribal and territorial (STLT) governmental health officials/employees is key to its emergency preparedness, health promotion and disease prevention responsibilities. 2014-03-31-04:00 Active Carol Walker 4046394773 No No No 120240 64440 0

CDC Guidelines for the Field Triage of Injured Patients: National Evaluation No Health Immunization Management
none Assessment of CDC Guidelines for the Field Triage of Injured Patients No No Paper Only Form FTG_ATTACH-C_Survey_Instrument_101811.docx
State, Local, and Tribal Governments 50 17 0

Evaluation of CDC Service Provided to Public Health Labs to Rapidly Identify Multidrug-Resistant Isolates of TB No Health Immunization Management
none Evaluation of Detection of Drug Resistance Testing Service Yes Yes Fillable Fileable Form ATTACHMENT C Survey Instrument-word version.docx none Drug Susceptability Test Results Yes Yes Fillable Fileable Form ATTACHMENT E. Data Collection Instrument-word version.docx
State, Local, and Tribal Governments 344 61 0

CDC Infectious Diseases Reference Laboratories Customer Satisfaction Survey No Health Immunization Management
none CDC ID Reference Labs Customer Satisfaction Survey Yes Yes Fillable Fileable Form Reference Labs - Attachment B OMB Formatted CDC Customer Survey rev.1-27-12.docx
State, Local, and Tribal Governments 55 9 0

Public Health Practice Stories from the Field No Health Immunization Management State, Local, and Tribal Governments 276 1932 0

Public Health Law Training and Technical Assistance Needs Assessment and Pandemic Influenza Nonpharmaceutical Interventions No Health Immunization Management
3 PanFlu Survey Yes Yes Fillable Fileable Form and instruction Attachment C_NonPharm PanFlu_WebSurvey.docx 4 PanFlu Web Survey Yes Yes Fillable Fileable Form and instruction Attachment D_NonPharm PanFlu_SurveyWebScreenShots.docx 2 PH Law web survey Yes Yes Fillable Fileable Form and instruction PH Law _Attach-D_ Web_Survey.docx 1 PH Law Survey Yes Yes Fillable Fileable Form and instruction PH law_Attach-C_Word Survey.docx
State, Local, and Tribal Governments 853 246 0

Evaluating the Health Hazard Evaluation Program's Communication with Local Health Departments No Health Immunization Management
none Survey (Word) Yes Yes Fillable Fileable Form HHE local health department survey Attachment G - Data collection instrument (Word).docx none Survey (Web) Yes Yes Fillable Fileable Form HHE local health department survey Attachment F - Data collection instrument (web).pdf
State, Local, and Tribal Governments 52 9 0

Technical Assistance and Service Improvement Initiative (TASII) No Health Illness Prevention
none Survey Notification Email Yes No Fillable Fileable Form Attachment K. Survey Notification Email.docx none Survey Web Screenshots Yes Yes Fillable Fileable Form Attachment H. TASII External Stakeholder Survey Instrument - Web Screen Shots.docx none Survey Reminder Emails Yes No Fillable Fileable Form Attachment L. TASII Survey Reminders (Email only).docx
State, Local, and Tribal Governments 2541 1482 0

CPPW Resource Center Feedback Assessment and IMATS Assessment No Health Immunization Management
none CPPW Web Survey Yes Yes Fillable Fileable Form Attachment D_CPPW Data Collection Instrument (Online).docx none IMATS Web Survey Yes No Fillable Fileable Form Attachment F IMATS Data Collection Instrument-Web Version.docx
State, Local, and Tribal Governments 414 138 0

Birth Certificate and Hospital Discharge Linkage - State Survey No Health Immunization Management
none Birth Certificate and Hospital Discharge - NAPHSIS Yes Yes Fillable Fileable Form Attachment B_NAPHSIS Screenshots_8 14 2012.docx none Birth Certificate and Hospital Discharge Survey - AMCHP Yes Yes Fillable Fileable Form Attachment C_AMCHP Screenshots_8 14 2012.doc
State, Local, and Tribal Governments 104 43 0

Assessment of Performance Management and Improvement Practices No Health Immunization Management
none NPHII Annual Assessment Yes Yes Fillable Fileable Form Attachment H. NPHII Annual Assessment (web version).docx
State, Local, and Tribal Governments 74 31 0

Assessment of Characteristics of State Crash Outcome Data Evaluation Systems No Health Consumer Health and Safety
0920-0879 Attachment N Email with survey link Yes Yes Fillable Printable Form and instruction Attachment N Email with survey link 10312012.docx 0920-0879 Attachment K Screen shot of questionnaire Yes Yes Fillable Printable Form and instruction Attachment K Screen shot of questionnaire.pdf 0920-0879 Attachment M Email notification 10312012 No No Printable Only Form and instruction Attachment M Email notification 10312012.docx 0920-0879 AttachmentJ - Questionnaire WORD version Yes Yes Fillable Fileable Form and instruction AttachmentJ - Questionnaire WORD version 10312012.docx Yes Yes Printable Only Instruction Attachment O survey reminder email 10312012l.docx
State, Local, and Tribal Governments 35 18 0

National Outbreak Reporting System: An Evaluation of Foodborne Disease Outbreak Surveillance and Technical Requirements for Reporting No Health Immunization Management
none Att H - Survey Screenshots Yes Yes Fillable Fileable Form and instruction NORS_evaluation_ATTACHMENT_H_SurveyInstrument_Online Version.pdf none Att G - Survey Instrument Yes Yes Fillable Fileable Form and instruction NORS_evaluation_ATTACHMENT_G_SurveyInstrument_WordVersion.docx
State, Local, and Tribal Governments 130 43 0

Assessing the Utility of the Community Guide Website and Products Among STLT Email Subscribers No Health Immunization Management
none CG Web Survey - screenshots Yes Yes Fillable Fileable Form Attach D Community Guide Web Survey of STLT Email Subscribers Web Version.pdf none CG Web Survey - Word Yes Yes Fillable Fileable Form Attach C. Community Guide Web Survey of STLT Email Subscribers Word Version.docx
State, Local, and Tribal Governments 2326 310 0

Assessing the Needs and Capacity of State Newborn Screening Programs and Laboratories No Health Immunization Management
none Newborn Screening Program Survey Yes Yes Fillable Fileable Form NBS Attachment I Newborn Screening PROGRAM data collection instrument survey monkey version.pdf none Newborn Screening Lab Survey Yes Yes Fillable Fileable Form NBS Attachment G Newborn Screening LABORATORY data collection instrument survey monkey version.pdf
State, Local, and Tribal Governments 88 45 0

State and Local Environmental Public Health Employees Usage of Public Health Assessments and Consultations Documents No Health Immunization Management State, Local, and Tribal Governments 150 125 0

Assessment of Awareness and Use of Epidemiology and Analysis Program Office Products No Health Immunization Management
none Awareness and Use of EAPO Products Yes Yes Fillable Fileable Form EAPO Assessment - Attachment H - Online Survey Screen Shots_2 13 13.docx
State, Local, and Tribal Governments 342 143 0

Assessing Analytic Tools and Practices of STLT Health Dept. Data Analysts No Health Immunization Management
none Assessment of Principal Grant Contacts Yes Yes Fillable Fileable Form SAS Attachment F_Assessment Instrument for Principal Grant Contacts for SAS Licenses (WEB).docx none Assessment of STLT Grantee SAS Users Yes Yes Fillable Fileable Form SAS Attachment H_CDC Assessment Instrument for Grantee SAS Users (WEB).docx
State, Local, and Tribal Governments 2121 955 0

Assessments of the Quality and Utility of National Public Health Improvement Initiative to Support STLT No Health Immunization Management
none Att H - TA Satisfaction Screen Shots Yes Yes Fillable Fileable Form NPHII Att H TA Tool (screenshots).docx none Focus Group Guide No No Printable Only Form and instruction NPHII Att F Focus Group Guide.docx
State, Local, and Tribal Governments 176 142 0

Assessment of Evaluation Capacity among State and Territorial Early Hearing Detection and Intervention (EHDI) Program Coodinators No Health Health Care Services
0920-0879 EHDI- Attachment D- Data Collection Instrument Word version Yes Yes Fillable Fileable Form and instruction EHDI- Attachment D- Data Collection Instrument Word version.docx Yes Yes Printable Only Instruction EHDI- Attachment E- Introductory Email.docx Yes Yes Printable Only Instruction EHDI- Attachment F- Reminder Email.docx 0920-0879 EHDI- Attachment G- Self Assessment Follow up Yes Yes Fillable Fileable Form and instruction EHDI- Attachment G- Self Assessment Follow up.docx 0920-0879 EHDI- Attachment C- Data Collection Instrument web version Yes Yes Fillable Fileable Form and instruction EHDI- Attachment C- Data Collection Instrument web version.docx
State, Local, and Tribal Governments 52 13 0

Assessment of Characteristics of State Crash Outcome Data Evaluation Systems: Focus Groups No Health Immunization Management
none Att E - Focus Group Scheduling Email Yes Yes Fillable Fileable Form and instruction Attachment E- Intro Email.docx none Att G - Screenshots of Doodle Poll Yes Yes Fillable Fileable Form Attachment G- Doodle Poll (Web).docx none Att H - Focus Group Script Yes Yes Fillable Fileable Form and instruction Attachment H- FS script.docx
State, Local, and Tribal Governments 116 189 0

Assessment of Public Health Veterinarians Regarding the Sale, Display, and Exhibition of "Exotic" Animals No Health Immunization Management
none Assessment of Public Health Veterinarians Regarding the Sale, Display, and Exhibition of "Exotic" Animals Yes Yes Fillable Fileable Form and instruction Attachment B- Instrument_word version.docx Yes Yes Printable Only Other Attachment C- Instrument_Screenshot.pdf
State, Local, and Tribal Governments 66 19 0

Assessment of State/Local STD Clinic Directors Perceptions and Attitudes Regarding CDC Field Staff No Health Immunization Management
0920-0879 STD Field Staff ATTACHMENT C Instrument-Online Yes Yes Fillable Fileable Form and instruction STD Field Staff ATTACHMENT C Instrument-Online.docx 0920-0879 STD Field Staff ATTACHMENT B Instrument Yes Yes Fillable Fileable Form and instruction STD Field Staff ATTACHMENT B Instrument-MS Word.docx
State, Local, and Tribal Governments 59 30 0

Assessment of Local Health Departments' Interventions to Address TB among Persons Experiencing Homelessness No Health Immunization Management
None Health Department Homeless TB Data Collection Instrument Yes Yes Fillable Fileable Form ATTACHMENT B TB Homeless Instrument- Word v81313.docx None Health Department Homeless TB Data Collection Instrument--Screenshots Yes Yes Fillable Fileable Form ATTACHMENT C TB Homeless Instrument-Web.docx
State, Local, and Tribal Governments 220 73 0

Assessing Effectiveness Brochure: LHD/NHHE Progam Working Together AND STD Prevention Services No Health Health Care Services State, Local, and Tribal Governments 877 209 0

Assessing Satisfaction and Utility of OSTLTS Communication Products for Health Department Staff No Health Immunization Management
None Attachment G--Assessing Satisfaction and Utility of OSTLTS Communication Products for Health Department Staff--Web-version Yes Yes Fillable Fileable Form and instruction Attachment G- Instrument (Web Version).docx None Attachment F: Assessing Satisfaction and Utility of OSTLTS Communication Products for Health Department Staff-Word Version Yes Yes Fillable Fileable Form and instruction Attachment F - Instrument (Word Version).docx
State, Local, and Tribal Governments 750 188 0

Assess Breast and Cervical Cancer Screening Program Activities to Expand Access to Screening No Health Public Health Monitoring
none Assess Breast and Cervical Cancer Screening Program Activities Yes Yes Fillable Fileable Form Attachment C - Data Collection Instrument -Web Version.doc
State, Local, and Tribal Governments 67 31 0

Assessment of State Public Health Department Immunization Billing Reimbursement Projects No Health Immunization Management
none Billables Project Assessment Yes Yes Fillable Fileable Form Attachment G-Data Collection Instrument Web Version.docx
State, Local, and Tribal Governments 35 20 0

Case Study of the Career Epidemiology Field Officer Assignments in Three State Health Department No Health Consumer Health and Safety
none Partner Interview No No Printable Only Form and instruction CEFO ATTACHMENT C- Partner Instrument_11 21 13.docx none Supervisor Interview No No Printable Only Form and instruction CEFO ATTACHMENT B- Supervisor Instrument_11 21 13.docx
State, Local, and Tribal Governments 18 15 0

Health Department Use and Application of CDC Drug Resistant TB Laboratory Services No Health Immunization Management State, Local, and Tribal Governments 60 15 0

Utility and Value of Flexible Epidemiologists No Health Immunization Management
none Interview Guide - PI No No Printable Only Form Attachment B Interview Guide - Version PI_ 12 2 13.docx none Interview Guide - Epidemiologist No No Printable Only Form Attachment C Interview Guide - Version FE_12 2 13.docx
State, Local, and Tribal Governments 20 13 0

Biosense Submission Processes Assessment No Health Immunization Management State, Local, and Tribal Governments 56 85 0

SHD Reporting (14EU) and Testing Practices and TB Elimination FOA (14GS) No Health Illness Prevention
none Survey for Epidemiologist Yes Yes Fillable Fileable Form Attachment F Campy Data Collection Epi Instrument (online version) 12 13 13.docx none Survey for Microbiolgist Yes Yes Fillable Fileable Form Attachment K Campy Data Collection Lab Instrument (online version) 12 13 13.docx none TB Instrument - Web Yes Yes Fillable Fileable Form ATTACHMENT B- Data Collection Instrument_Online Version docx.docx
State, Local, and Tribal Governments 230 58 0

2011-10-14-04:00

0920-0881 201101-0920-004 0920
             
        "Data Calls for the Laboratory Response Network"
             
          
        
CDC is requesting OMB approval of an Existing collection in use without an OMB Control Number (Generic clearance). Although the Laboratory Response Network (LRN) Program Office at CDC has an extensive database of information regarding all network members, Special Data Calls are sometimes needed to address issues concerning the response capabilities of member facilities for priority threat agents or to assess the network's ability to respond to new emerging threats. Special Data Calls may be conducted via broadcast e-mail that asks respondent to send information via email to the LRN help desk or through online survey tools (i.e., Survey Monkey) which require respondents to go to a web link and answer a series of questions. 2014-03-31-04:00 Active Thelma Sims 4046394771 No No No 800 400 0

CDC Data Calls for Laboratory Response Network No Health Public Health Monitoring State, Local, and Tribal Governments 800 400 0

2011-03-21-04:00

0920-0886 201102-0920-001 0920
             
        "The Evaluation of Ordinances to Prevent Workplace Violence in Convenience Stores"
             
          
        
In 1997-2008, there were 1,800 homicides of retail workers of which 1,572 were due to robbery or assaults. Situational Crime Prevention programs to reduce robbery and violent crime have been proven to be successful in reducing robbery and robbery-related injury risk to both employees and customers in retail settings. These programs incorporate a criminological concept called Crime Prevention Through Environmental Design (CPTED) which theorizes that environments can be modified to make potential criminals feel they are being watched, i.e. under surveillance and thus vulnerable, resulting in avoidance of the target by increasing the robber's perception that a robbery is not worth the risk. NIOSH is conducting an evaluation of the effectiveness of convenience store safety ordinances in Dallas and Houston, Texas. The goals of this research are to 1) determine if the ordinances effectively increase the frequency of implementation of CPTED components in stores and decrease robbery and assaults to workers and customers; 2) determine the benefits to stores from compliance to the city ordinance; 3) determine the process the cities used for ordinance development and their recommendations to other cities, and 4) develop evidence-based recommendations to promote CPTED programs and to aid other cities which are considering safety ordinances for their retail industry. 2014-05-31-04:00 Active Carol Walker 4046394773 No No No 815 495 0

Store Managers No Health Public Health Monitoring Private Sector 600 300 0

Store Owner/ Upper Management No Health Public Health Monitoring Private Sector 35 105 0

Stakeholders (Industry leaders/Community leaders) No Health Public Health Monitoring Private Sector 180 90 0

2011-05-02-04:00

0920-0888 201102-0920-002 0920
             
        "Persistence of Viable Influenza Virus in Aerosols"
             
          
        
The purpose of this study is to measure the amount of viable influenza virus in airborne particles that are produced by patients when they cough, and the size and quantity of the particles carrying the virus. 2014-05-31-04:00 Active Thelma Sims 4046394771 No No No 372 84 0

Initial Participants (Health Questionnaire) Phase 1 No Health Illness Prevention Individuals or Households 44 4 0

Qualified Participants (Testing) Phase 1 No Health Illness Prevention Individuals or Households 40 17 0

Qualified Participants (Informed Consent) Phase 1 No Health Illness Prevention Individuals or Households 40 7 0

Qualified Participants (Informed Consent) Phase 2 No Health Illness Prevention Individuals or Households 40 7 0

Qualified Participants (Informed Consent) Phase 3 No Health Illness Prevention Individuals or Households 40 7 0

Qualified Participants (Testing) Phase 2 No Health Illness Prevention Individuals or Households 40 17 0

Qualified Participants (Testing) Phase 3 No Health Illness Prevention Individuals or Households 40 17 0

Initial Participants (Health Questionnaire) Phase 2 No Health Illness Prevention Individuals or Households 44 4 0

Initial Participants (Health Questionnaire) Phase 3 No Health Illness Prevention Individuals or Households 44 4 0

2011-05-20-04:00

0920-0889 201210-0920-012 0920
             
        "Using Traditional Foods and Sustainable Ecological Approaches for Health Promotion and Diabetes Prevention in American Indian/Alaska Native Communities"
             
          
        
CDC requests minor changes in the information collection instrument to clarify wording and to improve usability and respondent satisfaction. 2014-06-30-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 40 80 0

Traditional Foods Shared Data Elements No Health Consumer Health and Safety
none Traditional Foods SDE Reporting Yes Yes Fillable Fileable Form Att 4a (rev) Traditional Foods SDE Oct 2012.pdf
State, Local, and Tribal Governments 34 68 0

Retrospective Data Collection No Health Consumer Health and Safety
none Shared data elements - screen shots Yes Yes Fillable Fileable Form Att 4a. Traditional Foods SDEs 03222011.pdf
State, Local, and Tribal Governments 6 12 0

2012-10-31-04:00

0920-0890 201104-0920-014 0920
             
        "HIV/AIDS Awareness Day Programs"
             
          
        
The proposed data collection contains key features that address funded capacity building activities. Collecting program information through a web-based system about four of the HIV/AIDS Awareness Day programs are important to determine success and improve the CDC's overall capacity building assistance (CBA) programs. 2014-06-30-04:00 Active Petunia Gissendaner 4046390164 No No No 375 375 0

National Asian & Pacific Islander HIV/AIDS Awareness Day Evaluation Report No Health Immunization Management
5 National Asian & Pacific Islander HIV/AIDS Awareness Day Evaluation Report Yes Yes Fillable Fileable Form Att 5 API HIVAIDS Evaluation Report.docx
Individuals or Households 15 15 0

Title National Latino AIDS Awareness Day Evaluation Report No Health Immunization Management
7 NLAAD_Survey-Revised 6-2-2011 Yes Yes Fillable Fileable Form NLAAD_Survey-Revised 6-2-2011.docx
Individuals or Households 125 125 0

National Black HIV/AIDS Awareness Day Evaluation Report No Health Immunization Management
3 National Black HIV/AIDS Awareness Day Evaluation Report Yes Yes Fillable Fileable Form and instruction Att 3 NBHAAD 2011 Online Evaluation (2) (3) docx3-16-11.docx
Individuals or Households 200 200 0

National Native HIV/AIDS Awareness Day Evaluation Report No Health Immunization Management
4 Native American HIV/AIDS Awareness Day Evaluation Report Yes Yes Fillable Fileable Form Att 4 NNHAAD_survey2010 (2) (6) docx3-16-11.docx
Individuals or Households 35 35 0

2011-06-27-04:00

0920-0891 201307-0920-001 0920
             
        "World Trade Center Health Program Enrollment, Appeals & Reimbursement"
             
          
        
This is a request to extend data collection beyond the current expiration date. The collection will continue to collect enrollment and appeals data as required by the James Zadroga 9/11 Health and Compensation Act of 2010 (Zadroga Act). The Zadroga Act which was passed on December 22, 2010 establishes a federal program to support health monitoring and treatment for emergency responders; recovery and cleanup workers; and residents, building occupants, and area workers in New York City who were directly impacted and adversely affected by the terrorist attacks of September 11, 2001. All responders to the New York City attack who will be newly seeking medical monitoring and treatment and survivors of the attack who were not covered by the Medical Monitoring and Treatment Program (MMTP) prior to January 2, 2011, may apply to obtain coverage under the new WTC Health Program. In order to begin the determination eligibility process, an enrollment form must be completed. There are three separate enrollment forms for each population of responders (FDNY responders, non-FDNY responders, and Survivors). The enrollment form will collect general contact information as well as information regarding the WTC disaster area experience. In order to reduce the burden on the respondents and survivors, the WTC Health program will make the form available to be downloaded from the internet or obtained in hard copy and submitted by mail. 2014-12-31-05:00 Active Petunia Gissendaner 4046390164 No No No 77243 19161 0

88.5 World Trade Center Health Program FDNY Responder Eligibility App No Health Health Care Services Individuals or Households 189 95 0

88.5 World Trade Center Health Program Responder App (Other than FDNY) No Health Health Care Services
88.5 World Trade Center Health Program Responder App (Other than FDNY) No No Printable Only Form and instruction Appendix D Revised Eligibility Form for Responders Non FDNY 20110623.doc
Individuals or Households 2979 1490 0

88.9 World Trade Center Health Program Survivor Eligibility Application No Health Health Care Services Individuals or Households 1560 390 0

88.11 Denial Letter and Appeal Notification Eligibility No Health Health Care Services Individuals or Households 47 24 0

88.12 World Trade Center Health Condition Certification Request No Health Health Care Services
2 New Determinations for WTC Certification Yes No Fillable Printable Form and instruction Attachment J.docx
Individuals or Households 32200 16100 0

88.15 Denial Letter and Appeal Notification Treatment No Health Health Care Services Individuals or Households 588 294 0

88.15 Denial Letter and Appeal Notification- Health Conditions No Health Health Care Services Individuals or Households 30 15 0

Outpatient Prescription Pharmaceuticals No Health Health Care Services Individuals or Households 39150 653 0

88.16 Travel Expenses No Health Health Care Services Individuals or Households 10 2 0

Currently Identified Responders and Currently Identified Survivors No Health Health Care Services
12 Eligibility and Qualification for WTC Health Program Yes No Paper Only Form Appendis B Eligibility and Qualification 20110623.doc
Individuals or Households 290 48 0

ACH Vendor/Miscellaneous Payment Enrollment Form No Health Health Care Services
11 ACH Vendor/Miscellaneous Payment Enrollment Form Yes No Paper Only Form and instruction Attachment M SF 3881 ACH Vendor_Misc Payment Enrollment Form.pdf
Private Sector 200 50 0

2013-07-03-04:00

0920-0892 201401-0920-002 0920
             
        "Clostridium difficile Infection (CDI) Surveillance"
             
          
        
Steady increases in the rate and severity of Clostridium difficile infection (CDI) indicate a clear need to conduct longitudinal assessment of the impact of CDI in the United States. C. difficile is an anaerobic, spore-forming, gram positive bacillus that produces two pathogenic toxins. A and B. CDI ranges in severity from mild diarrhea to fulminant colitis and death. 2017-02-28-05:00 Active Carol Marsh cww6@cdc.gov 404 639-4773 No No No 1100 383 0

Screening Form No Health Illness Prevention
New form Attachment E Screening Questions for CDI No No Fillable Printable Form and instruction Attachment E - Screening Questions for Clostridium difficile Telephone Interview.doc
Individuals or Households 600 50 0

Telephone Interview No Health Illness Prevention
New form Attachment F CDI Health Interview Yes Yes Fillable Printable Form and instruction Attachment F _ CDI Health Interview Attachment.doc
Individuals or Households 500 333 0

2014-02-03-05:00

0920-0895 201108-0920-003 0920
             
        "Community-based Organization (CBO) Monitoring and Evaluation Project of RESPECT (CMEP-RESPECT)"
             
          
        
The Community-based Organization (CBO) Monitoring and Evaluation Project (CMEP) of Respect has two purposes: 1) to monitor changes in client's self-reported HIV risk behaviors and attitudes after participating in the Effective Behavioral Intervention (EBI) Respect as delivered by CDC-funded CBOs and 2) to assess the fidelity of the delivery of Respect at CBOs. From July 2010 through July 2015, CMEP will provide additional funds through FOA 10-1003 to four CBOs to collect outcome monitoring data from 400 men who have sex with men (MSM) who are participating in Respect as well as process and fidelity assessment data about the implementation of the interventions. CMEP-Respect will employ a repeated measures design to collect client-level data before the intervention and then again at three-months and six-months following the intervention. Findings will help to further understanding of how these interventions are delivered once they leave the research arena and whether or not they are associated with behavior change. Ultimately this information will help CBOs improve their intervention delivery and better serve clients. 2014-08-31-04:00 Active Petunia Gissendaner 4046390164 No No No 1732 358 0

Eligibility--Screener No Health Immunization Management
1 Eligibility Screener Yes Yes Fillable Printable Form and instruction Att 3_Eligibility Screener.pdf
Individuals or Households 500 17 0

Eligibility--Screener--Grantee No Health Immunization Management Individuals or Households 48 4 0

Baseline Interview No Health Immunization Management
3 Baseline Interview Yes Yes Fillable Fileable Form and instruction Att 5a_Baseline Survey.pdf
Individuals or Households 400 133 0

Baseline Interview--Grantee No Health Immunization Management Individuals or Households 48 4 0

90-day follow-up Interview No Health Immunization Management
4 90-day Follow-up Interview Yes Yes Fillable Fileable Form and instruction Att 5b_90-Day Follow-up Survey.pdf
Individuals or Households 320 96 0

90-day follow-up Interview--Grantee No Health Immunization Management Individuals or Households 48 4 0

180-day Follow-up Interview No Health Immunization Management
4 180-day Follow-up Interview Yes Yes Fillable Fileable Form and instruction Att 5c_180-Day Follow-up Survey.pdf
Individuals or Households 320 96 0

180-day Follow-up Interview--Grantee No Health Immunization Management Individuals or Households 48 4 0

2011-08-12-04:00

0920-0896 201108-0920-002 0920
             
        "Community-based Organization (CBO) Monitoring and Evaluation Project (CMEP) of WILLOW (CMEP-WILLOW)"
             
          
        
The Community-based Organization (CBO) Monitoring and Evaluation Project (CMEP) of WILLOW has two purposes: 1) to monitor changes in client's self-reported HIV risk behaviors and attitudes after participating in the Effective Behavioral Intervention (EBI) WILLOW as delivered by CDC-funded CBOs and 2) to assess the fidelity of the delivery of WILLOW at CBOs. From July 2010 through July 2015, CMEP will provide additional funds through FOA 10-1003 to four CBOs to collect outcome monitoring data from 400 women who are living with HIV and participating in WILLOW as well as process and fidelity assessment data about the implementation of the interventions. CMEP-WILLOW will employ a repeated measures design to collect client-level data before the intervention and then again at three-months and six-months following the intervention. Findings will help to further understanding of how these interventions are delivered once they leave the research arena and whether or not they are associated with behavior change. Ultimately this information will help CBOs improve their intervention delivery and better serve clients. 2014-08-31-04:00 Active Petunia Gissendaner 4046390164 No No No 1732 358 0

Eligibility Screener No Health Immunization Management
1 Eligibility Screener No No Paper Only Form and instruction 0920-New_att3_Eligibility Screener.pdf
Individuals or Households 500 17 0

Eligibility Screener--Grantees No Health Immunization Management Individuals or Households 48 4 0

Baseline Survey No Health Immunization Management
3 Baseline Survey No No Paper Only Form and instruction 0920-New_att5a_Baseline Survey.pdf
Individuals or Households 400 133 0

Baseline Survey--Grantees No Health Immunization Management Individuals or Households 48 4 0

90-day Follow-up Interview No Health Immunization Management
6 90-day Follow-up Interview Yes Yes Fillable Fileable Form and instruction 0920-New_att5b_90-Day Follow-up_Survey.pdf
Individuals or Households 320 96 0

90-day Follow-up Interview--Grantees No Health Immunization Management Individuals or Households 48 4 0

180-day Follow-up No Health Immunization Management
7 180-day Follow-up Interview Yes Yes Fillable Fileable Form and instruction 0920-New_att5c_180-Day Follow-up_Survey.pdf
Individuals or Households 320 96 0

180-day Follow-up Interview--Grantee No Health Immunization Management Individuals or Households 48 4 0

2011-08-12-04:00

0920-0900 201106-0920-017 0920
             
        "Contact investigation Outcome Reporting Forms"
             
          
        
CDC's Division of Global Migration and Quarantine has developed contact investigation outcome reporting forms for the different types of investigations. This new data collection called "Contact Investigation Outcome Reporting Form supports the need for CDC Quarantine staff to evaluate its contact investigation investigative protocols and in determining if adequate information on each contact was provided to those responsible for contacting passengers believed to have been exposed to a communicable disease during travel. 2014-09-30-04:00 Active Thelma Sims 4046394771 No No No 3347 280 0

Optional TB Air/Land Contact Investigaiton Outcome Reporting Form No Health Public Health Monitoring State, Local, and Tribal Governments 2154 180 0

Optional TB Maritime Contact Investigation Outcome Reporting Form No Health Public Health Monitoring State, Local, and Tribal Governments 190 16 0

Optional Measles, Mumps or Rubella Air/Land Contact Investigation Outcome Reporting Form No Health Public Health Monitoring State, Local, and Tribal Governments 367 31 0

Optional Measles, Mumps, or Rubella Maritime Contact Investigation Outcome Reporting Form No Health Public Health Monitoring State, Local, and Tribal Governments 140 12 0

Optional General Air/Land Contact Investigation Outcome Reporting Form No Health Public Health Monitoring State, Local, and Tribal Governments 456 38 0

Optional General Maritime Contact Investigation Outcome Reporting Form No Health Public Health Monitoring State, Local, and Tribal Governments 40 3 0

2011-09-05-04:00

0920-0902 201107-0920-001 0920
             
        "Fetal-Infant Mortality Review: Human Immunodeficiency Virus Prevention Methodology (FHPM)"
             
          
        
The Fetal-Infant Mortality Review-Human Immunodeficiency Virus Prevention Methodology (FHPM) project is based upon the Fetal & Infant Mortality Review (FIMR). FIMR is an action-oriented community process that continually assesses, monitors, and works to improve service systems and community resources for women, infants, and families. The goal of the FIMR/HIV Prevention Methodology is to improve perinatal HIV prevention systems by using the FIMR case review and community action process. The original FIMR methodology was an approach designed to lead to community-level improvements in infant health outcomes. FHPM has adapted these steps in order to evaluate and address the causes of perinatal HIV transmission in communities. Both the FHPM and FIMR methodologies consist of four steps: Data gathering, case review, community action, and changes in community systems. The recommendations and findings of the CRT are then passed on to a Community Action Team (CAT), which is a diverse, broad-based group of community leaders and representatives capable of defining and initiating changes in the local systems. FHPM is designed to identify and address missed prevention opportunities at the community level. 2014-09-30-04:00 Active Petunia Gissendaner 4046390164 No No No 300 450 0

FIMR/HIV Maternal Interview Form No Health Illness Prevention
2 Maternal Interview Consent Form Yes No Fillable Fileable Form and instruction Maternal Interview Consent Form.docx 1 Maternal Interview Form Yes No Fillable Fileable Form and instruction Maternal Interview Form.docx
Individuals or Households 300 450 0

2011-09-29-04:00

0920-0903 201107-0920-009 0920
             
        "Exploring the OSH Needs of Small Construction Business"
             
          
        
Exploring the OSH Needs of Small Construction Business is a four year field study whose overall goal is to identify the occupational safety and health (OSH) needs of small construction businesses (SCBs), and to inform methods that will successfully motivate SCB owners to seek OSH training relevant to their unique work situations. In addition, the Exploring the OSH Needs of Small Construction Business field study will lay the foundation for critical work to follow, aimed at disseminating OSH intervention materials to SCB owners which will enable and motivate them to enhance their OSH management efforts. The data gathered in this study regarding SCB owners businesses' specific training needs, motivational factors, and preferred information sources will be of significant practical value when designing and implementing future interventions. 2014-10-31-04:00 Active Daniel Holcomb dwh6@cdc.gov 770 488-4472 No No No 30 45 0

Interview of SCB Owners No Health Immunization Management Private Sector 30 45 0

2011-10-17-04:00

0920-0904 201109-0920-007 0920
             
        "SEARCH for Diabetes in Youth Study"
             
          
        
CDC requests OMB approval to collect de-identified, case-level information from five SEARCH sites that are participating in Phase 3 of a longitudinal study of diabetes in youth, and a case registry. 2014-11-30-05:00 Active Thelma Sims 4046394771 No No No 15750 6135 0

SEARCH - Initial Participant Survey - Parent/Gardian (Inpatient) No Health Public Health Monitoring Private Sector 1275 213 0

SEARCH Medical Inventory No Health Public Health Monitoring Private Sector 1275 106 0

SEARCH Inpatient Survey (Initial Participant Survey - Parent/Guardian) No Health Public Health Monitoring Private Sector 0 0 0

SEARCH Specimen Collection Form No Health Public Health Monitoring Private Sector 1275 425 0

SEARCH Physical Examination Form No Health Public Health Monitoring Private Sector 1275 1700 0

SEARCH Health Questionnaire - Youth/ & Parent Versions No Health Public Health Monitoring Private Sector 1420 355 0

SEARCH Health Questionnaire - Parent Version No Health Public Health Monitoring Private Sector 0 0 0

SEARCH CES-Depression No Health Public Health Monitoring Private Sector 710 47 0

SEARCH Medical Record Validation of Self-Report No Health Public Health Monitoring Private Sector 0 0 0

SEARCH Quality of Care Survey No Health Public Health Monitoring Private Sector 710 154 0

SEARCH PedsQL No Health Public Health Monitoring Private Sector 710 59 0

SEARCH MNSI No Health Public Health Monitoring Private Sector 710 118 0

SEARCH Diabetes Eating Problem Survey (DEPS-R) No Health Public Health Monitoring Private Sector 710 59 0

SEARCH Low Blood Surgar Survey No Health Public Health Monitoring Private Sector 710 59 0

SEARCH Supplemental Questionnaire No Health Public Health Monitoring Private Sector 710 118 0

SEARCH Tanner Stage No Health Public Health Monitoring Private Sector 710 59 0

SEARCH Pathology Notificaiton (Retinal Photo) No Health Public Health Monitoring Private Sector 710 178 0

SEARCH Diabetes Related Family Conflict Survey No Health Public Health Monitoring Private Sector 710 59 0

Peds QL Diabetes Module No Health Public Health Monitoring Private Sector 710 59 0

SEARCH Physical Examination Form No Health Public Health Monitoring Private Sector 710 2130 0

SEARCH Specimen Collection Form No Health Public Health Monitoring Private Sector 710 237 0

SEARCH Unanticipated Occurrence/Condition Reporting Form No Health Public Health Monitoring Private Sector 0 0 0

2011-11-06-05:00

0920-0905 201105-0920-003 0920
             
        "FoodNet Non-0157 Shiga Toxin-Producing E.coli Study: Assessment of Risk Factors for Laboratory-Confirmed Infections and Characterization of Illnesses by Microbiological Characteristics"
             
          
        
Each year many Shiga toxin-producing E. coli (STEC) infections occur in the USm ranging from mild diarrhea to life-threatening hemolytic uremic syndrome (HUS). HUS occurs most frequently following infection with serogroup 0157 and has a fatality rate of 5%. Although studied less than 0157 STEC, non-0157 STEC are of public health importance. The FoodNet case-control study will be the first multistate study of non-outbreak-associated non-0157 STEC infections in the US. It will investigate risk factors as a group and individually for the most common non-0157 STEC serogroups. It will characterize the major known virulence factors to assess how risk factors and clinical features vary by virulence factor profiles. It would contribute to better understanding of non-0157 STEC infections and to provide science-based recommendations for preventive interventions. 2014-11-30-05:00 Active Carol Walker 4046394773 No No No 644 268 0

Case Questionnaire No Health Immunization Management
Case Questionnaire case Questionnaire No Paper Only Form Case Questionnaire_10-31-11.doc
Individuals or Households 161 67 0

Control Questionnaire No Health Immunization Management
Control Questionnaire Control Questionnaire No Paper Only Form Control Questionnaire_10-31-11.doc
Individuals or Households 483 201 0

2011-11-06-05:00

0920-0906 201112-0920-013 0920
             
        "The Green Housing Study"
             
          
        
This is a request to add Spanish and Chinese translations of the questionnaires and documents. 2014-11-30-05:00 Active Daniel Holcomb dwh6@cdc.gov 770 488-4472 No No No 25960 2356 0

Screening Questionnaire No Health Immunization Management
none Screening Questionnaire Yes No Paper Only Form Appendix D12 - Screening questionnaire 7-5-11.doc
Individuals or Households 1000 167 0

Baseline Questionnaire - Home Characteristics No Health Immunization Management
N/A REVISED_APPENDIX_D1_Baseline (Home Characteristics)_October 20.2011 Yes No Paper Only Form REVISED_APPENDIX_D1_Baseline (Home Characteristics)_October 20.2011.doc
Individuals or Households 832 208 0

Baseline Questionnaire Part 2 - Home Characteristics No Health Immunization Management
N/A REVISED_APPENDIX_D2_Baseline (Part 2 Home Characteristics)_October 20.11 Yes No Paper Only Form REVISED_APPENDIX_D2_Baseline (Part 2 Home Characteristics)_October 20.11.doc
Individuals or Households 832 69 0

Baseline Questionnaire - Demographics No Health Immunization Management
none Baseline Questionnaire (Demographics) Yes No Paper Only Form Appendix D3 - Baseline ( Demographics) 6-29-11.doc
Individuals or Households 832 69 0

Baseline Questionnaire for Children No Health Immunization Management
none Baseline Questionnaire Children Yes No Paper Only Form Appendix D4 - Baseline (for Children 7-12 years) 5-10-11.doc
Individuals or Households 832 208 0

Monthly Text Messages No Health Immunization Management Individuals or Households 6656 111 0

Three and Nine Month Phone Contact No Health Immunization Management
none 3 and 9 Month Follow-up Yes No Paper Only Form Appendix D5 -3 and 9-m (Children with asthma 7-12 years) 5-10-11.doc
Individuals or Households 1664 139 0

Six and Twelve Month Follow-up Questionnaire - for Environment No Health Immunization Management
none 6 and 12 month Follow-up - Environment Yes No Paper Only Form Appendix D7 -6 & 12-mo Follow-up (Environment) 7-1-2011.doc
Individuals or Households 1664 277 0

Six and Twelve Month Follow-up Questionnaire - for Children No Health Immunization Management
none 6 and 12 month Follow-up Children Yes No Paper Only Form Appendix D8 -6 and 12-mo (Children 7-12 years) 7-1-11.doc
Individuals or Households 1664 277 0

Time / Activity Form - for Children No Health Immunization Management
none Time / Activity - Children Yes No Paper Only Form Appendix D10 - Time Activity (Children 7-12 yrs) 5-5-11.doc
Individuals or Households 3328 277 0

Illness Checklist No Health Immunization Management
none Illness Checklist Yes No Paper Only Form Appendix D9 - Illness Checklist (Children 7-12 years) 5-10-11.doc
Individuals or Households 3328 277 0

Time / Activity Form - for Mothers / Primary Caregivers No Health Immunization Management
N/A REVISED_APPENDIX_D11_Time Activity (Mother- Primary Caregiver)_October 20.2011 No No Paper Only Form REVISED_APPENDIX_D11_Time Activity (Mother- Primary Caregiver)_October 20.2011.doc none Time / Activity - Caregiver No No Paper Only Form Appendix D11 -Time Activity (Mother- Primary Caregiver) 5-5-11.doc
Individuals or Households 3328 277 0

2011-12-20-05:00

0920-0907 201108-0920-004 0920
             
        "Musculoskeletal Disorder (MSD) Intervention Effectiveness in Wholesale/ Retail Trade Operations"
             
          
        
NIOSH proposes to conduct a study to assess the effectiveness and cost-benefit of occupational safety and health (OSH) interventions for musculoskeletal disorders (MSDs) among wholesale/ retail trade (WRT) workers. For the current study, NIOSH and the Ohio Bureau of Workers Compensation (OBWC) will collaborate on a multi-site intervention study at OBWC-insured WRT companies from 2011-2014. In overview, MSD engineering control interventions [stair-climbing, powered hand trucks (PHT) and powered truck lift gates(TLG)] will be tested for effectiveness in reducing self-reported back and upper extremity pain among 960 employees performing delivery operations in 72 WRT establishments using a prospective experimental design (multiple baselines across groups with randomization). Twenty-four OBWC-insured WRT establishments will be recruited from each of three total employee categories (<20 employees, 20-99 employees, and 100+ employees) for a total of 72 establishments with 3,240 employees. This study will determine the effectiveness of the tested MSD interventions for WRT delivery workers and enable evidence based prevention practices to be shared with the greatest audience possible. NIOSH expects to complete data collection in 2014. 2014-11-30-05:00 Active Petunia Gissendaner 4046390164 No No No 15701 1500 0

Informed Consent (Questionnaire Data Collection) No Workforce Management Worker Safety
1 Informed Consent (Questionnaire Data Collection) Yes Yes Fillable Fileable Form and instruction Attachment G-1.docx
Private Sector 480 40 0

Informed Consent- Low Back Functional Assessment No Workforce Management Worker Safety
2 Informed Consent- Low Back Functional Assessment Yes Yes Fillable Fileable Form and instruction Attachment G-2.docx
Private Sector 480 40 0

Self-reported low back pain questionnaire No Workforce Management Worker Safety
3 Self-reported low back pain questionnaire Yes Yes Fillable Fileable Form and instruction Attachment H-1 .docx
Private Sector 4320 360 0

Self-Reported Upper Extremity Pain Questionnaire No Workforce Management Worker Safety
4 Self-Reported Upper Extremity Pain Questionnaire Yes Yes Fillable Fileable Form and instruction Attachment H-2 .docx
Private Sector 4320 360 0

Self-Reported Specific Job Tasks and Safety Incidents Questionnaire No Workforce Management Worker Safety
5 Self-Reported Specific Job Tasks and Safety Incidents Questionnaire Yes Yes Fillable Fileable Form and instruction Attachment H-3 .docx
Private Sector 4320 360 0

Self-Reported General Work Environment and Health Questionnaire No Workforce Management Worker Safety
6 Self-Reported General Work Environment and Health Questionnaire Yes Yes Fillable Fileable Form and instruction Attachment H-4 .docx
Private Sector 1440 240 0

Low Back Functional Assessment No Workforce Management Worker Safety
7 Low Back Functional Assessment Yes Yes Fillable Fileable Form and instruction Attachment I .docx
Private Sector 288 96 0

Early Exit Interview No Workforce Management Worker Safety
8 Early Exit Interview No No Paper Only Form and instruction Attachment H-5 .docx
Private Sector 53 4 0

2011-11-17-05:00

0920-0909 201203-0920-003 0920
             
        "CDC Diabetes Prevention Recognition Program"
             
          
        
The Patient Protection and Affordable Care Act directed CDC to establish a national diabetes prevention program. Community-based organizations may apply to CDC for recognition of their programs. Information will be collected to monitor, evaluate and provide technical assistance to these organizations. 2014-11-30-05:00 Active Petunia Gissendaner 4046390164 No Yes No 600 600 0

Application data for public-sector organizations No Health Health Care Services
none Application - public sector Yes Yes Fillable Fileable Form Attachment 4A - DPRP application page (07.29.11).pptx 4a 4a Revised Yes Yes Fillable Fileable Form and instruction Att 4a_revised_DPRP Application Page updates.pdf
State, Local, and Tribal Governments 12 12 0

Application data for private-sector organizations No Health Health Care Services
none Att 4a - Application page Yes Yes Fillable Fileable Form Attachment 4A - DPRP application page (07.29.11).pptx
Private Sector 108 108 0

Evaluation data for public-sector organizations No Health Health Care Services
none Att 5a - Evaluation data elements Yes Yes Fillable Fileable Form and instruction Attachment 5A - Evaluation Data Elements (07.29.11).docx
State, Local, and Tribal Governments 48 48 0

Evaluation data for private-sector organizations No Health Health Care Services
none Att 5a - Evaluation data elements Yes Yes Fillable Fileable Form and instruction Attachment 5A - Evaluation Data Elements (07.29.11).docx
Private Sector 432 432 0

2012-03-08-05:00

0920-0910 201312-0920-001 0920
             
        "Testing and Evaluation of Tobacco Communication Activities"
             
          
        
The Center's for Disease Control and Prevention's Office on Smoking and Health (OSH) requests OMB approval of a revision to currnelty approved generic clearance to support a variety of information collections related to the development, implementation and evaluation of tobacco-related health messages and campaigns. 2015-01-31-05:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No Yes No 73694 14438 0

Digital Media Copy Testing for Click-to-Call Ads No Health Immunization Management Individuals or Households 2200 607 0

2014-01-02-05:00

0920-0912 201306-0920-010 0920
             
        "Frame Development for the National Survey of Long-Term Providers"
             
          
        
NCHS seeks approval to collect data needed to develop an up-to-date sampling frame of residential care facilities. The frame will be used to draw a nationally representative sample for a planned survey, the National Study of Long-Term Care Providers. 2016-07-31-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 102 88 0

Contact Information Verification No Health Immunization Management
none Contact Information Verification Yes Yes Fillable Fileable Form Attachment C 1-Advance Package Contact Info Verification.doc
State, Local, and Tribal Governments 34 3 0

Telephone Protocol No Health Immunization Management State, Local, and Tribal Governments 34 17 0

Electronic File Development No Health Immunization Management State, Local, and Tribal Governments 34 68 0

2013-07-25-04:00

0920-0913 201204-0920-004 0920
             
        "Evaluating Locally-Developed HIV Prevention Interventions for African-American MSM in Los Angeles"
             
          
        
This is a request to make minor changes to some of the forms based on feedback. 2015-01-31-05:00 Active Thelma Sims 4046394771 No No No 3984 1662 0

Outreach Recruitment Assessment No Health Public Health Monitoring Individuals or Households 700 58 0

Limited Locator Form No Health Public Health Monitoring Individuals or Households 700 58 0

Baseline Questionnaire No Health Public Health Monitoring Individuals or Households 528 528 0

Participant Contact Information Form No Health Public Health Monitoring Individuals or Households 528 88 0

Client Satisfaction Survey No Health Public Health Monitoring Individuals or Households 672 56 0

3-Month Follow-up Questionnaire No Health Public Health Monitoring Individuals or Households 420 420 0

6-Month Follow-up Questionnaire No Health Public Health Monitoring Individuals or Households 400 400 0

Success Case Study Interview No Health Public Health Monitoring Individuals or Households 36 54 0

2012-04-23-04:00

0920-0914 201306-0920-005 0920
             
        "Workplace Violence Prevention Programs In New Jersey Healthcare Facilities"
             
          
        
CDC's National Institute for Occupational Safety and Health (NIOSH) seeks clearance to conduct research on the prevention of workplace violence in the healthcare industry. The objective of this project is to evaluate the impact of the New Jersey Violence Prevention in Health Care Facilities Act. This revision request seeks approval to add the collection of data from nursing home administrators and home healthcare aides. 2016-02-29-05:00 Active Carol Walker 4046394773 No No No 2738 960 0

Hospital Administrators Evaluation Form No Health Public Health Monitoring
none Evaluation Form Yes No Fillable Fileable Form 10 7 2011attachment-C1.docx
Private Sector 17 17 0

Hospital Administrators Committee Chair Interview No Health Public Health Monitoring
none Interview Yes No Fillable Fileable Form 10 7 2011 attachment-C2.docx
Private Sector 17 17 0

Hospital Administrators Employee Incident Information No Health Public Health Monitoring
none Incident Information Yes No Fillable Fileable Form 10 7 2011 attachment-C3.docx
Private Sector 17 17 0

Nurse (RN and LPN) Survey No Health Public Health Monitoring
none Nurse Survey Yes Yes Fillable Fileable Form Appendix C4.doc
Individuals or Households 1333 444 0

Nursing Home Administrators Survey No Health Public Health Monitoring
none Nursing Home Administrators Survey Yes No Printable Only Form Appendix C1.docx
Individuals or Households 7 7 0

Nursing Home Administrators Committee Chair Interview No Health Public Health Monitoring Individuals or Households 7 7 0

Nursing Home Administrators Employee Incident Information No Health Public Health Monitoring
none Employee Incident Yes Yes Fillable Fileable Form Appendix C3.docx
Individuals or Households 7 7 0

Home Healthcare Aides Survey No Health Public Health Monitoring
none Home Healthcare Aide Survey Yes Yes Fillable Fileable Form Home Healthcare Aide Survey 6 7 2013.docx
Individuals or Households 1333 444 0

2013-06-19-04:00

0920-0915 201305-0920-007 0920
             
        "Formative Research to Support the Development of Sickle Cell Disease Educational Messages and Materials"
             
          
        
CDC seeks to improve the quality of life of people living with sickle cell disease (SCD). To accomplish this goal, CDC aims to address the need for educational messages and materials for adolescents, young adults, adults, and older adults living with SCD. CDC is interested in understanding the informational needs of these audiences related to the adoption of healthy behaviors and the prevention of complications associated with SCD. To develop these messages and materials, CDC will conduct formative focus groups with people with SCD across the country. 2014-06-30-04:00 Active Thelma Sims 4046394771 No No No 210 204 0

Participant Screener and Recruitment Form No Health Health Care Services Individuals or Households 120 24 0

Focus Group Moderator's Guide No Health Health Care Services Individuals or Households 90 180 0

2013-06-12-04:00

0920-0916 201302-0920-012 0920
             
        "Evaluation of Core Violence and Injury Prevention Program "
             
          
        
CDC is requesting a non-substantive change to this approved data collection which will allow more effective assessments for this program. The purpose of this ICR is to permit CDC to evaluate the Core VIPP program for the benefit of the Core VIPP grantees. This ICR has two overall goals: (1) to assess state injury and violence prevention plans for completeness, measurability, and effectiveness; and (2) evaluate the effectiveness of the Core VIPP cooperative agreement. Through the evaluation of the Core VIPP, CDC plans to improve state health department program and policy activities. The ultimate goal of the Core VIPP is to assist State Health Departments (SHDs) to build and/or maintain effective delivery systems for dissemination, implementation and evaluation of best practice programs and policies. This includes support for general capacity building of SHDs and their local partners, as well as strategy specific capacity building for the implementation of direct best practice interventions (older adult falls and child injury). 2014-02-28-05:00 Active Carol Walker 4046394773 No No No 156 284 0

Core VIPP Funded State Health Department--State of the States Survey No Health Health Care Services
1 State of the States Survey in PDF format Yes Yes Fillable Printable Form and instruction Attachment C-1 - PDF.pdf
State, Local, and Tribal Governments 28 84 0

Core VIPP Non-funded State Health Department State of the States Survey No Health Health Care Services
2 State of the States Survey in Word Format Yes No Fillable Fileable Form and instruction Attachment C-2 - WORD.docx
State, Local, and Tribal Governments 22 66 0

Core VIPP Funded SHD: Telephone Interview No Health Health Care Services State, Local, and Tribal Governments 28 42 0

Core VIPP Funded SHD: SOTS Financial Module No Health Health Care Services
3 Core VIPP Funded SHD: SOTS Financial Module Yes Yes Fillable Printable Form and instruction Attachment E-1 - PDF.pdf
State, Local, and Tribal Governments 28 28 0

Core VIPP Non-Funded SHD: SOTS Financial Module No Health Health Care Services
4 Core VIPP Non-Funded SHD: SOTS Financial Module Yes Yes Fillable Printable Form and instruction Attachment E-2 - WORD.docx
State, Local, and Tribal Governments 22 22 0

Supplemental SOTS Survey Questions No Health Health Care Services
none Mock-up Screen Shots Supplement SOTS Survey Yes Yes Fillable Fileable Form Attachment G - SOTS Supplement Screenshots.pdf
State, Local, and Tribal Governments 28 42 0

2013-02-15-05:00

0920-0919 201112-0920-014 0920
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery "
             
          
        
This collection of information is necessary to enable National Center on Birth Defects and Developmental Disabilities to garner customer and stakeholder feedback in an efficient and timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the Agency's programs. 2015-01-31-05:00 Active Daniel Holcomb dwh6@cdc.gov 770 488-4472 No No No 28000 18667 0

Customer Satisfaction Survey of Preconception Health Adcepts No Health Immunization Management
none Screener Yes Yes Fillable Fileable Form Attach 1_SCREENER.docx none Customer Service Survey Yes Yes Fillable Fileable Form Attach 2_CONCEPT TESTING SURVEY Updated 2-22-2012.doc
Individuals or Households 3200 375 0

Risk of Alcohol Use During Pregnancy: Message Testing and Materials Development No Health Immunization Management
1 Recruitment Screener for Focus Groups No No Paper Only Form and instruction Attch 1_Focus Group Participant Screener_Alcohol and Pregnancy Message Testing_01-23-12.docx No No Paper Only Other Attch 2_Focus Group Guide_Alcohol and Pregnancy Message Testing_01-23-12 (2).docx
Individuals or Households 480 207 0

English Language Folic Acid Educational Materials: Message Testing and Materials Development No Health Consumer Health and Safety
No No Paper Only Instruction Attachment 2 Moderators Guide.docx none Screener No No Paper Only Form Attachment 1 Screener.doc none Consent No No Paper Only Form Attachmnt 3 Consent Form.doc
Individuals or Households 480 160 0

Raising Public Awareness for Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) No Health Immunization Management
none Informed Consent Atlanta-evening Yes No Printable Only Form Att 11_Informed Consent_Atlanta-evening (rev).docx none Screener Atlanta Male 40-64 Yes No Fillable Fileable Form Att 2_Screener_2_Atlanta_Hospitalized-male_40-64_corrected 4_12_12.doc none Screener Atlanta Female 18-39 Yes No Fillable Fileable Form Att 1_Screener_1_Atlanta_Hospitalized-female_18-39_corrected4_12_12.doc none Screener Atlanta Male 65-80 Yes No Fillable Fileable Form Att 3_Screener_3_Atlanta_Hospitalized-male_65-80-seniors_corrected 4_12_12.doc none Screener Atlanta Female 40-64 Yes No Fillable Fileable Form Att 4_Screener_4_Atlanta_Hospitalized-female_40-64_corrected 4_12_12.doc none Screener Baltimore Female 18-39 Yes No Fillable Fileable Form Att 5_Screener_5_Baltimore_Hospitalized-female_18-39_corrected 4_12_12.doc none Screener Baltimore Male 18-39 Yes No Fillable Fileable Form Att 6_Screener_6_Baltimore_Hospitalized-male-18-39_corrected 4_12_12.doc none Screener Baltimore Female 65-80 Yes No Fillable Fileable Form Att 7_Screener_7_Baltimore_Hospitalized-female_65-80-seniors_corrected 4_12_12.doc none Screener Baltimore Male 40-64 Yes No Fillable Fileable Form Att 8_Screener_8_Baltimore_Hospitalized-male_40-64_corrected4_12_12.doc none Rescreener Yes No Fillable Fileable Form Att 9_Rescreener_Hospitalized_3 26 12Final.docx none Informed Consent Atlanta Yes No Fillable Printable Form Att 10_Informed Consent_Atlanta (rev).docx none Informed Consent Baltimore No No Printable Only Form Att 12_Informed Consent_Baltimore (rev).docx none Focus Group Discussion Guide Yes No Printable Only Form Att 13_DVT MT Discussion Guide.docx
Individuals or Households 360 148 0

ADDM Network: Communication Materials Testing and Development No Health Immunization Management Individuals or Households 30 23 0

Materials Testing to Develop and Enhance Recruitment Material for SEED - phase 2 No Health Consumer Health and Safety Individuals or Households 30 30 0

Exploration of Distribution and Reach of Educational Children's Book Amazing Me- It's Busy Being 3! In Pediatric Office Settings No Health Immunization Management
None Amazing Me-It's Busy 3! Book Survey No No Fillable Fileable Form and instruction Attach A1_ Amazing Me Task 2 Online Clinic Tracking Survey_FINAL_10-26-12.docx
Private Sector 575 32 0

Disability and Health Data System User Feedback Survey No Health Immunization Management
None DHDS User Feedback Survey Yes Yes Fillable Printable Form and instruction Att 1_UserSurveyQuestions_(word).docx none DHDS User Feedback Survey Yes Yes Fillable Fileable Form and instruction Att 1a_ UserSurveyQuestions_(screenshots).docx
State, Local, and Tribal Governments 200 17 0

DHDD Continuous Quality Improvement Surveys for State and National PHPRC Disability and Health Coordinators No Health Public Health Monitoring
none Post Evaluation Webinar Yes Yes Fillable Fileable Form Att 9_PostEvalWebinarSurvey.docx none Disability and Health Interventions Yes Yes Fillable Fileable Form Att 10_DisabilityInterventions.docx none Disability and Health Branch Site Visit Yes Yes Fillable Fileable Form Att 11_SiteVisitEval.docx none Resource Center Eval Think Tank Yes Yes Fillable Fileable Form Att 8_RETTGroupFeedbackScreenshots.docx none State Evaluation Think Tank Group Feedback Yes Yes Fillable Fileable Form Att 7_SETTGrpFeedback.docx none State Evaluation Think Tank Yes Yes Fillable Fileable Form Att 6_SETTGrpCall.docx none Resource Center Evaluation Yes Yes Fillable Fileable Form Att 5_RETTConferenceCallScreenshots.docx none Workplan Feedback Survey Yes Yes Fillable Fileable Form Att 4_ElectronicWorkplan.docx none Monthly Conference Call Evaluation Yes Yes Fillable Fileable Form Att 3_MonthlyConfCallEval.docx none Interim Progress Report Yes Yes Fillable Fileable Form Att 2_ElectronicIPR.docx none Annual Grantee Meeting Survey Yes Yes Fillable Fileable Form Att 1_AnnualMtgIdeaGenSurv.docx
State, Local, and Tribal Governments 404 85 0

Pilot Messaging Campaign Follow-up Survey No Health Health Care Services
none Customer Satisfaction Survey-Pilot Messaging Campaign Follow-up Survey Yes Yes Fillable Fileable Form Att 1_Flu video survey screenshot.pptx
Private Sector 65 5 0

2012-01-30-05:00

0920-0920 201209-0920-006 0920
             
        "Data Collection Through Web Based Surveys for Evaluating Act Against AIDS Social Marketing Campaign Phases Targeting Consumers"
             
          
        
CDC requests to make a change to the parties responsible for data collection under this generic clearance; allowing RTI International and other panel vendors to recruit for and conduct web-based surveys under this generic clearance. This request is also for a change in frequency of data collection from quarterly to varied. 2015-02-28-05:00 Active Carol Walker 4046394773 No No No 72000 8001 0

HIV Prevention and Testing Messages for Act Against AIDS Social Marketing Campaigns Targeting Gay/Bisexual Men No Health Immunization Management
none Att 2 - Survey Instrument Yes Yes Fillable Fileable Form Attachment 2_Web-based Survey Instrument.pdf none Att 3 - Screener Yes Yes Fillable Fileable Form Attachment 3_Web-based Survey Screener.pdf
Individuals or Households 1283 299 0

African American Women's Perceptions of a Social Marketing Campaign to Promote HIV Testing No Health Immunization Management
none Screener Yes Yes Fillable Fileable Form Att 3_ Screener.pdf none Survey Yes Yes Fillable Fileable Form Att 2_Survey_07-03-2013.pdf
Individuals or Households 466 109 0

Message Testing for the AAA Campaign - Hispanics/Latinos No Health Immunization Management
0920-0920 Attachment 2_Web-based Screener_Eng Yes Yes Fillable Fileable Form and instruction Attachment 2_Web-based Screener_Eng.docx 0920-0920 Message Testing for the AAA Campaign - Hispanics/Latinos Yes Yes Fillable Printable Form and instruction Attachment 1A_Web-based Survey_Spn.docx 0920-0920 Attachment 1 Message Testing for the AAA Campaign - HispanicsLatinos Yes Yes Fillable Fileable Form and instruction Attachment 1 Message Testing for the AAA Campaign - HispanicsLatinos.docx 0920-0920 Attachment 2A_Web-based Screener_Spn Yes Yes Fillable Fileable Form and instruction Attachment 2A_Web-based Screener_Spn.docx
Individuals or Households 1170 272 0

2012-09-24-04:00

0920-0922 201112-0920-015 0920
             
        "Monitoring Outcomes of the Enhanced Comprehensive HIV Prevention Plan (ECHPP) Project"
             
          
        
This data collection activity will assist with the ECHPP evaluation. This data collection activity will occur in six of the 12 ECHPP MSAs. This activity is designed to monitor community-level outcomes of ECHPP in these MSAs and supplement existing HIV surveillance data that are already being collected via CDC data systems in these cities. 2015-02-28-05:00 Active Catina Conner 4046394775 No No No 7040 1704 0

Project Orientation - Clinic Staff No Health Immunization Management Private Sector 40 20 0

Clinic Staff Provision Patient of Loads No Health Immunization Management Private Sector 600 50 0

Clinic Staff Script - Approaching Clients No Health Immunization Management Private Sector 1100 92 0

Clinic Screener - HIV Positive Screened Individuals No Health Immunization Management Private Sector 1400 117 0

Clinic Survey - Eligible HIV-positive Individuals No Health Immunization Management Private Sector 1200 800 0

Community Screener - Screened Injection Drug Users and High-risk heterosexual individuals No Health Immunization Management Private Sector 1500 125 0

Community Survey - Eligible Injection Drug Users No Health Immunization Management Private Sector 600 250 0

Community Survey - Eligible High-Risk Heterosexual Individuals No Health Immunization Management Private Sector 600 250 0

2012-02-15-05:00

0920-0923 201306-0920-008 0920
             
        "Evaluation of the National Tobacco Prevention and Control Public Education Campaign"
             
          
        
In 2012, CDC's Office on Smoking and Health (OSH) conducted baseline and follow-up surveys to assess awareness of and exposure to tobacco education advertisements that were launched in the Tips from Former Smokers campaign (TIPS Phase 1). New ads will be fielded in 2013 (TIPS Phase 2). CDC requests OMB approval conduct an additional follow-up survey in 2013. 2014-04-30-04:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No Yes No 61273 8765 0

Screening and Consent Process (Phase 2Survey) No Health Immunization Management
None Evaluation of the National Tobacco Prevention and Control Public Education Screening Questionnaire Yes Yes Fillable Printable Form and instruction Att E-1. Revised Screener 6-11-13.docx
Individuals or Households 43737 1458 0

2013 Smoker Follow-up Questionnaire (Phase 2) No Health Immunization Management
None CDC National Media Campaign--Revised Smoker Questionnaire Yes Yes Fillable Printable Form Att C-2a. Revised Smoker wave 3 survey 6-11-13.docx
Individuals or Households 14250 5938 0

2013 Non-Smoker Follow-up Questionnaire (Phase 2) No Health Immunization Management
None CDC National Media Campaign Evaluation--Revised Non-Smoker Questionnaire Yes Yes Fillable Printable Form Att D-2a. Revised Nonsmoker Follow-up Survey_6-11-13.docx
Individuals or Households 3286 1369 0

2013-06-28-04:00

0920-0925 201204-0920-002 0920
             
        "Children's Health after the Storms (CHATS)"
             
          
        
This request for change to CHATS is to provide the Spanish and Vietnamese translations for the project and new outreach materials. There is no change in burden or respondents. 2015-03-31-04:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 3178 1310 0

Eligibillity Screener No Health Immunization Management
none CHATS Attachment K_revised_02272012 Yes Yes Fillable Fileable Form CHATS Attachment K_revised_02272012.docx
Individuals or Households 1118 186 0

Baseline: Session 1 (Child Modules) No Health Immunization Management
none CHATS Attachment L_revised_02272012 Yes Yes Fillable Fileable Form and instruction CHATS Attachment L_revised_02272012.docx
Individuals or Households 250 63 0

Baseline: Session 1 (Parent Modules) No Health Immunization Management
none CHATS Attachment L_revised_02272012 Yes Yes Fillable Fileable Form and instruction CHATS Attachment L_revised_02272012.docx
Individuals or Households 250 250 0

Baseline: Session 2 (Child Modules) No Health Immunization Management
none CHATS Attachment M_revised_02272012 No No Fillable Fileable Form and instruction CHATS Attachment M_revised_02272012.docx
Individuals or Households 250 250 0

Baseline: Session 2 (Parent Modules) No Health Immunization Management
none CHATS Attachment M_revised_02272012 Yes Yes Fillable Fileable Form and instruction CHATS Attachment M_revised_02272012.docx
Individuals or Households 250 125 0

6-Month Follow-up: Session 1 (Child Modules) No Health Immunization Management
none CHATS Attachment N_revised_02272012 Yes Yes Fillable Fileable Form and instruction CHATS Attachment N_revised_02272012.docx
Individuals or Households 225 26 0

6-Month Follow-up: Session 1 (Parent Modules) No Health Immunization Management
none CHATS Attachment N_revised_02272012 Yes Yes Fillable Fileable Form and instruction CHATS Attachment N_revised_02272012.docx
Individuals or Households 225 150 0

6-Month Follow-up: Session 2 (Child Modules) No Health Immunization Management
none CHATS Attachment O_revised_02272012 Yes Yes Fillable Fileable Form and instruction CHATS Attachment O_revised_02272012.docx
Individuals or Households 225 139 0

6-Month Follow-up: Session 2 (Parent Modules) No Health Immunization Management
none CHATS Attachment M_revised_02272012 Yes Yes Fillable Fileable Form and instruction CHATS Attachment M_revised_02272012.docx
Individuals or Households 225 113 0

Verification Quesionnaire for Eligibility Screener (10% subsample) No Health Immunization Management
none Verification for Screener Yes Yes Fillable Fileable Form Attachment P .docx
Individuals or Households 112 4 0

Verification Questionnaire for Baseline and 6-Month Follow-up Visits (9% subsample) No Health Immunization Management
none Verification for Interview Yes Yes Fillable Fileable Form Attachment Q.docx
Individuals or Households 43 4 0

Mail Verification Form for Baseline and 6-Month Fllow-up Visits (1% subsample) No Health Immunization Management
none Mail Verification for Interview Yes No Paper Only Form Attachment R.docx
Individuals or Households 5 0 0

2012-05-07-04:00

0920-0927 201201-0920-009 0920
             
        "Pre-Evaluation Assessments of Nutrition, Physical Activity and Obesity Programs and Policies"
             
          
        
CDC will collect information to identify promising community-based strategies to prevent obesity by improving nutrition and physical activity. Program strategies selected for assessment must be based on CDC guidance. 2014-03-31-04:00 Active Petunia Gissendaner 4046390164 No No No 231 291 0

Nomination No Health Immunization Management
2 Nutrition and Physical Activity Initiatives to Prevent Obesity Yes Yes Fillable Printable Form and instruction Att 4B_Program Nomination form web-based screenshots.pdf 1 Nutrition and Physical Activity Initiatives to Prevent Obesity Yes Yes Paper Only Form and instruction Att 4A_PROGRAM NOMINATION FORM - hardcopy.doc
State, Local, and Tribal Governments 51 51 0

Lead Administrator Interview Guide No Health Immunization Management State, Local, and Tribal Governments 12 24 0

Lead Administrator--Suggested Interviewees Form No Health Immunization Management
4 Suggested Interviewees Form Yes Yes Paper Only Form and instruction Att 5B_Suggested Interviewees Form.doc
State, Local, and Tribal Governments 12 12 0

Evaluator Interview No Health Immunization Management State, Local, and Tribal Governments 12 12 0

Program Staff Interview No Health Immunization Management State, Local, and Tribal Governments 36 36 0

Public Sector Partner Interviews No Health Immunization Management State, Local, and Tribal Governments 48 48 0

Private Sector Partner Interviews No Health Immunization Management State, Local, and Tribal Governments 36 36 0

Lead Administrator -- Site Visit Availability Calendar No Health Immunization Management
2 Site Visit Availability Calendar No No Paper Only Form Att 5A_Site Visit Availability Calendar.doc
State, Local, and Tribal Governments 12 12 0

Lead Administrator Site Visit Schedule and Intructions No Health Immunization Management
3 Site Visit Schedule Instructions and Template Yes Yes Fillable Printable Form and instruction Att 5E_Site Visit Instructions and Template.doc
State, Local, and Tribal Governments 12 60 0

2012-03-30-04:00

0920-0928 201112-0920-011 0920
             
        "Web-based HIV Behavioral Survey among Men who have Sex with Men"
             
          
        
CDC has received funding from the Affordable Care Act's Prevention and Public Health Fund to conduct an annual, national, web-based behavioral suvey to monitor HIV risk behavior and exposure to prevention services among internet-using MSM. Data will be collected in 56 jurisdictions and 21 MSAs with the highest AIDS prevalence in the US. The data will enhance CDC's ability to monitor national trends in HIV and direct HIV prevention programs and policies. 2015-03-31-04:00 Active Daniel Holcomb dwh6@cdc.gov 770 488-4472 No Yes No 479090 44819 0

Eligibility Screener No Health Immunization Management
none Screener Yes Yes Fillable Fileable Form Att 2a Eligibility Screener.docx none Screener - Spanish version Yes Yes Fillable Fileable Form Att 3a Eligibility Screener (Spanish).docx
Individuals or Households 309090 5152 0

Behavioral Assessment No Health Immunization Management
none Behavioral Assessment - Spanish version Yes Yes Fillable Fileable Form Att 3b Behavioral Assessment Survey (Spanish).docx none Behavioral Assessment Survey (English) Yes Yes Fillable Fileable Form Att 2b Behavioral Assessment Survey.docx
Individuals or Households 170000 39667 0

2012-03-30-04:00

0920-0929 201201-0920-011 0920
             
        "World Trade Center Health Program Petition for the Addition of a New WTC-Related Health Condition for Coverage under the World Trade Center (WTC) Health Program"
             
          
        
Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. Sections 3311, 3312, and 3321 of Title XXXIII of the PHS Act require that the WTC Program Administrator develop regulations to implement portions of the WTC Health Program established within the Department of Health and Human Services (HHS). The WTC Health Program is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC). The Zadroga Act requires that the Program accept petitions from interested parties to add a health condition to the list of WTC-related health conditions in 42 CFR ?88.1. The information provided with this form and supporting documentation will be used by the WTC Program Administrator to consider the disposition of a petitioned-for health condition. Disclosure of this information is voluntary. 2015-04-30-04:00 Active Petunia Gissendaner 4046390164 No No No 100 4000 0

Petition for the Addition of a New WTC-Related Health Condition for Coverage under the World Trade Center (WTC) Health Program No Health Public Health Monitoring
1 Petition for the Addition of a New WTC-Related Health Condition for Coverage under the World Trade Center (WTC) Health Program Yes No Paper Only Form and instruction Attachment C_Petition for the Addition of a New WTC-Related Health Condition.pdf
Individuals or Households 100 4000 0

2012-04-18-04:00

0920-0930 201204-0920-001 0920
             
        "Measuring Preferences for Quality of Life for Child Maltreatment"
             
          
        
The US Department of Health and Human Services, among many others, has identified child maltreatment as a serious U.S. public health problem with substantial long-term physical and psychological consequences. Despite considerable qualitative research on the consequences of CM in adults, few studies have utilized standardized HRQOL techniques and none have quantified childhood HRQOL impacts. This gap in the literature means the full burden of CM on HRQOL has not been measured, inhibiting the evaluation of CM intervention programs and comparisons to other public health issues. This exploratory research study will improve public health knowledge and economic evaluation of the HRQOL impacts of CM, including effects specific to juvenile and adolescent victims, through the development and fielding a preference-based survey instrument. CDC has developed an exploratory survey instrument to quantify the HRQOL impacts of child maltreatment following standardized HRQOL methods. The survey was developed based on findings from a literature review of CM outcomes, focus groups with adults who were CM victims, and expert review of outcomes by clinician consultants who work with children and/or adults who were victims of CM, or who are researchers in the field of CM. The survey is designed to quantify two types of data. The main objective is the HRQOL decrement attributable to CM, measured as the difference in HRQOL scores by CM victimization history. A secondary objective is a statistical evaluation of these decrements, based on respondent preferences over a series of comparisons that will be shown to survey respondents. 2014-04-30-04:00 Active Petunia Gissendaner 4046390164 No No No 1850 771 0

Measuring Preferences for Quality of Life for Child Maltreatment Survey Instrument: Ages 18-29 No Health Health Care Services
Attachment D Childhood Experiences Survey Yes Yes Fillable Fileable Form and instruction Attachment D - Survey Instrument 3-29-2012.docx
Individuals or Households 750 313 0

Measuring Preferences for Quality of Life for Child Maltreatment Survey Instrument: Ages 18+ No Health Health Care Services
Attachment D Childhood Experiences Survey Yes Yes Fillable Fileable Form and instruction Attachment D - Survey Instrument 3-29-2012.docx
Individuals or Households 1100 458 0

2012-04-23-04:00

0920-0931 201111-0920-005 0920
             
        "The Healthy Homes Lead Poisoning Surviellance System (HHLPSS)"
             
          
        
The Healthy Homes Lead Poisoning Surveillance System (HHLPSS) builds upon previous efforts by the National Blood Lead Surveillance System (NBLSS) to characterize the home environment in terms of not only lead poisoning risk factors, but also other home-based risk factors. 2015-04-30-04:00 Active Catina Conner 4046394775 No No No 160 640 0

Healthy Homes and Lead Poisoning Surveillance Variables No Health Public Health Monitoring State, Local, and Tribal Governments 160 640 0

2012-04-23-04:00

0920-0932 201203-0920-007 0920
             
        "Data Collection for Evaluation of Education, Communication, and Training Activities"
             
          
        
This is generic request for Evaluating Education, Communication, and Training Activities within the National Center for Emerging and Zoonotic Infectious Disease's Division of Global Migration and Quarantine Division (DGMQ). 2015-05-31-04:00 Active Petunia Gissendaner 4046390164 No No No 166500 66498 0

Evaluation of Adapted Health Education Materials for LEP Spanish-Speakers and Indigenous Migrants No Health Immunization Management
Yes No Fillable Printable Other Attachment C- Indigenous TB Discussion Guide.docx Yes No Fillable Printable Other Attachment E-Indigenous Flu Discussion Guide.docx Yes No Fillable Printable Other Attachment D- LEP Flu Discussion Guide.docx Yes No Fillable Printable Other Attachment B-LEP TB QF Discussion Guide.docx none Screener Yes No Fillable Printable Form Attachment F- Participant Screener.docx
Individuals or Households 480 373 0

Evaluating the Effectiveness of Quick Response Codes in Educating Panel Physicians No Health Consumer Health and Safety
None Statement of Consent for Pre-Knowledge Aptitude Survey Yes Yes Fillable Fileable Form and instruction Attachment A(1)--Screen Shot of Web-Based Pre-Knowledge Survey.docx Yes No Paper Only Other Attachment A(3)--In-Depth Interview Guide rev.docx None Statement of Consent for Semi-Structured Aptitude Questionnaire Yes Yes Fillable Fileable Form and instruction Attachment A(2)--Screen Shot of Web-Based Semi-Structured Questionnaire.docx
Private Sector 210 71 0

2012-05-07-04:00

0920-0933 201201-0920-001 0920
             
        "Asthma Education Study:  Making Health Care Providers Better Asthma Educators"
             
          
        
Close to 25 million Americans currently suffer with asthma, with 12 million experiencing an asthma "attack" in 2009, costing the nation $56 billion and individuals on average over $3,200 annually in direct and indirect costs. Improved self-management education, consistent with the National Asthma Education and Prevention Program (of the National Heart, Lung, and Blood Institute) Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (2007) for enhancing education of persons with asthma in the areas of correct medication adherence and avoidance of environmental triggers of asthma attacks, is central to reducing the health and financial burden on individuals and the nation. This research is an important step in improving the education individuals with asthma (or parents of children with asthma) receive at their initial diagnosis encounter with the medical system. 2015-05-31-04:00 Active Thelma Sims 4046394771 No No No 96 40 0

Physician Screener No Health Consumer Health and Safety Private Sector 24 2 0

Nurse Screener No Health Consumer Health and Safety Private Sector 24 2 0

Moderator's Guide for In-depth Interviews of Physicians No Health Consumer Health and Safety Private Sector 24 12 0

Moderator's guide for Focus Groups with Nurses No Health Consumer Health and Safety Private Sector 24 24 0

2012-05-07-04:00

0920-0935 201205-0920-007 0920
             
        "National Survey of Prison Health Care (NSPHC)"
             
          
        
The National Survey of Prison Health Care (NSPHC) will be a semi-structured telephone survey with a prison official in the Department of Corrections (DOC) in the 50 States and Federal Bureau of Prisons (BOP) and will seek facility-level information on the types of healthcare services delivered and the mechanisms used to deliver them. The goals of this survey include to: Collect data that will provide an overall picture of the structure of U.S. prison health care delivery systems; and assess the quality of the data collected. NSPHC will collect data on how DOCs maintain health records including the format (paper and/or electronic) of specific types of health records. 2014-06-30-04:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 51 204 0

National Survey of Prison Health Care Interview Guide No Health Health Care Services
none NSPHC Interview Guide No No Paper Only Form Attachment F NSPHC Interview Guide.doc
State, Local, and Tribal Governments 51 204 0

2012-06-01-04:00

0920-0937 201203-0920-005 0920
             
        "Community Transformation Grants:  Use of System Dynamics Modeling and Economic Analysis in Select Communities"
             
          
        
CDC plans to collect cost data from 30 Community Transformation Grant (CTG) awardees. Information will be analyzed to estimate the direct costs associated with particular community intervention approaches implemented with CTG funding. 2015-06-30-04:00 Active Thelma Sims 4046394771 Yes Yes No 480 6240 0

CTG Cost Study Instrument (CTG-CSI) No Health Immunization Management State, Local, and Tribal Governments 480 6240 0

2012-06-04-04:00

0920-0938 201202-0920-005 0920
             
        "Underreporting of Occupational Injuries and Illnesses by Workers"
             
          
        
The data collected through these interviews will allow estimation of injuries and illnesses among workers excluded from other national occupational injury surveillance, provide a better understanding of injury reporting issues directly from the worker's perspective, and provide new data on the chronic aspects of occupational injuries and illnesses. 2015-06-30-04:00 Active Petunia Gissendaner 4046390164 No No No 3000 1500 0

Underreporting of Occupational Injuries and Illness by Workers No Health Immunization Management
1 NIOSH Congressional Under-Reporting Questionnaire Yes No Paper Only Form App F Injuries 2012_01_26.docx 2 NIOSH Congressional Under-Reporting Questionnaire--Spanish Version Yes No Paper Only Form App G Congressional Questionnaire Spanish 2012_01_26.docx
Individuals or Households 3000 1500 0

2012-06-04-04:00

0920-0939 201201-0920-008 0920
             
        "Barriers to Occupational Injury Reporting by Workers: A NEISS Telephone Interview Survey"
             
          
        
The NEISS occupational supplement (NEISS-Work) and injury supplement (NEISS-AIP) are collected by the Consumer Product Safety Commission and capture people who were treated in emergency departments for work-related and non-work-related injuries. This project will uses cases from these supplements to identify potential participants for a phone interview of employed persons to assess incentives and disincentives to reporting work-related injuries. 2014-06-30-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 600 300 0

Barriers to occupational injury reporting by workers No Health Consumer Health and Safety
None Appendix D Barriers to Reporting Questionnaire Yes Yes Fillable Fileable Form AppD Barriers to Reporting Questionnaire_120502.docx
Individuals or Households 600 300 0

2012-06-04-04:00

0920-0940 201205-0920-005 0920
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIOSH)"
             
          
        
This collection of information is necessary to enable the Agency to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the Agency's programs. 2015-06-30-04:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 1000 800 0

Usability Testing of HHE Program Webpages for Employers/Employees via Remote and In-person Testing No Workforce Management Worker Safety
None Appendix B: Usability Testing Participant Screener for RemoteTesting Yes Yes Fillable Fileable Form and instruction Appendix B- Usability Testing 3.8.13.docx None Appendix A: Usability Testing Participant Screener for In-Person Testing Yes Yes Fillable Fileable Form and instruction Appendix A- In-person testing 3 8 13.docx Yes Yes Printable Only Instruction Task C Testing Plan with comments 3.8.13.docx
Private Sector 10 10 0

Material Testing of Health Hazard Evaluation Program Investigation Reports No Workforce Management Worker Safety Private Sector 81 90 0

Focus Group Testing of Two Health Hazard Evaluation Program Brochures No Workforce Management Worker Safety
none Focus Group Guide Yes No Fillable Printable Form Task A Appendix B.docx none Telephone Screener Yes Yes Fillable Printable Form Task A Appendix A (2).docx
Individuals or Households 90 64 0

2012-06-21-04:00

0920-0941 201309-0920-005 0920
             
        "Evaluation of Dating Matters: Strategies to Promote Healthy Teen Relationships"
             
          
        
Dating Matters is a comprehensive approach to prevent teen dating violence among youth in high-risk urban communities. Dating Matters consists of evidence-based or evidence-informed prevention strategies implemented at each level of the social ecology. Changes requested are to amend the student follow-up survey with questions that will be relevant to participating youth as they matriculate into high school. 2016-05-31-04:00 Active Petunia Gissendaner 4046390164 No No No 52897 28814 0

Student Outcome Survey Baseline No Health Health Care Services
None Student Outcome Survey Baseline No No Paper Only Form and instruction Atmt_D_Student_Outcome_Survey_Baseline_corrected[1].doc
Individuals or Households 11286 8465 0

Student Outcome Survey Follow-up - High School No Health Health Care Services
none Student Outcome Survey Yes No Fillable Printable Form Atmt_E_Student_Outcome_Survey_HIGH SCHOOL Follow-Up_9.4.13 final.doc
Individuals or Households 10692 8910 0

School Indicators No Health Health Care Services
4 Attachment G: School Indicators No No Paper Only Form and instruction Atmt G Parent Outcome Survey School Indicators.docx
Individuals or Households 15048 3762 0

Parent Outcome Baseline Survey No Health Health Care Services
none Parent/Guardian Survey Yes No Paper Only Form and instruction Attachment H - Educator+Outcome+Survey.docx
Individuals or Households 1919 1919 0

Parent Outcome Follow-up Survey No Health Health Care Services
none Parent/Guardian Consent Form No No Paper Only Form and instruction Attachment VV - Parent+Consent+for+Parent+Form.docx None Parent Outcome Survey Follow-up Yes Yes Fillable Fileable Form and instruction Atmt EEEE - Parent_Outcome_Survey_Follow-Up.doc
Individuals or Households 1818 1818 0

Educator Outcome Survey Baseline No Health Health Care Services
None Educator Outcome Survey (Baseline) No No Paper Only Form and instruction Atmt_I_Educator_Outcome_Survey_Baseline[1].docx
Individuals or Households 1672 836 0

Brand Ambassador Implementation Survey No Health Health Care Services
None Brand Ambassador Implementation Survey No No Paper Only Form and instruction Atmt_J_Brand_Ambassador_Implementation_Survey[1].docx
Individuals or Households 160 53 0

School Leadership Capacity and Readiness Survey No Health Health Care Services
None School Leadership Capacity and Readiness Survey Yes Yes Fillable Fileable Form and instruction Atmt_K_School_Leadership_Capacity_and_Readiness_Assessment[1].docx
Individuals or Households 42 42 0

Parent Program Fidelity 6th Grade Sessions 1-6 No Health Health Care Services
L Parent Program Fidelity 6th Grade Session 2 No No Paper Only Form Atmt L ParentProgram6thgradeFidelitySession1.docx M Parent Program Fidelity 6th Grade Session 2 No No Paper Only Form Atmt M ParentProgram6thgradeFidelitySession2.docx N Parent Program Fidelity 6th Grade Session 3 No No Paper Only Form Atmt N ParentProgram6thgradeFidelitySession3.docx O Parent Program Fidelity 6th Grade Session 5 No No Paper Only Form Atmt O ParentProgram6thgradeFidelitySession4.docx Q Parent Program Fidelity 6th Grade Session 6 No No Paper Only Form Atmt Q ParentProgram6thgradeFidelitySession6.docx
Individuals or Households 630 158 0

Parent Program Fidelity 7th Grade Sessions 1, 3, 5 No Health Health Care Services
T Parent Program Fidelity 7th Grade Session 5 No No Paper Only Form Atmt T Parent Program 7th Grade Session 5.docx R Parent Program Fidelity 7th Grade Session 1 No No Paper Only Form Atmt R Parent Program 7th Grade Session 1.docx S Parent Program Fidelity 7th Grade Session 3 No No Paper Only Form Atmt S Parent Program 7th Grade Session 3.docx
Individuals or Households 378 95 0

Student Program Fidelity 6th Grade Sessions 1 - 6 No Health Health Care Services
V Student Program Fidelity 6th Grade Session 2 No No Paper Only Form and instruction Atmt V StudentProgram6thGrade_Session2.docx W Student Program Fidelity 6th Grade Session 3 No No Paper Only Form and instruction Atmt W StudentProgram6thGrade_Session3.docx U Student Program Fidelity 6th Grade Session 1 No No Paper Only Form and instruction Atmt U StudentProgram6thGrade_Session1.docx X Student Program Fidelity 6th Grade Session 4 No No Paper Only Form and instruction Atmt X StudentProgram6thGrade_Session4.docx Y Student Program Fidelity 6th Grade Session 5 No No Paper Only Form and instruction Atmt Y StudentProgram6thGrade_Session5.docx Z Student Program Fidelity 6th Grade Session 6 No No Paper Only Form and instruction Atmt Z StudentProgram6thGrade_Session6.docx
Individuals or Households 480 120 0

Student Program Fidelity 7th Grade Sessions 1 - 7 No Health Health Care Services
BB Student Program Fidelity 7th Grade Session 2 No No Paper Only Form and instruction Atmt BB StudentProgram 7th Grade Session 2.docx CC Student Program Fidelity 7th Grade Session 3 No No Paper Only Form and instruction Atmt CC Student Program 7th Grade Session 3.docx DD Student Program Fidelity 7th Grade Session 4 No No Paper Only Form and instruction Atmt DD StudentProgram 7th Grade Session 4.docx EE Student Program Fidelity 7th Grade Session 5 No No Paper Only Form and instruction Atmt EE StudentProgram 7th Grade Session 5.docx FF Student Program Fidelity 7th Grade Session 6 No No Paper Only Form and instruction Atmt FF StudentProgram 7th Grade Session 6.docx GG Student Program Fidelity 7th Grade Session 7 No No Paper Only Form and instruction Atmt GG StudentProgram 7th Grade Session 7.docx AA Student Program Fidelity 7th Grade Session 1 No No Paper Only Form and instruction Atmt AA StudentProgram 7th Grade Session 1.docx
Individuals or Households 560 140 0

Student Program Fidelity 8th Grade Sessions 1 - 10 No Health Health Care Services
MM Student Program Fidelity 8th Grade Session 6 No No Paper Only Form and instruction Atmt MM SafeDatesCompSession6.docx NN Student Program Fidelity 8th Grade Session 7 No No Paper Only Form and instruction Atmt NN SafeDatesCompSession7.docx OO Student Program Fidelity 8th Grade Session 8 No No Paper Only Form and instruction Atmt OO SafeDatesCompSession8.docx PP Student Program Fidelity 8th Grade Session 9 No No Paper Only Form and instruction Atmt PP SafeDatesCompSession9.docx QQ Student Program Fidelity 8th Grade Session 10 No No Paper Only Form and instruction Atmt QQ SafeDatesCompSession10.docx KK Student Program Fidelity 8th Grade Session 4 No No Paper Only Form and instruction Atmt KK SafeDatesCompSession4.docx LL Student Program Fidelity 8th Grade Session 5 No No Paper Only Form and instruction Atmt LL SafeDatesCompSession5.docx HH Student Program Fidelity 8th Grade Session 1 No No Paper Only Form and instruction Atmt HH SafeDatesCompSession1.docx II Student Program Fidelity 8th Grade Session 2 No No Paper Only Form and instruction Atmt II SafeDatesCompSession2.docx JJ Student Program Fidelity 8th Grade Session 3 No No Paper Only Form and instruction Atmt JJ SafeDatesCompSession3.docx
Individuals or Households 800 200 0

Communications Campaign Tracking No Health Health Care Services
None Communications Campaign Tracking Form No No Paper Only Form and instruction Atmt_RR_Communications_Campaign_Tracking[1].docx
Individuals or Households 16 5 0

Local Health Department Capacity and Readiness No Health Health Care Services
None Local Health Department Capacity and Readiness Yes Yes Fillable Fileable Form Atmt_SS_Local_Health_Department_Capacity_and_Readiness_Survey[1].docx
Individuals or Households 16 32 0

Student Participant Focus Group No Health Health Care Services Individuals or Households 80 120 0

Student Curricula Implementer Focus Group Guide No Health Health Care Services
No No Paper Only Other Atmt AAA Student Curricula Implementer Focus Group Guide_10-31-11.docx OOO Student Curricula Implementer Consent Form For Focus Group Participation No No Paper Only Form and instruction Atmt OOO Student curricula implementer consent for focus group participation_10-25-11.docx
Individuals or Households 80 80 0

Parent Curricula Implementer Focus Group Guide No Health Health Care Services
No No Paper Only Other Atmt BBB Parent Curricula Implementer Focus Group Guide_10-31-11.docx PPP Parent Curricula Implementer Consent Form for Focus Group Participation No No Paper Only Form and instruction Atmt PPP Parent curricula implementer consent for focus group participation_10-25-11.docx
Individuals or Households 80 80 0

Student Program Fidelity 8th Grade Sessions 1 - 10 (Standard) No Health Health Care Services
KKK Student Program Fidelity 8th Grade Session 9 No No Paper Only Form and instruction Atmt KKK SafeDatesStandardSession9.docx JJJ Student Program Fidelity 8th Grade Session 8 No No Paper Only Form and instruction Atmt JJJ SafeDatesStandardSession8.docx LLL Student Program Fidelity 8th Grade Session 10 No No Paper Only Form and instruction Atmt LLL SafeDatesStandardSession10.docx GGG Student Program Fidelity 8th Grade Session 5 No No Paper Only Form and instruction Atmt GGG SafeStandardCompSession5.docx DDD Student Program Fidelity 8th Grade Session 2 No No Paper Only Form and instruction Atmt DDD SafeDatesStandardSession2.docx EEE Student Program Fidelity 8th Grade Session 3 No No Paper Only Form and instruction Atmt EEE SafeDatesStandardSession3.docx CCC Student Program Fidelity 8th Grade Session 1 (Standard) No No Paper Only Form and instruction Atmt CCC SafeDatesStandardSession1.docx FFF Student Program Fidelity 8th Grade Session 4 No No Paper Only Form and instruction Atmt FFF SafeDatesStandardSession4.docx HHH Student Program Fidelity 8th Grade Session 6 No No Paper Only Form and instruction Atmt HHH SafeDatesStandardSession6.docx III Student Program Fidelity 8th Grade Session 7 No No Paper Only Form and instruction Atmt III SafeDatesStandardSession7.docx
Individuals or Households 800 200 0

STUDENT PROGRAM MASTER TRAINER TECHNICAL ASSISTANCE TRACKING FORM No Health Health Care Services
None Master Trainer TA Tracking Form No No Paper Only Form Atmt_DDDD_Student_Program_Master_Trainer_TA_Track__Form-FINAL[1].docx
Individuals or Households 600 100 0

Educator Outcome Evaluation Survey-Follow-up No Health Health Care Services
none Educator Outcome Survey Follow-up No No Paper Only Form and instruction Atmt IIII - Educator_ Outcome_Survey_Follow-Up.docx
Individuals or Households 1584 792 0

Community Capacity/Readiness Assessment No Health Health Care Services
none Community Capacity/Readiness Assessment Yes No Paper Only Form and instruction Atmt JJJJ - Community_Capacity_and_Readiness_Assessment.docx
Individuals or Households 80 80 0

Communications Focus Groups No Health Health Care Services Individuals or Households 96 144 0

Parent Program Manager TA Tracking Form No Health Health Care Services
none Parent Program Manager (PPM) Technical Assistance Tracking form Yes No Paper Only Form Atmt LLLL - Parent_Program_Manager_TA_Tracking_ Form.docx
Individuals or Households 200 33 0

6th Grade Curricula Parent Satisfaction Questionnaire No Health Health Care Services
none Parents Matter! for Dating Matters: Participant Satisfaction Questionnaire Yes No Paper Only Form and instruction Atmt MMMM - 6th_Grade_Curricula_Participant_Satisfaction_Questionnaire.docx
Individuals or Households 1890 315 0

7th Grade Curricula Parent Satisfaction Questionnaire No Health Health Care Services
Yes No Paper Only Instruction Atmt OOOO - Student_Assent_For_Communications_Focus_Group_Participation.doc none Dating Matters for Parents: Participant Satisfaction Questionnaire Yes No Paper Only Form and instruction Atmt NNNN - 7th_Grade_Curricula_Parent_Participant_Satisfaction_Questionnaire.docx
Individuals or Households 1890 315 0

2013-09-12-04:00

0920-0942 201202-0920-004 0920
             
        "HIV Prevention among Latino MSM:  Evaluation of a locally developed intervention"
             
          
        
This study will use a randomized controlled trial design to collect data needed to assess the efficacy of the Spanish-language, small-group HOLA en Grupos intervention compared to a general health comparison intervention. 2015-06-30-04:00 Active Catina Conner 4046394775 No No No 950 883 0

Participant Screening Form No Health Public Health Monitoring Individuals or Households 350 58 0

Baseline Assessment Questionnaire No Health Public Health Monitoring Individuals or Households 300 525 0

6-Month Follow-up Assessment No Health Public Health Monitoring Individuals or Households 300 300 0

2012-06-28-04:00

0920-0943 201206-0920-004 0920
             
        "Data Collection for the Residential Care Community and Adult Day Services Center Components of the National Study of Long-term Care Providers"
             
          
        
NCHS seeks approval to collect data for the residential care community (RCC) and adult day services center (ADSC) components of a new study, the National Study of Long-Term Care Providers (NSLTCP). Data from RCCs and ADSCs include basic characteristics, services offered, staffing, and practices of providers, and distributions of the demographics, physical functioning, and cognitive functioning of users (RCC residents and ADSC participants) aggregated to the RCC/ADSC level. The study will be administered by mail, web, and telephone to a sample of 11,701 RCCs and a census of 5,000 ADSCs in the 50 states and the District of Columbia. 2015-07-31-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 18371 8769 0

Residential Care Community Questionnaire No Health Consumer Health and Safety
none RCC Questionnaire Items Yes Yes Fillable Printable Form Attachment B RCC questionnaire items 7-25.docx
Private Sector 11701 5851 0

Adult Day Services Center Questionnaire No Health Consumer Health and Safety
none ADSC Questionnaire Items Yes Yes Fillable Printable Form Attachment C ADSC questionnaire items 7-25.docx
Private Sector 5000 2500 0

Data Retrieval Telephone Call Questionnaire No Health Consumer Health and Safety
none Data Retrieval Telephone Call No No Paper Only Form Attachment I Data Retrieval Call 5-8.docx
Private Sector 1670 418 0

2012-07-30-04:00

0920-0945 201205-0920-010 0920
             
        "Critical Thinking and Cultural Affirmation: Evaluation of a Locally Developed HIV Prevention Intervention"
             
          
        
The study will test the efficacy of the Critical Thinking and Cultural Affirmation (CTCA) HIV risk behavior intervention in reducing HIV risk behaviors among a sample of AAMSM in Chicago. It aims to further explicate and develop the CTCA intervention, to evaluate efficacy and cost-effectiveness in reducing AAMSM HIV risk behaviors, and to expand the body of research on HIV prevention/risk reduction practices for AAMSM. The study uses a randomized-controlled trial design to compare receiving the intervention to receiving basic men's health and wellness messaging. 2015-08-31-04:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 2221 588 0

Pre-screening No Health Consumer Health and Safety
none Pre-screening No No Paper Only Form Attachment 3 Pre-screening Form.docx
Individuals or Households 333 28 0

Full-screening No Health Consumer Health and Safety
none Full-screening No No Paper Only Form Attachment 4 Full-screening Form.docx
Individuals or Households 172 29 0

Brief Locator Information No Health Consumer Health and Safety
none Brief Locator Information No No Paper Only Form Attachment 5 Brief Locator Form.docx
Individuals or Households 172 14 0

Baseline Assessment No Health Consumer Health and Safety
Attachment 6 Baseline Assessment Yes Yes Fillable Fileable Form Baseline Assessment_OMB Comments.7.4.12 revised_clean.docx
Individuals or Households 146 146 0

Record Locator Form No Health Consumer Health and Safety
none Record Locator Form No No Paper Only Form Attachment 7 Record Locator Form.docx
Individuals or Households 146 24 0

Participant Evaluation No Health Consumer Health and Safety
none Participant Evaluation No No Paper Only Form Attachment 8 Participant Evaluation Forms.docx
Individuals or Households 876 73 0

3-month Assessment No Health Consumer Health and Safety
Attachment 9 3 month follow-up Yes Yes Fillable Fileable Form 3-mo Assessment_OMB Comments.7.4.12 revised_clean.docx
Individuals or Households 132 132 0

6-month Assessment No Health Consumer Health and Safety
Attachment 10 6-Month Assessment Yes Yes Fillable Fileable Form 6-mo Assessment_OMB Comments.7.4.12 revised_clean.docx
Individuals or Households 117 117 0

Exit Survey No Health Consumer Health and Safety
none Exit Survey Yes Yes Fillable Fileable Form Attachment 11 Exit Survey.docx
Individuals or Households 117 20 0

Exit Interview No Health Consumer Health and Safety
none Exit Interview No No Paper Only Form Attachment 12 Exit Interview.docx
Individuals or Households 10 5 0

2012-08-01-04:00

0920-0946 201211-0920-002 0920
             
        "Monitoring And Reporting System For Community Transformation Grant Awardees"
             
          
        
CDC Plans to collection information from awardees funder under the community transformation grant (CTG) program. Awardees will report progress and activity information to CDC unsing an electronic Management information system(MIS). Reports are due twice per year but updates can be enetered at any time. OMB approval is requested for three years. 2015-08-31-04:00 Active Catina Conner 4046394775 No Yes No 230 858 0

State/Local/Tribal Government Sector CTG Awardees - Semiannual Reporting No Health Public Health Monitoring State, Local, and Tribal Governments 130 390 0

Private Sector CTG Awardees - Semiannual Reporting No Health Public Health Monitoring Private Sector 86 258 0

State/Local/Tribal Government Sector CTG Awardees - Initial Population of the CTG MIS No Health Public Health Monitoring State, Local, and Tribal Governments 4 60 0

Private Sector CTG Awardees - Initial Population of the CTG MIS No Health Public Health Monitoring Private Sector 10 150 0

2012-11-01-04:00

0920-0947 201206-0920-007 0920
             
        "Communications Research for the Development of Messages and Materials about Cytomegalovirus (CMV)"
             
          
        
NCBDDD will conduct a multiphase communication research study to determine effective CMV communication strategies to reach the target audiences. The first phase will be largely exploratory and will include focus groups with Caucasian and African-American pregnant or expecting mothers ages 18-40 who also have a child age 5 years or younger. The focus groups will assess understanding of audience members' knowledge, attitudes, and beliefs about CMV, their perceptions about personal risk and prevention behaviors, their communication preferences, and initial reactions to CDC CMV messages and materials. The second phase will consist of a web survey to assess baseline awareness and knowledge regarding congenital CMV, measure current CMV prevention behaviors prior to viewing any CMV communication interventions (factsheet, video) and CDC's CMV prevention guidelines, and test refined CDC CMV messages and materials with a larger sample of the target audience. 2014-09-30-04:00 Active Petunia Gissendaner 4046390164 No No No 5960 543 0

CMV Focus Group Screener No Health Health Care Services
none CMV Focus Group Screener No No Paper Only Form Attachment 3A CMV Focus Group Screener.docx
Individuals or Households 144 12 0

Focus Group Discussion Guide No Health Health Care Services Individuals or Households 72 108 0

Focus Group Demographic Profile Questionnaire and Focus Group Informed Consent No Health Health Care Services
none Focus Group Demographic Profile Questionnaire No No Paper Only Form Attachment 3C Focus Group Demographic Profile Questionnaire.docx
Individuals or Households 72 18 0

Web Survey Screener and Web Survey Screener Screenshots No Health Health Care Services
none Web Survey No Paper Only Form and instruction Attachment 3E Web Survey Screener Screenshots Rev 9 5.docx
Individuals or Households 4800 240 0

Web Survey: Fact Sheet, Factsheet Testing Screenshots, Video Testing, and Testing Screenshots No Health Health Care Services
none Web Survey Factsheet No Paper Only Form and instruction Attachment 3G Web Survey Factsheet Testing Screenshots Rev 9 5.docx none Web Survey No Paper Only Form and instruction Attachment 3E Web Survey Screener Screenshots Rev 9 5.docx none Web Survey Video No Paper Only Form and instruction Attachment 3I Web Survey Video Testing Screenshots Rev 9 5.docx
Individuals or Households 800 147 0

Informed Consent form No Health Health Care Services
none Informed Consent No Paper Only Form and instruction Attachment 4_Focus Group Informed Consent (rev08272012).docx
Individuals or Households 72 18 0

2012-09-10-04:00

0920-0949 201206-0920-005 0920
             
        "Evaluating the Effectiveness of  Occupational Safety and Health Program Elements in theWholesale Retail Sector "
             
          
        
NIOSH proposes to conduct a study to assess the effectiveness of occupational safety and health (OSH) elements (MSDs) among wholesale/ retail trade (WRT) employers The proposed research involves a firm-level survey of a series of organizational metrics considered to be potential predictors of injury and illness WC claim rates and duration in a stratified sample of Ohio Bureau of Workers Compensation (OBWC)-insured WRT firms in Ohio. There are expected to be up to 4,104 participant firms and surveys will be administered twice to the same firms in successive years (e.g. from January- December 2013 and again from January- December 2014). A nested study at 60 firms will ask multiple respondents at each firm to participate. 2015-10-31-04:00 Active Petunia Gissendaner 4046390164 No No No 9600 1681 0

Occupational Safety and Health Program Evaluation Survey Year1 No Workforce Management Training and Employment
None Occupational Safety and Health Program Evaluation Survey Year 1 Yes Yes Fillable Fileable Form and instruction Attachment H-1Year 1 Survey 5_08_12.docx None Occupational Safety and Health Program Evaluation Survey Year 2 Yes Yes Fillable Fileable Form and instruction Attachment H-2 Year 2 Survey 5_08_12.docx
Private Sector 4404 1468 0

INFORMED CONSENT TO PARTICIPATE IN A LEADING INDICATORS BENCHMARKING RESEARCH PROJECT No Workforce Management Training and Employment
None INFORMED CONSENT TO PARTICIPATE IN A LEADING INDICATORS BENCHMARKING RESEARCH PROJECT Yes Yes Fillable Fileable Form and instruction Attachment G Informed Consent 5_08_12.docx
Private Sector 4404 147 0

Non-Respondent Follow-up Interview No Workforce Management Training and Employment
None Non-Respondent Follow-up Interview Yes Yes Fillable Fileable Form and instruction Attachment L NonResp Followup 5_08_12.docx
Private Sector 792 66 0

2012-10-22-04:00

0920-0950 201311-0920-004 0920
             
        "National Health and Nutrition Examination Survey"
             
          
        
The National Health and Nutrition Examination Survey (NHANES) is a continuous nationally representative sample of the civilian, non-institutionalized U.S. population. The survey is unique in that it contains interview, laboratory and physical examination segments. The examination component is conducted in mobile examination centers that travel to fifteen survey locations each year. NHANES data have been the cornerstone for numerous national health and nutrition policy and surveillance activities. This request seeks a revised approval for data collection for the 2013-2014 survey to include the 24-Hour Urine Collection Project. 2015-11-30-05:00 Active Thelma Sims 4046394771 No No No 17911 46028 0

NHANES Questionnaire No Health Immunization Management
none NHANES Questionnaire Yes Yes Fillable Fileable Form and instruction Attachment 9 Questionnaire & MEC Forms 2013-14 rev 10-4-12.docx
Individuals or Households 15411 38528 0

Special Studies and Pretests No Health Immunization Management Individuals or Households 2500 7500 0

National Health and Nutrition Examination Survey (NHANES) 24-Hour Urine Pilot Study No Health Immunization Management Individuals or Households 0 0 0

2013-12-09-05:00

0920-0952 201311-0920-011 0920
             
        "Process Evaluation of "Teenage Pregnancy Prevention:  Integrating Services, Programs, and Strategies through Community-Wide Initiatives""
             
          
        
To improve usability, data quality, and respondent satisfaction in completing the assessment, CDC desires to make changes to the State and Community Awardee Performance Measure Reporting Tool. 2015-12-31-05:00 Active Carol Marsh cww6@cdc.gov 404 639-4773 No No No 1039 1150 0

Community and Clinical Partner Clinical Partner Needs Assessment No Health Health Care Services
0920-0952 Attachment 4 (electronic) Yes Yes Fillable Printable Form and instruction Attachment 4 (electronic).pdf N/A Att 4 Clincal Partner Needs Assessment.Revised No No Paper Only Form and instruction Att 4 Clincal Partner Needs Assessment.Revised.docx
Private Sector 50 50 0

Community and Clinical Partner Program Implementation Partner Needs Assessment No Health Health Care Services
0920-0952 Attachment 5 (electronic) Yes Yes Fillable Fileable Form and instruction Attachment 5 (electronic).pdf N/A Att 5 Com and Clinical Partners Prog Implem Partner Needs Assmt.Revised No No Paper Only Form and instruction Att 5 Com and Clinical Partners Prog Implem Partner Needs Assmt.Revised.docx
Private Sector 100 75 0

State and Community Awardee Performance Measure Reporting Tool No Health Health Care Services
none State and Community Awardee Tool Yes Yes Fillable Fileable Form Att 6 (rev) State and Community Awardee Performance Measure Reporting Tool.docx
Private Sector 50 200 0

State and Community Awardee Project Director/Project Coordinator Needs Assessment No Health Health Care Services
none New Web Survey Yes Yes Fillable Fileable Form Attachment 7 (web) State and Community Awardee Project Coordinator Project Director Needs Assessment.pdf
Private Sector 9 7 0

State and Community Awardee Staff Needs Assessment No Health Health Care Services
none new Web-based Survey Yes Yes Fillable Fileable Form Attachment 8 (web) State and Community Awardee Staff Needs Assessment.pdf
Private Sector 50 38 0

State and Community Awardee Training and Technical Assistance Reporting Form No Health Health Care Services
no State and Community Awardee Training and Technical Assistance Reporting Form Yes Yes Fillable Fileable Form Attachment 9. State and Community Awardee Training and Technical Assistance Tool.docx
Private Sector 600 600 0

National Organization Training and Technical Assistance Reporting Form No Health Health Care Services
no National Organization Training and Technical Assistance Reporting Form Yes Yes Fillable Fileable Form Attachment 10. National Organization Awardee Training and Technical Assistance Tool.docx
Private Sector 180 180 0

2013-11-20-05:00

0920-0953 201211-0920-003 0920
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIOSH 2)"
             
          
        
This collection of information is necessary to enable the Agency to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the agency's programs. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. 2015-12-31-05:00 Active Carol Walker 4046394773 No No No 334500 86250 0

Manual of Analytical Methods Customer Satisfaction Survey No Health Immunization Management
none Manual of Analytical Methods Survey Yes Yes Fillable Fileable Form NMAM survey 01182013.pdf
Private Sector 500 250 0

World Trade Center (WTC) Health Program General Responder Consortium (GRC) Outreach Survey No Health Health Care Services
None World Trade Center Health Program Member Questionnaire Yes No Fillable Printable Form and instruction WTCHP Questionnaire.docx Yes No Paper Only Instruction WTCHP- Telephone Script.docx
Individuals or Households 1319 165 0

World Trade Center (WTC) Health Program General Responder Consortium (GRC) Outreach Survey (Spanish and Polish versions) No Health Health Care Services
None Members in the WTCHP General Responders Consortium Polish Version Yes No Paper Only Form and instruction WTCHP GRC Outreach Survey Polish.docx None Members in the WTCHP General Responders Consortium--Spanish Version Yes No Paper Only Form and instruction WTCHP GRC Outreach Survey Spanish.docx
Individuals or Households 1 0 0

The World Trade Center Health Program for Responders at Rutgers University Customer Satisfaction Survey No Health Health Care Services
0920-0953 Patient Satisfaction Survey-Rutgers 12.10.13 Yes Yes Fillable Fileable Form and instruction Patient Satisfaction Survey-Rutgers 12.10.13.doc
Individuals or Households 600 50 0

North Shore LIJ Customer Satisfaction Survey No Health Health Care Services
None Medical Practice Survey Yes No Paper Only Form and instruction Patient Satisfaction Survey-Queens.pdf
Individuals or Households 2000 240 0

Long Island WTC Health Program Survey No Health Health Care Services
none Long Island Patient Satisfaction Survey No No Paper Only Form Long Island Survey.doc
Individuals or Households 4200 280 0

The Nationwide Provider Network Customer Satisfaction Survey No Health Health Care Services Individuals or Households 6300 420 0

Logistics Health Incorporated (LHI) No Health Health Care Services Individuals or Households 6300 420 0

2012-12-21-05:00

0920-0954 201209-0920-008 0920
             
        "Fetal Alcohol Spectrum Disorders Regional Training Centers "
             
          
        
NCBDDD will collect program evaluation data from participants of trainings for medical and allied health students and practitioners regarding fetal alcohol spectrum disorders (FASDs) conducted by the FASD Regional Training Centers through a cooperative agreement with CDC. Guidelines for the diagnosis of FAS and other negative birth outcomes resulting from prenatal exposure to alcohol have been developed and incorporated into the training curricula, to help students and professionals with the prevention, identification, and treatment of FAS and related disorders. 2015-02-28-05:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 15640 2654 0

Arctic Foundations Pre-test No Health Consumer Health and Safety
none Foundations Pre-test No No Paper Only Form Att C1 Arctic RTC - Foundations Pre.docx
Individuals or Households 30 8 0

Arctic Foundations Post-test No Health Consumer Health and Safety
none Foundations Post-test No No Paper Only Form Att C2 Arctic RTC - Foundations Post.docx
Individuals or Households 30 8 0

Arctic Foundations Follow-up No Health Consumer Health and Safety
none Found ations Follow-up Yes Yes Fillable Fileable Form Att C3 Arctic RTC - Foundations FollowUp.docx
Individuals or Households 18 3 0

Arctic FASD 201 Pre-test No Health Consumer Health and Safety
none FASD 201 Pre-test No No Paper Only Form Att C4 Arctic RTC - FASD 201 Pre.docx
Individuals or Households 30 5 0

Arctic FASD 201 Post-test No Health Consumer Health and Safety
none FASD 201 Post-test No No Paper Only Form Att C5 Arctic RTC - FASD 201 Post.docx
Individuals or Households 30 5 0

Arctic FASD 201 Follow-up No Health Consumer Health and Safety
none FASD 201 Follow-up Yes Yes Fillable Fileable Form Att C6 Arctic RTC - FASD 201 Follow-Up.docx
Individuals or Households 18 3 0

Arctic Intro to FASD Pre-test No Health Consumer Health and Safety
none Intro to FASD Pre-test No No Paper Only Form Att C7 Arctic RTC - Intro to FASDs Pre.docx
Individuals or Households 80 20 0

Arctic Intro to FASD Post-test No Health Consumer Health and Safety
none Intro to FASD Post-test No No Paper Only Form Att C8 Arctic RTC - Intro to FASDs Post.docx
Individuals or Households 80 20 0

Arctic Intro to FASD Follow-up No Health Consumer Health and Safety
none Intro to FASD Follow-up Yes Yes Fillable Fileable Form Att C9 Arctic RTC - Intro to FASDs FollowUp.docx
Individuals or Households 48 8 0

Arctic Train the Trainer Pre-test No Health Consumer Health and Safety
none Train the Trainer Pre-test No No Paper Only Form Att C10 Arctic RTC - Train-the-Trainer Pre.docx
Individuals or Households 25 6 0

Arctic Train the Trainer Post-test No Health Consumer Health and Safety
none Train the Trainer Post-test No No Paper Only Form Att C11 Arctic RTC - Train-the-Trainer Post.docx
Individuals or Households 25 6 0

Arctic Train the Trainer Follow-up No Health Consumer Health and Safety
none Train the Trainer Follow-up Yes Yes Fillable Fileable Form Att C12 Arctic RTC - Train-the-Trainer Follow-Up.docx
Individuals or Households 15 4 0

Arctic Online I Pre- and Post-test No Health Consumer Health and Safety
none Online I Pre- and Post-test Yes Yes Fillable Fileable Form Att C13 Arctic RTC - Online Course I Pre_Post.docx
Individuals or Households 200 33 0

Arctic Online II Pre- and Post-test No Health Consumer Health and Safety
none Online II Pre- and Post-test Yes Yes Fillable Fileable Form Att C14 Arctic RTC - Online Course II Pre_Post.docx
Individuals or Households 200 33 0

Arctic Online III Pre- and Post-test No Health Consumer Health and Safety
none Online III Pre- and Post-test Yes Yes Fillable Fileable Form Att C15 Arctic RTC - Online Course III Pre_Post.docx
Individuals or Households 200 33 0

Arctic Classroom and Special Event Post-test No Health Consumer Health and Safety
none Classroom and Special Event Post-test No No Paper Only Form Att C16 Arctic RTC - Classroom_SpecEvent_ Post (0905).docx
Individuals or Households 300 30 0

Frontier Nursing Pre-test No Health Consumer Health and Safety
none Nursing Pre-test No No Paper Only Form D1 Frontier Regional FASD Training Center Nursing Pre-test.doc
Individuals or Households 410 103 0

Frontier Nursing Post-test No Health Consumer Health and Safety
none Nursing Post-test No No Paper Only Form D2 Frontier Regional FASD Training Center Nursing Post-test.doc
Individuals or Households 410 103 0

Frontier Nursing Follow-up No Health Consumer Health and Safety
none Nursing Follow-up Yes Yes Fillable Fileable Form D3 Frontier Regional FASD Training Center Nursing Follow-up.doc
Individuals or Households 410 103 0

Frontier Social Work Pre-test No Health Consumer Health and Safety
none Social Work Pre-test No No Paper Only Form D4 Frontier Regional FASD Training Center Social Work Pre-test.doc
Individuals or Households 410 103 0

Frontier Social Work Post-test No Health Consumer Health and Safety
none Social Work Post-test No No Paper Only Form D5 Frontier Regional FASD Training Center Social Work Post-test.doc
Individuals or Households 410 103 0

Frontier Social Work Follow-up No Health Consumer Health and Safety
none Social Work Follow-up Yes Yes Fillable Fileable Form D6 Frontier Regional FASD Training Center Social Work Follow-up.doc
Individuals or Households 410 103 0

Frontier Allied Health Practioner Pre-test No Health Consumer Health and Safety
none Allied Health Pre-test No No Paper Only Form D7 Frontier Regional FASD Training Center Practitioner Pre-test.doc
Individuals or Households 200 50 0

Frontier Allied Health Practioner Post-test No Health Consumer Health and Safety
none Allied Health Post-test No No Paper Only Form D8 Frontier Regional FASD Training Center Practitioner Post-test.doc
Individuals or Households 200 50 0

Frontier Allied Health Practioner Follow-up No Health Consumer Health and Safety
none Allied Health Follow-up Yes Yes Fillable Fileable Form D9 Frontier Regional FASD Training Center Practitioner Follow-up.doc
Individuals or Households 200 50 0

Frontier Training of Trainers Pre-test No Health Consumer Health and Safety
none Training of Trainers Pre-test No No Paper Only Form D10 Frontier Regional FASD Training Center Training of Trainers Pre-test.doc
Individuals or Households 100 25 0

Frontier Training of Trainers Post-test No Health Consumer Health and Safety
none Training of Trainers Post-test No No Paper Only Form D11 Frontier Regional FASD Training Center Training of Trainers Post-test.doc
Individuals or Households 100 25 0

Frontier Training of Trainers Follow-up No Health Consumer Health and Safety
none Training of Trainers Follow-up Yes Yes Fillable Fileable Form D12 Frontier Regional FASD Training Center Training of Trainers Follow-up.doc
Individuals or Households 100 25 0

Frontier Academic Faculty and Students Online Pre-test No Health Consumer Health and Safety
none Academic Pre-test Yes Yes Fillable Fileable Form D13 Frontier Regional FASD Training Center Online Academic Course Pre-test_(Rev0905).pdf
Individuals or Households 150 38 0

Frontier Academic Faculty and Students Online Post-test No Health Consumer Health and Safety
none Academic Post-test Yes Yes Fillable Fileable Form D14 Frontier Regional FASD Training Center Online Academic Post-test_(Rev0905).pdf
Individuals or Households 150 38 0

Frontier Academic Faculty and Students Online Follow-up No Health Consumer Health and Safety
none Academic Follow-up Yes Yes Fillable Fileable Form D15 Frontier Regional FASD Training Center Online Academic Follow-up_(Rev0905).pdf
Individuals or Households 150 38 0

Frontier Practitioner Online Pre-test No Health Consumer Health and Safety
none Practitioner Online Pre-test Yes Yes Fillable Fileable Form D16 Frontier Regional FASD Training Center Online Practioner Pre-test_(Rev0905).pdf
Individuals or Households 160 40 0

Frontier Practitioner Online Post-test No Health Consumer Health and Safety
none Practitioner Online Post-test Yes Yes Fillable Fileable Form D17 Frontier Regional FASD Training Center Online Practioner Post-test_(Rev0905).pdf
Individuals or Households 160 40 0

Frontier Practitioner Online Follow-up No Health Consumer Health and Safety
none Practitioner Online Follow-up Yes Yes Fillable Fileable Form D18 Frontier Regional FASD Training Center Online Practioner Follow-up_(Rev0905).pdf
Individuals or Households 160 40 0

Great Lakes Medical and Allied Health Care Providers Pre-test No Health Consumer Health and Safety
none Foundations Online Pre-test Yes Yes Fillable Fileable Form E1a_screenshots Great Lakes FASD RTC QUALTRICS Foundatio_pre.pdf
Individuals or Households 450 38 0

Great Lakes Medical and Allied Health Care Providers Post-test No Health Consumer Health and Safety
none Foundations Online Post-test Yes Yes Fillable Fileable Form E2a_screenshots Great Lakes FASD RTC QUALTRICS Foundatio_post.pdf
Individuals or Households 450 75 0

Great Lakes Medical and Allied Health Care Providers Follow-up No Health Consumer Health and Safety
none Foundations Online Follow-up Yes Yes Fillable Fileable Form E3a_screenshots Great Lakes FASD RTC QUALTRICS Foundatio 6mo.pdf
Individuals or Households 310 26 0

Great Lakes Health Care Providers SBI Pre-test No Health Consumer Health and Safety
none SBI Pre-test Yes Yes Fillable Fileable Form E4a_screenshots Great Lakes FASD RTC QUALTRICS Screenin.pdf
Individuals or Households 120 16 0

Great Lakes Health Care Providers SBI Post-test No Health Consumer Health and Safety
none SBI Post-test Yes Yes Fillable Fileable Form E5a_screenshots Great Lakes FASD RTC QUALTRICS Screenin_post.pdf
Individuals or Households 120 26 0

Great Lakes Health Care Providers SBI Follow-up No Health Consumer Health and Safety
none SBI Follow-up Yes Yes Fillable Fileable Form E6a_screenshots Great Lakes FASD RTCQUALTRICS Screening and Brief Intervent.pdf
Individuals or Households 108 14 0

Great Lakes Healthcare Providers ID and Treatment Pre-test No Health Consumer Health and Safety
none ID and Treatment Pre-test Yes Yes Fillable Fileable Form E7a_screenshots Great Lakes FASD RTCQUALTRICS Identification and Treatment.pdf
Individuals or Households 270 36 0

Great Lakes Healthcare Providers ID and Treatment Post-test No Health Consumer Health and Safety
none Great Lakes ID and Treatment Post-test Yes Yes Fillable Fileable Form E8a_screenshots Great Lakes FASD RTCQUALTRICS Identification and Treatment _1.pdf
Individuals or Households 270 59 0

Great Lakes Healthcare Providers ID and Treatment Follow-up No Health Consumer Health and Safety
none Great Lakes ID and Treatment Follow-up Yes Yes Fillable Fileable Form E9a_screenshots Great Lakes FASD RTCQUALTRICS Identification and Treatment.pdf
Individuals or Households 258 34 0

Great Lakes Healthcare Providers Comprehensive Pre-test No Health Consumer Health and Safety
none Great Lakes Comprehensive Pre-test Yes Yes Fillable Fileable Form E10a_screenshots Great Lakes FASD RegionalTraining Center QUALTRICS FASD Com.pdf
Individuals or Households 220 55 0

Great Lakes Healthcare Providers Comprehensive Post-test No Health Consumer Health and Safety
none Great Lakes Comprehensive Post-test Yes Yes Fillable Fileable Form E11a_screenshots Great Lakes FASD RegionalTraining Center QUALTRICS FASD Com.pdf
Individuals or Households 220 73 0

Great Lakes Healthcare Providers Comprehensive Follow-up No Health Consumer Health and Safety
none Great Lakes Comprehensive Follow-up Yes Yes Fillable Fileable Form E12a_screenshots Great Lakes FASD RegionalTraining Center QUALTRICS FASD Com.pdf
Individuals or Households 204 51 0

Great Lakes Physicians Clinical Experience A No Health Consumer Health and Safety
none Great Lakes Physicians Clinical Experience A No No Paper Only Form E13_Great Lakes FASD RegionalTraining Center Clinical Experienc.docx
Individuals or Households 25 2 0

Great Lakes Physicians Clinical Experience B No Health Consumer Health and Safety
none Great Lakes Physicians Clinical Experience B No No Paper Only Form E14_Great Lakes FASD RegionalTraining Center Clinical Experienc.docx
Individuals or Households 25 2 0

Great Lakes Trainers Key Informant Interview No Health Consumer Health and Safety
none Great Lakes Trainers Key Informant Interview No No Paper Only Form E15_Great Lakes FASD RegionalTraining Center Key Informant Inte.pdf
Individuals or Households 16 4 0

Great Lakes Regional State Partners Key Informant Interview No Health Consumer Health and Safety
none Great Lakes Regional State Partners Key Informant Interview No No Paper Only Form E16_Great Lakes FASD RegionalTraining Center Key Informant Inte.pdf
Individuals or Households 15 5 0

Great Lakes Advisory Committee Key Informant Interview No Health Consumer Health and Safety
none Great Lakes Advisory Committee Key Informant Interview No No Paper Only Form E17_Great Lakes FASD RegionalTraining Center Key Informant Inte.pdf
Individuals or Households 10 3 0

Great Lakes Trainers Harvard Minute Feedback No Health Consumer Health and Safety
none Great Lakes Trainers Harvard Minute Feedback No No Paper Only Form E18_Great Lakes FASD RegionalTraining Center Harvard Minute Free.pdf
Individuals or Households 100 2 0

Great Lakes Trainers Activity Reporting No Health Consumer Health and Safety
none Great Lakes Trainers Activity Reporting No No Paper Only Form E19_Great Lakes FASD RegionalTraining Center Training Activity.pdf
Individuals or Households 180 6 0

Midwest Academic Knowledge Pre-test No Health Consumer Health and Safety
none Midwest Academic Knowledge Pre-test No No Paper Only Form F1_Midwest FASD Regional Training Center Knowledge Pre-Test.doc
Individuals or Households 1080 126 0

Midwest Academic Knowledge Post-test and Follow-up No Health Consumer Health and Safety
none Midwest Academic Knowledge Post-test and Follow-up Yes Yes Fillable Fileable Form F2a_ screenshots Midwest FASD Regional Training Center Knowledge Assessment 3 mo FU_online (0905).pdf
Individuals or Households 2160 252 0

Midwest Event Evaluation No Health Consumer Health and Safety
none Midwest Event Evaluation No No Paper Only Form F3_Midwest FASD Regional Training Center Event Evaluation.doc
Individuals or Households 1110 93 0

Midwest Continuing Education Pre-test No Health Consumer Health and Safety
none Midwest Continuing Education Pre-test No No Paper Only Form F4_Midwest FASD Regional Training Center Continuing Education Event, Practice Behaviors Self-Efficacy, Pre-Test.doc
Individuals or Households 250 21 0

Midwest Continuing Education Post-test No Health Consumer Health and Safety
none Midwest Continuing Education Post-test No No Paper Only Form F5_Midwest FASD Regional Training Center Continuing Education Event, Practice Behaviors Self-Efficacy, Post-Test.doc
Individuals or Households 250 21 0

Midwest Continuing Education Follow-up No Health Consumer Health and Safety
none Midwest Continuing Education Follow-up Yes Yes Fillable Fileable Form F6_Midwest FASD RTC Continuing Education Event, Practice Beh Self-Eff, 3 mo Follow-up - online survey.pdf
Individuals or Households 250 21 0

Midwest Modified Index Collaboration Pre-test and Follow-up No Health Consumer Health and Safety
none Midwest Modified Index Collaboration Pre-test and Follow-up Yes Yes Fillable Fileable Form F7a_screenshots Midwest FASD RTC Modified Index of Interdisciplinary Collab, 3 mo Follow-up - online survey.pdf
Individuals or Households 150 25 0

Midwest Utilization of Curriculum Pre-test and Follow-up No Health Consumer Health and Safety
none Midwest Utilization of Curriculum Pre-test and Follow-up Yes Yes Fillable Fileable Form F8a_screenshots Midwest FASD RTC Utilization of FAS-FASD Curr 3 mo Follow-up - online survey.pdf
Individuals or Households 100 8 0

Southeast Pre-test No Health Consumer Health and Safety
none Southeast Pre-test No No Paper Only Form G1_FASD Southeast Regional Training Center Pre-Test Evaluation Questions.doc
Individuals or Households 500 83 0

Southeast Post-test No Health Consumer Health and Safety
none Southeast Post-test No No Paper Only Form G2_FASD Southeast Regional Training Center Post-Test Evaluation Questions and Program Evaluation.doc
Individuals or Households 500 125 0

Southeast Follow-up No Health Consumer Health and Safety
none Southeast Follow-up Yes Yes Fillable Fileable Form G3_FASD Southeast Regional Training Center 3 Month Follow-up Evaluation Questions.doc
Individuals or Households 300 50 0

2013-02-04-05:00

0920-0955 201301-0920-005 0920
             
        "Early Hearing Detection and Intervention - Pediatric Audiology Links to Service (EHDI-PALS) Facility Survey"
             
          
        
NCBDDD will collect data from pediatric audiologists who provide services to children age 5 and younger. The overall purpose of this study is to identify and quantify the audiology facility resources in the U.S. Facility data will be compiled into a distribution map for CDC-EHDI team and state EHDI coordinators to visualize the geographic distribution of infants who are lost to follow up in relationship to the pediatric audiology clinic distribution. Since April 2010, the EHDI-PALS workgroup has sought consensus on the loss to follow up/loss to documentation issues facing EHDI programs. 2014-02-28-05:00 Active Thelma Sims 4046394771 No No No 3500 258 0

EHDI-PALS Facility Survey Opening No Health Health Care Services Individuals or Households 2000 33 0

EHPI-PALS Facility Survey No Health Health Care Services Individuals or Households 1500 225 0

2013-02-18-05:00

0920-0956 201303-0920-011 0920
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery"
             
          
        
This collection of information is necessary to enable the Agency to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the Agency's programs. 2016-03-31-04:00 Active Thelma Sims 4046394771 No No No 10250 5250 0

Vital Signs Survey No Health Health Care Services
None Vital Signs Survey Yes Yes Fillable Fileable Form and instruction VS_screenshots.docx None Vital Signs Survey Yes Yes Printable Only Form and instruction Vital Signs Surveyv2.docx
Individuals or Households 3000 351 0

Solve the Outbreak iPad Survey No Health Health Care Services
none Survey Yes Yes Fillable Fileable Form STO_screenshots.docx
Individuals or Households 5000 417 0

CDC Homepage Mobile & Desktop Survey No Health Immunization Management
None CDC Homepage Mobile and Desktop Yes Yes Fillable Fileable Form Surveys for cdc homepage mobile desktop.docx None CDC Homepage Mobile & Desktop Survey Yes Yes Fillable Fileable Form Survey Images for cdc homepage mobile desktop.docx
Individuals or Households 600 70 0

Testing of Sample Materials Developed Using the CDC Clear Communications Index No Health Consumer Health and Safety
None Attachment 9: CDC Priorities and FY 2014 Budget Request Yes Yes Fillable Printable Form and instruction Attachment9_Policymakers_CDC-Budget-Overview_2013.10.31.docx None Attachment 10: CDC Keeps America Healthy, Safe, and Secure. Case Study: Fort Leonard Wood, Missouri Yes Yes Fillable Printable Form and instruction Attachment10_Policymakers_Introduction-to-Epidemiology_2013.10.31.docx None Attachment 8: The National Violent Death Reporting System (NVDRS): A Valuable Tool for Prevention Yes Yes Fillable Printable Form and instruction Attachment8_Public-Health-Department-Staff_National-Violent-Death-Reporting-System_2013.10.31.docx None Attachment 7: Use the Model Aquatic Health Code to Make Swimming Healthy and Safe Yes Yes Fillable Printable Form and instruction Attachment7_Public-Health-Department-Staff_Model-Aquatic-Health-Code_2013.10.31.docx None Attachment 6: Heart Disease Facts Yes Yes Fillable Printable Form and instruction Attachment6_CDC-Partners_Heart-Disease-Fact-Sheet_2103.10.31.docx None Attachment 5: HAI Summary Data Reports: Questions and Answers Yes Yes Fillable Printable Form and instruction Attachment5_CDC-Partners_Healthcare-Associated-Infections_2013.10.31.docx None Attachment 3: Flu Vaccine Information for Health Care Workers Yes Yes Fillable Printable Form and instruction Attachment3_Clinicians_Influenza_2013.10.31.docx None Attachment 4: Autism and Developmental Disabilities Monitoring Network (ADDM) Tracking Autism in Wisconsin: What You Need to Know Yes Yes Fillable Printable Form and instruction Attachment4_Clinicians_Wisconsin-Surveillance-of-Autism_2013.10.31.docx None Attachment 2: Click Testing Screen Shots Yes Yes Printable Only Form and instruction Attachment-2-verify-screenshots_2013.11.19_LOW.pdf
Federal Government 32 11 0

CDC Homepage UX No Health Immunization Management
none Participant Scenario List No No Paper Only Form E-Participant Scenario List - CDChomepageUX121613.docx
Individuals or Households 24 24 0

Solve the Outbreak (14GM) No Health Immunization Management
none Questionnaire Yes No Printable Only Form D-Questionnaire -CDC_STOapplication_UX_01_07_2014 - OMB.docx Yes Yes Fillable Fileable Other F-MobileAppScreenshots - CDC_STOapplication__UX_01_07_2014 - OMB.pdf
Individuals or Households 100 50 0

2013-03-20-04:00

0920-0957 201212-0920-006 0920
             
        "Evaluation of the Get Yourself Tested (GYT) Campaign"
             
          
        
This collection of information is proposed to evaluate a communication campaign that encourages youth to be tested for sexually transmitted diseases (STDs), including HIV. Encouraging youth to be tested for STD/HIV is a major goal of the Division of STD Prevention, as these diseases often show no symptoms, but cause long-term consequences. Because the topic is stigmatized and sensitive, communication campaigns involving STD/HIV are difficult to create and sustain. The GYT: Get Yourself Tested campaign has been sustained for multiple years, and there are indications that it is successful; however, the campaign needs to be formally evaluated to determine if it is effective in reaching the target population, and if its messages are understood and acted upon by the target audience. We propose to do this using an established market-research panel (Knowledge Networks) as the study population, selecting 4,000 participants ages 25 and under. Participants have already consented to participate in survey research for the market-research panel; this survey will be included as part of their annual participation in the firm's survey research. 2016-03-31-04:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 4000 2000 0

GYT: Get Yourself Tested No Health Illness Prevention
none GYT: Get Yourself Tested Instrument Yes Yes Fillable Fileable Form Attach 6 SurveyInstrument GYT.docx
Individuals or Households 4000 2000 0

2013-03-20-04:00

0920-0958 201302-0920-016 0920
             
        "Risk Factors for Invasive Methicillin-Resistant Staphylococcus aureus (MRSA) among Patients Recently Discharged from Acute Care Hospitals "
             
          
        
MRSA infections are associated with increased medical costs, morbidity and mortality. MRSA is resistan to first line antimicrobial therapies. Little is known about MRSA risk factors post-discharge. 2015-03-31-04:00 Active Catina Conner 4046394775 No No No 735 133 0

Post-discharge Hospital Patients with MRSA (Case Patients) - Screening and Consent Process No Health Immunization Management Individuals or Households 150 13 0

Post-Discharge Hospital Patients (Case Patients)- Telephone Interview No Health Immunization Management Individuals or Households 95 32 0

Post-discharge Hospital Patients without MRSA Infection (Control-Patients) Screening and Consent No Health Immunization Management Individuals or Households 300 25 0

Post-Discharge Hospital Patients without MRSA infection (Control Patients) Telephone Interview No Health Immunization Management Individuals or Households 190 63 0

2013-03-20-04:00

0920-0959 201301-0920-006 0920
             
        "Hepatitis Testing and Linkage to Care Monitoring and Evaluation System"
             
          
        
The Hepatitis Testing and Linkage to Care Monitoring and Evaluation System is a web-bsed data system to collect standardized, non-identifying, client- and test-level hepatitis testing information from funded testing sites. The data will be used to monitor and evaluate the implementation of hepatitis testing and linkage to care activities and to collect and report on required program performance indicators. 2016-03-31-04:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 640 6000 0

Test-level Data No Health Immunization Management
none Att4.1 HBV- HEPTLC Data Collection Template Yes Yes Fillable Fileable Form and instruction Att4.1 HBV- HEPTLC Data Collection Template.pdf none Att4.2 HCV- HEPTLC Data Collection Template Yes Yes Fillable Fileable Form and instruction Att4.2 HCV- HEPTLC Data Collection Template.pdf Yes Yes Fillable Fileable Instruction Att4 Test Level Data Variables.docx none Att4.3 ScreenShot - HEPTLC Data Collection HBV_HCV Yes Yes Fillable Fileable Form and instruction Att4.3 ScreenShot - HEPTLC Data Collection HBV_HCV.pdf
Private Sector 480 5760 0

Program-level Data No Health Immunization Management
none Program-level Data Yes Yes Fillable Fileable Form and instruction Att5 Programmatic Reporting Template_HEPTLC.xlsx
Private Sector 160 240 0

2013-03-22-04:00

0920-0960 201211-0920-008 0920
             
        "Epidemiologic Study of Health Effects Associated with Low Pressure Events in Drinking Water Distribution Systems"
             
          
        
Approximately 200 million cases of acute gastrointestinal illness (AGI) occur in the U.S. each year. The Centers for Disease Control and Prevention requests approval for data collection to assess whether individuals exposed to low pressure events in water distribution system are at increased risk for acute gastrointestinal or respiratory illnesses. 2016-03-31-04:00 Active Carol Walker 4046394773 No No No 2291 585 0

Web-Based Questionnaire (Pilot and Multi-site) No Health Immunization Management
none Web-based Questionaire Yes Yes Fillable Fileable Form OMB Appendix H Household survey (web version).docx
Individuals or Households 1329 266 0

Paper-Based Questionnaire (Pilot and Mult-site) No Health Immunization Management
none Paper-based Questionaire Yes No Paper Only Form OMB Appendix G Household survey (paper version).pdf
Individuals or Households 886 177 0

LPE Form and Samples ( Multi-Site) No Health Immunization Management
none LPE Form Yes No Paper Only Form OMB Appendix L Low Pressure Event Form.docx
State, Local, and Tribal Governments 35 26 0

Line Listings (Multi-site) No Health Immunization Management
none Line Listings Yes No Fillable Printable Form OMB Appendix L Utility Customer Information.docx
State, Local, and Tribal Governments 35 105 0

LPE Form and Samples (Pilot) No Health Immunization Management
none LPE Form Yes No Paper Only Form OMB Appendix L Low Pressure Event Form.docx
State, Local, and Tribal Governments 3 2 0

Line Listings (Pilot) No Health Immunization Management
none Line Listings Yes No Fillable Fileable Form OMB Appendix L Utility Customer Information.docx
State, Local, and Tribal Governments 3 9 0

2013-03-25-04:00

0920-0961 201305-0920-011 0920
             
        "Proficiency Testing in US Clinical Laboratories: Perception, Practices and Potential for Expanded Utility"
             
          
        
This project is part of a cooperative agreement between the Centers for Disease Control and Prevention (CDC) and the Association of Public Health Laboratories (APHL). The primary focus is to conduct a systematic analysis to understand which types of laboratories follow proficiency testing (PT) good laboratory practices (GLPs) and to identify which kinds of laboratories could be targeted to promote PT GLPs. Based upon prior work conducted by APHL and CDC, it appears that many of these laboratories use their PT results internally for quality improvement. Since laboratories already pay for PT materials to meet regulatory requirements, the use of PT for quality improvement purposes has the potential to further improve laboratory quality at no additional cost to US clinical laboratories. In addition, by conducting this analysis APHL and CDC hope to learn more about the types of laboratories that do not comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) PT requirements. The survey population frame is 20,500 Certificate of Compliance laboratories and 16,800 Certificate of Accreditation laboratories. All of these laboratories are required to perform PT in accordance with CLIA. 2015-04-30-04:00 Active Petunia Gissendaner 4046390164 No No No 29840 9947 0

Proficiency Testing in US Clinical Laboratories: Perception, Practices and Potential for Expanded Utility No Health Consumer Health and Safety
None Proficiency Testing in US Clinical Laboratories: Perception, Practices and Potential for Expanded Utility Yes Yes Fillable Fileable Form and instruction Attachment C_Data collection instrument.pdf
Private Sector 29840 9947 0

2013-05-30-04:00

0920-0963 201310-0920-003 0920
             
        "Colorectal Cancer Control Program Indirect/Non-Medical Cost Study"
             
          
        
CDC is requesting non-substantive changes to this Information Collection Request. Colorectal Cancer (CRC is the second leading cause of cancer-related deaths among adults in the United States (USCS, 2010). The CDC is funding colorectal cancer screening program to increase screening relates among men and women aged 50 years and older. CDC requests approval for a one-year study to collect individual patient-level indirect/non-medical cost data from a subset of patients being screened for CFRC through this program. 2014-04-30-04:00 Active Carol Marsh cww6@cdc.gov 404 639-4773 No No No 615 181 0

Colonoscopy Questionnaire No Health Immunization Management Individuals or Households 315 131 0

FIT Questionnaire No Health Immunization Management Individuals or Households 300 50 0

2013-10-23-04:00

0920-0964 201302-0920-015 0920
             
        "Interventions to Reduce Shoulder MSDs in Overhead Assembly"
             
          
        
Conducted in partnership with Toyota Motor Manufacturing Kentucky, Inc., this study will evaluate the efficacy of two intervention strategies for reducing musculoskeletal symptoms and pain in the shoulder attributable to overhead assembly work in automotive manufacturing. 2015-04-30-04:00 Active Carol Walker 4046394773 No No No 4500 472 0

Informed Consent Form No Workforce Management Worker Safety
none Informed Consent Yes No Fillable Printable Form Attachment F Informed Consent Form.docx
Individuals or Households 125 10 0

Consent of Photographic Image Release No Workforce Management Worker Safety
none Photo Consent Yes No Fillable Printable Form Attachment H Consent of Photographic Image Release.docx
Individuals or Households 125 4 0

Physical Activity Readiness (PAR-Q) No Workforce Management Worker Safety
none PAR-Q Yes No Fillable Printable Form Attachment G1 PAR-Q 8.13.12.docx
Individuals or Households 125 4 0

Shoulder Rating Questionnaire (SRQ) No Workforce Management Worker Safety
none SRQ Yes No Fillable Printable Form Attachment G2 Shoulder Rating Questionnaire.8.13.12docx.docx
Individuals or Households 1250 83 0

Disabilities of the Arm Shoulder and Hand (DASH) No Workforce Management Worker Safety
none DASH Yes No Fillable Printable Form Attachment G3 DASH.docx
Individuals or Households 1250 125 0

Standardized Nordic Questionnaire for Musculoskeletal Symptoms Instrument No Workforce Management Worker Safety
none Standardized Nordic Questionnaire Yes No Fillable Printable Form Attachment G4 8.13.12.docx
Individuals or Households 1250 83 0

Work Organization Questionnaire No Workforce Management Worker Safety
none Work Organization Questionnaire Yes No Fillable Printable Form Attachment G5 Work Organization Questionnaire.docx
Individuals or Households 375 163 0

2013-04-10-04:00

0920-0965 201303-0920-012 0920
             
        "National Healthy Worksite Program"
             
          
        
CDC is establishing a new, comprehensive workplace health program, the National Healthy Worksite Program (NHWP). The purpose of the program is to imporve the health of workers and their families. CDC will work with employers to implement and evaluate workplace-based programs that address physical activity, nutrition, and tobacco use. 2016-05-31-04:00 Active Thelma Sims 4046394771 No Yes No 54878 17747 0

Employer Phone Interview Guide No Health Public Health Monitoring Private Sector 69 23 0

Organizational Assessment (Employer) No Health Public Health Monitoring Private Sector 152 76 0

Employee Eligiblity File Format Requirements No Health Public Health Monitoring Private Sector 152 38 0

Employer Information Form No Health Public Health Monitoring Private Sector 38 19 0

Health Screening Site Interview Form No Health Public Health Monitoring Private Sector 76 38 0

Employer Discussion Guide: Steering Committee Members (Case Studies) No Health Public Health Monitoring Private Sector 115 58 0

Employer Discussion Guide: Wellness Committee (Case Studies) No Health Public Health Monitoring Private Sector 192 96 0

Employer Follow-Up Survey No Health Public Health Monitoring Private Sector 38 10 0

Worksite Health 101 Training Survey: Part I-III No Health Public Health Monitoring Private Sector 115 19 0

Worksite Health 101 Training Survey: Part IV No Health Public Health Monitoring Private Sector 115 19 0

Community Participant Emgagement Feedback Survey No Health Public Health Monitoring Private Sector 40 7 0

Employee Health Assessment No Health Public Health Monitoring Individuals or Households 11426 2857 0

Employee Success Story Consent Form No Health Public Health Monitoring Individuals or Households 76 13 0

Employee Satisfaction Survey No Health Public Health Monitoring Individuals or Households 9140 2285 0

Lower Your Weight by Eight Challenge Log No Health Immunization Management Individuals or Households 2285 2285 0

Step into Health Challenge Log No Health Public Health Monitoring Individuals or Households 2285 1143 0

Maintain Don't Gain Challenge Log No Health Public Health Monitoring Individuals or Households 2285 2285 0

Mix It Up Challenge Log No Health Public Health Monitoring Individuals or Households 2285 1143 0

Quench Your Thirst Challenge Log No Health Public Health Monitoring Individuals or Households 2285 1143 0

Feel Fit with Fiber Challenge Log No Health Public Health Monitoring Individuals or Households 2285 1143 0

Nutrition and Physical Activity Tracker Log / Health Tracker No Health Public Health Monitoring Individuals or Households 2285 1143 0

Health Screening Consent / Contact Form No Health Public Health Monitoring Private Sector 5713 952 0

All Employee Survey No Health Public Health Monitoring Individuals or Households 11426 952 0

2013-05-13-04:00

0920-0966 201302-0920-009 0920
             
        "Costs and Cost Savings of Motor Vehicle Injury Prevention: Evidence-Based Policy and Behavioral Interventions"
             
          
        
The Centers for Disease Control and Prevention (CDC) is seeking approval to conduct research in the area of public health services and systems. Motor vehicle injuries are the leading cause of death for children, adolescents, and young adults, and a major cause of death for all other ages. Motor vehicle injury prevention has been designated as one of the CDC's Winnable Battles. 2014-05-31-04:00 Active Carol Walker 4046394773 No No No 32 64 0

Semi-Structured Interviews - Public Safety Advocacy Groups No Health Immunization Management State, Local, and Tribal Governments 4 4 0

Semi-Structured Interviews - Defense Attorneys No Health Immunization Management State, Local, and Tribal Governments 4 4 0

Semi-Structured Interviews - Court Case Managers No Health Immunization Management State, Local, and Tribal Governments 4 4 0

Semi-Structured Interviews - State Parole Agencies No Health Immunization Management State, Local, and Tribal Governments 2 4 0

Semi-Structured Interviews - State Depts. of Public Safety No Health Immunization Management State, Local, and Tribal Governments 6 36 0

Semi-Structured Interviews - Local Law Enforcement No Health Immunization Management State, Local, and Tribal Governments 4 4 0

Online Expert Panel - Academic Reseachers No Health Consumer Health and Safety Individuals or Households 3 3 0

Online Expert Panel - CDC and NHTSA Staff No Health Immunization Management Federal Government 5 5 0

2013-05-13-04:00

0920-0967 201210-0920-013 0920
             
        "Community Transformation Grants: Evaluation of Nutrition, Physical Activity, and Obesity-related Television Media Campaigns"
             
          
        
CDC plans to conduct a web-based survey to evaluate nutrition, physical activity, and obesity related campaigns conducted as part of CDC's Community Transformation Grant program. The cross-sectional survey will be administered in areas where CTG awardees are conducting media campaigns and in two comparison samples. 2014-05-31-04:00 Active Petunia Gissendaner 4046390164 Yes Yes No 41064 8983 0

Welcome to the Health and Media Survey No Health Public Health Monitoring
None Welcome to the Health and Media Survey Yes Yes Fillable Fileable Form and instruction Attachment 5a_Welcome to the Health and Media Survey.docx None 5b Welcome to the Health and Media Survey Yes Yes Fillable Fileable Form and instruction Attachment 5b (rev) Welcome to the Health and Media Survey Screenshot.pdf
Individuals or Households 25665 1283 0

Health and Media Survey No Health Public Health Monitoring
None Attachment 6b Health and Media Survey Yes Yes Fillable Fileable Form and instruction Attachment 6b (rev) Health and Media Survey Screenshots.pdf None Attachment 6a Health and Media Survey Yes Yes Fillable Fileable Form and instruction Attachment 6a_Health and Media Survey_022613.docx
Individuals or Households 15399 7700 0

2013-05-13-04:00

0920-0968 201303-0920-016 0920
             
        "Monitoring and Reporting System for DELTA FOCUS Awardees"
             
          
        
The purpose of the DELTA FOCUS program is to promote the prevention of Intimate Partner Violence (IPV) through the implementation and evaluation of strategies that create a foundation for the development of practice-based evidence. By emphasizing primary prevention, this program will support comprehensive and coordinated approaches to IPV prevention. The strategies will address the structural determinants of health at the outer layers (societal and community) of the social-ecological model (SEM) that coordinate and align with existing prevention strategies at the inner layers of the SEM. This program addresses the "Healthy People 2020" focus area(s) of Injury and Violence Prevention and Social Determinants of Health 2016-05-31-04:00 Active Thelma Sims 4046394771 No No No 30 210 0

DELTA FOCUS PMIS: Initial population No Health Public Health Monitoring State, Local, and Tribal Governments 10 150 0

DELTA FOCUS PMIS: Semi-annual reporting No Health Public Health Monitoring State, Local, and Tribal Governments 20 60 0

2013-05-22-04:00

0920-0969 201303-0920-005 0920
             
        "Monitoring Changes in Attitudes and Practices among Family Planning Providers and Clinics"
             
          
        
CDC plans to conduct surveys to monitor changes in provider and clinic attitudes and practices over time,partiularly in relationship to the dissemination of recent and future guidelines. Respondents will be health care providers in the private and public sectors, as well as administrators in Title X and Non-Title X clinics. Request is to support phase II data collection. 2014-05-31-04:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 10000 4166 0

Survey of Office-based Physicians in Private Sector No Health Immunization Management
none Provider Survey Screenshots Yes Yes Fillable Fileable Form Phase II Provider Web Survey Screen Shots_Revised 2012-12-18.pdf none Survey of Health Care Providers Yes Yes Fillable Fileable Form D1_Provider Survey_2_25_13.pdf
Private Sector 2000 500 0

Survey of Title X Clinic Providers No Health Immunization Management
none Provider Survey Screenshots Yes Yes Fillable Fileable Form Phase II Provider Web Survey Screen Shots_Revised 2012-12-18.pdf none Survey of Health Care Providers Yes Yes Fillable Fileable Form D1_Provider Survey_2_25_13.pdf
State, Local, and Tribal Governments 2000 500 0

Survey of non-Title X Clinic Providers No Health Immunization Management
none Survey of Health Care Providers Yes Yes Fillable Fileable Form D1_Provider Survey_2_25_13.pdf none Provider Survery Screenshots Yes Yes Fillable Fileable Form Phase II Provider Web Survey Screen Shots_Revised 2012-12-18.pdf
State, Local, and Tribal Governments 2000 500 0

Survey of Title X Clinic Administrators No Health Immunization Management
none Administrator Survey Screenshots Yes Yes Fillable Fileable Form Phase II Administrator Web Survey Screen Shots_Revised 2012-12-18.pdf none Survey of Administrators of Publicly-funded Health Centers that Provide Family Planning Services Yes Yes Fillable Fileable Form E1_Administrator Survey_2_25_13.pdf
State, Local, and Tribal Governments 2000 1333 0

Survey of non-Title X Clinic Administrators No Health Immunization Management
none Survey of Adminstrators of Publicly-Funded Health Centers that Provide Family Planning Services Yes Yes Fillable Fileable Form E1_Administrator Survey_2_25_13.pdf none Administrator Survey Screenshots Yes Yes Fillable Fileable Form Phase II Administrator Web Survey Screen Shots_Revised 2012-12-18.pdf
State, Local, and Tribal Governments 2000 1333 0

2013-05-22-04:00

0920-0970 201303-0920-017 0920
             
        "Assessment of the Psychosocial Impact of Newborn Screening for Congenital Cytomegalovirus (CMV) Infection"
             
          
        
CDC is requesting OMB approval for one year to collect information about newborn congenital cytomegalovirus (CMV) screening. The purpose of this information collection is to understand the psychosocial impact of newborn screening on parents whose infants underwent CMV screening as part of a routine infant CMV screening program in Houston, Texas. The potential study population includes approximately 70 CMV-infected children who were symptomatic at birth, 100 CMV-infected children who were asymptomatic at birth (20 of whom developed sequelae), and 50 controls that were CMV-uninfected. The goals of this information collection are to: 1) document the positive and negative psychosocial impacts of newborn CMV screening on parents and their children; 2) identify modifiable factors that might increase positive psychosocial impacts and decrease negative psychosocial impacts of newborn CMV screening; 3) use what is learned about psychosocial impacts to identify key messages that parents need relative to newborn CMV screening and follow-up; and 4) to learn what challenges are associated with obtaining a congenital CMV diagnosis in the absence of CMV newborn screening. 2014-05-31-04:00 Active Petunia Gissendaner 4046390164 No No No 401 135 0

Parent Focus Group Guide No Health Consumer Health and Safety Individuals or Households 36 54 0

Focus Group Recruitment Letter No Health Consumer Health and Safety Individuals or Households 50 4 0

Parent Interview No Health Consumer Health and Safety Individuals or Households 35 35 0

Interview Recruitment Letter No Health Consumer Health and Safety Individuals or Households 50 4 0

Parent Survey for Parent Groups 1,2,3 & 4 No Health Consumer Health and Safety
None CMV Parent Survey for All Parent Groups Yes Yes Fillable Fileable Form and instruction Attachment 8 Parent Survey--all parents 3-25-13.doc
Individuals or Households 230 38 0

2013-05-22-04:00

0920-0971 201303-0920-015 0920
             
        "Development of an Evaluation Plan to Evaluate Grantee Attainment of Selected Activities of Comprehensive Cancer Priorities"
             
          
        
CDC plans to conduct an online survey and in-person focus groups to assess the extent to which grantees are implementing NCCCP priorities and the extent to which selected CDC capacity-building tools support implementation of these priorities. 2015-05-31-04:00 Active Petunia Gissendaner 4046390164 No No No 89 65 0

National Comprehensive Cancer Control Program Survey No Health Immunization Management
Yes Yes Paper Only Other Att 3B_Survey ScreenShots.pdf None National Comprehensive Cancer Control Program Survey Yes Yes Fillable Fileable Form and instruction Att 3A_Natl Comp Cancer Control Prog Survey_011413_Revised2.docx
State, Local, and Tribal Governments 69 35 0

National Comprehensive Cancer Control Program Focus Groups No Health Immunization Management
Yes No Printable Only Other Att 8_Focus Group Moderator Guide_011413_Revised.docx None Focus Group Consent From Yes No Paper Only Form and instruction Att 12_Focus Group consent form_011413_Revised.doc
State, Local, and Tribal Governments 20 30 0

2013-05-22-04:00

0920-0972 201304-0920-013 0920
             
        "Use of Smartphones to Collect Information about Health Behaviors: Feasibility Study"
             
          
        
CDC is conducting a feasibility study to evaluate the utility of smartphones for collecting information related to tobacco use and other health behaviors from adults in the U.S. 2014-06-30-04:00 Active Carol Walker 4046394773 No No No 5265 306 0

Pre-test CATI Screener/CATI Recruitment No Health Immunization Management
none Pre-test Screener Yes Yes Fillable Fileable Form Appendix C1. Screener - CATI Recruitment.docx none CATI Survey Yes Yes Fillable Fileable Form Appendix D. Initial CATI Survey.docx
Individuals or Households 20 3 0

CATI Screener No Health Immunization Management
none CATI Screener Yes Yes Fillable Fileable Form Appendix C1. Screener - CATI Recruitment.docx
Individuals or Households 1990 33 0

CATI Recruitment No Health Immunization Management
none CATI Survey Yes Yes Fillable Fileable Form Appendix D. Initial CATI Survey.docx
Individuals or Households 1590 186 0

First Web Survey Follow-up for Smartphone Users No Health Immunization Management
none Smartphone Web Survey Follow-up Yes Yes Fillable Fileable Form Appendix E. First Web Survey Follow-up Smartphone Users_4 08 2013.docx
Individuals or Households 700 35 0

Second Web Survey Follow-up for Smartphone Users No Health Immunization Management
none Second Smartphone Survey Yes Yes Fillable Fileable Form Appendix F. Second Web Survey Follow-up for Smartphone Users.doc
Individuals or Households 595 30 0

First Text Message Survey Follow-up for Non-Smartphone Users No Health Immunization Management
none First Text Message Yes Yes Fillable Fileable Form Appendix G. First Text Msg Follow-up for non-SP Users_4 08 2013.docx
Individuals or Households 200 10 0

Second Text Message Follow-up for Non-Smartphone Users No Health Immunization Management
none Second Text Message Survey Yes Yes Fillable Fileable Form Appendix H. Second Text Message Survey Follow-up for non-Smartphone Users.doc
Individuals or Households 170 9 0

2013-06-10-04:00

0920-0973 201303-0920-010 0920
             
        "Exposure Assessment and Epidemiological Study of U.S. Workers Exposed to Carbon Nanotubes and Nanofibers"
             
          
        
The proposed research is a cross-sectional study of the small current workforce involved with CNT and CNF in manufacturing and distribution, to be conducted in the following phases: 1) Industrywide exposure assessment study to evaluate worker exposure and further development and refinement of measurement methods for CNT and CNF, and 2) A cross-sectional study relating various metrics of CNT and CNF exposure (namely, the inhalable fraction of elemental carbon mass concentration, the respirable fraction of elemental carbon mass concentration, and size-classified CNT- or CNF-containing structure counts) to measures of early pulmonary or cardiovascular health effects. 2016-06-30-04:00 Active Carol Walker 4046394773 No No No 99 66 0

Exposure Assessment Questionnaire No Workforce Management Worker Safety
none Questionnaire Yes No Paper Only Form Attachment C-1-questionnaire.docx
Individuals or Households 33 12 0

Informed Consent No Workforce Management Worker Safety
none Consent Yes No Paper Only Form Attachment D-Consent.docx
Individuals or Households 33 11 0

Medical Examination, Biospecimen Collection, and Exposure Monitoring No Workforce Management Worker Safety Individuals or Households 33 43 0

2013-06-10-04:00

0920-0974 201305-0920-009 0920
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery"
             
          
        
The collection of information is necessary to enable the Agency to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with he Agency's programs. 2016-06-30-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 60720 41799 0

Decision and Implementation Support of The Community Guide Website No Health Immunization Management
none Survey No No Paper Only Form and instruction 0920-0974 Attachment B Decision Support- Needs Assessment Script Questions 7-17.docx
State, Local, and Tribal Governments 25 25 0

2013-06-12-04:00

0920-0975 201306-0920-012 0920
             
        "Virtual Reality to Train and Assess Emergency Responders"
             
          
        
The present research project seeks to determine optimal use of virtual reality (VR) technologies for training and assessing mine emergency responders using the Mine Rescue and Escape Training Laboratory (MRET Lab). Responders include specially trained individuals, such as mine rescue or fire brigade team members, and also managers and miners who may either be called upon to respond to an emergency situation or engage in self-protective actions in response to an emergency. This project is a step toward determining how new immersive virtual reality technologies should be used for miner training and testing in the US. The project objective will be achieved through specific aims in two related areas as illustrated below. Training assessment 1.Evaluate four training modules 2.Evaluate participant reactions 3.Develop guidelines Training development 4.Use 3D technologies to develop a prototype for a mine rescue closed-circuit breathing apparatus (e.g., Dr?ger BG4). 2016-07-31-04:00 Active Petunia Gissendaner 4046390164 No No No 510 32 0

Dr?ger BG4 participants: Post-Training Questionnaire No Workforce Management Worker Safety
None Dr?ger BG4 participants: Post-Training Questionnaire Yes No Paper Only Form Attachment C1.docx
Individuals or Households 30 2 0

Mine Rescue Participants: Pre-Training Questionnaire No Workforce Management Worker Safety
None Mine Rescue participants: Pre-Training Questionnaire Yes No Paper Only Form Att C7 Mine Rescue Pre_Trng.docx
Individuals or Households 60 3 0

Mine Rescue participants: Post-Simulation Questionnaire No Workforce Management Worker Safety
None Mine Rescue participants: Post-Simulation Questionnaire Yes No Paper Only Form and instruction Att C8 Mine Rescue Post_Simulation.docx
Individuals or Households 60 3 0

Mine Rescue participants: Post-Training Questionnaire No Workforce Management Worker Safety
None Mine Rescue participants: Post-Training Questionnaire Yes No Paper Only Form and instruction Att C9 Mine Rescue Post_Trng.docx
Individuals or Households 60 3 0

Mine Escape participants: Pre-Training Questionnaire No Workforce Management Worker Safety
None Mine Escape participants: Pre-Training Questionnaire Yes No Paper Only Form Att C2 Mine Escape-Pretraining.docx
Individuals or Households 60 3 0

Mine Escape participants: Post-Simulation Questionnaire No Workforce Management Worker Safety
None Mine Escape participants: Post-Simulation Questionnaire Yes No Paper Only Form and instruction Att C3 Mine Escape-Post-Simulation.docx
Individuals or Households 60 3 0

Mine Escape participants: Post-Training Questionnaire No Workforce Management Worker Safety
none Mine Escape participants: Post-Training Questionnaire Yes No Paper Only Form and instruction Att C4 Mine Escape-Post-Training.docx
Individuals or Households 60 3 0

Mine Escape/Longwall Mining participants: Pre/Post-Training Knowledge Test No Workforce Management Worker Safety
none Mine Escape/Longwall Mining participants: Pre/Post-Training Knowledge Test Yes No Paper Only Form and instruction Att C6 Mine Escape Longwall Pre_Post Trng.docx
Individuals or Households 30 3 0

Mine Escape/Continuous Mining participants: Pre/Post-Training Knowledge Test No Workforce Management Worker Safety
none Mine Escape/Continuous Mining participants: Pre/Post-Training Knowledge Test Yes No Paper Only Form and instruction Att C5 Mine Escape Continuous Pre_ Post Trng.docx
Individuals or Households 30 3 0

Mine Rescue/Longwall Mining participants: Pre/Post-Training Knowledge Test No Workforce Management Worker Safety
none Mine Rescue/Longwall Mining participants: Pre/Post-Training Knowledge Test Yes No Paper Only Form and instruction Att C11 Mine Rescue Longwall Mining Pre_Post Trng Know.docx
Individuals or Households 30 3 0

Mine Rescue/Continuous Mining participants: Pre/Post-Training Knowledge Test No Workforce Management Worker Safety
none Mine Rescue/Continuous Mining participants: Pre/Post-Training Knowledge Test Yes No Paper Only Form and instruction Att C10 Mine Rescue_Contin Mining Pre_Post Trng Know.docx
Individuals or Households 30 3 0

2013-07-26-04:00

0920-0976 201305-0920-008 0920
             
        "Million Hearts Hypertension Control Challenge"
             
          
        
The Centers for Disease Control and Prevention (CDC) is offering a Challenge to identify and recognize clinical care providers, including healthcare systems, that have resulted in exemplary levels of blood pressure control in their patient populations. 2016-07-31-04:00 Active Carol Walker 4046394773 No No No 1795 958 0

Nomination Form No Health Immunization Management
none Website Screenshots Yes Yes Fillable Fileable Form Attachment 6 Screenshots 7-24-2013.pdf none Nomination Form Yes Yes Fillable Fileable Form Attachment 3a Nomination Form_7 23 2013.docm
Private Sector 1735 868 0

Data Verification Form No Health Immunization Management
none Data Verification Yes Yes Fillable Fileable Form Attachment 4. Verification Form_4 4 2013.docm
Private Sector 30 30 0

Interview Guide No Health Immunization Management Private Sector 30 60 0

2013-07-31-04:00

0920-0977 201305-0920-002 0920
             
        "Targeted Surveillance and Biometric Studies for Enhanced Evaluation of CTGs"
             
          
        
CDC plans to conduct a study to collect key outcomes required by the ACA in up to 20 selected areas funded through the Community Transformation Grants Program. This is a population-based household assessment of persons 3 years of age and older who live in 20 CTG areas that are implementing interventions. Adults will be asked to complete an Adult Targeted Surveillance Survey as part of a standard protocol. A sample of househoulds from 8 of the areas will be selected to participate in an enhanced protocol that involves an in-home visit to collect biometric measures. All participants will be administered a questionnaire to assess core ACA outcomes. 2016-08-31-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No Yes No 40164 11360 0

Adult Targeted Surveillance Survey - paper No Health Immunization Management
none Survey Booklet - Spanish No No Paper Only Form Att 7A-S_ATSS_PaperBooklet_SP.pdf none Survey Booklet No No Paper Only Form Att 7A_ATSS_PaperBooklet.pdf
Individuals or Households 8485 4243 0

Adult Biometric Measures - screener No Health Immunization Management
none Adult Biometric Measures Recruitment Screener - Spanish No No Paper Only Form Att 10C-S_AdultBio_PaperInvitation_Screener_CallIns_SP.docx none Adult Biometric Measures Recruitment Screener-Spanish Yes Yes Fillable Fileable Form Att 10A-S_AdultBio_Screener_PostCATI_SP.docx none Adult Biometric Measures Recruitment Screener No No Paper Only Form Att 10C_AdultBio_PaperInvitation_Screener_CallIns.docx none Adult Biometric Measures Recruitment Screener Yes Yes Fillable Fileable Form Att 10A_AdultBio_Screener_PostCATI.docx
Individuals or Households 4418 736 0

Adult Biometric Measures Recruitment Screener (In-person) No Health Immunization Management
none Biometric Screener in-person Yes Yes Fillable Fileable Form Att 11F_ Adult BioMeas Screener.docx none Spanish Biometric Screener in-person Yes Yes Fillable Fileable Form Att S11F_Adult BioMeas Screener Spanish.docx
Individuals or Households 0 0 0

Adult Targeted Surveillance Survey - Telephone Interview No Health Immunization Management
none Adult Targeted Surveillance Survey - phone interview Spanish Yes Yes Fillable Fileable Form Att 7C-S_ATSS_PhoneInterview_SP.docx none Adult Targeted Surveillance Survey - phone interview Yes Yes Fillable Fileable Form Att 7C_ATSS_PhoneInterview.docx
Individuals or Households 7311 3412 0

Adult Biometric Measures No Health Immunization Management
none Adult Biometric Measures Yes Yes Fillable Fileable Form Att 12A_AdultBioMeasures.docx none Adult Biometric Measures - Spanish Yes Yes Fillable Fileable Form Att 12A-S_AdultBioMeasures_SP.docx
Individuals or Households 2667 1334 0

Adult Activity Diary No Health Immunization Management
none Adult Activity Diary - Spanish No No Paper Only Form Att 13B-S_AdultActivityDiary_SP.doc none Adult Activity Diary No No Paper Only Form Att 13B_AdultActivityDiary.doc
Individuals or Households 167 56 0

Caregiver Survey Recruitment Screener No Health Immunization Management
none Caregiver Screener Yes Yes Fillable Fileable Form Att 11E_Caregiver Screener.docx none Spanish Caregiver Screener Yes Yes Fillable Fileable Form Att S11E_ Caregiver Screener Spanish.docx
Individuals or Households 0 0 0

Caregiver Survey No Health Immunization Management
none Caregiver Survey Yes Yes Fillable Fileable Form Att 9A_CaregiverSurvey.docx none Caregiver Survey - Spanish Yes Yes Fillable Fileable Form Att 9A-S_CaregiverSurvey_SP.docx
Individuals or Households 960 320 0

Youth Activity Diary - completed by caregiver No Health Immunization Management
none Youth Activity Diary No No Paper Only Form Att 13C_YouthActivityDiary.docx none Youth Activity Diary - Spanish No No Paper Only Form Att 13C-S_YouthActivityDiary_SP.doc
Individuals or Households 100 33 0

Youth Biometric Measures No Health Immunization Management
none Youth Biometric Measures - Spanish Yes Yes Fillable Fileable Form Att 12B-S_YouthBioMeasures_SP.doc none Youth Biometric Measures Yes Yes Fillable Fileable Form Att 12B_YouthBioMeasures.doc
Individuals or Households 1600 533 0

Youth Activity Diary - completed by youth No Health Immunization Management
none Youth Activity Diary - Spanish No No Paper Only Form Att 13C-S_YouthActivityDiary_SP.doc none Youth Activity Diary No No Paper Only Form Att 13C_YouthActivityDiary.docx
Individuals or Households 67 22 0

Youth Survey Recruitment Screener for Youth No Health Immunization Management
none Spanish Survey Recruitment Screener for Youth Yes Yes Fillable Fileable Form Att S11D_Youth Screener(12-17) Spanish.docx none Survey Recruitment Screener for Youth Yes Yes Fillable Fileable Form Att 11D_YouthSurvey Screener.docx
Individuals or Households 0 0 0

Youth Survey No Health Immunization Management
none Youth Survey - Spanish Yes Yes Fillable Fileable Form Att 9B-S_YouthSurvey_SP.docx none Youth Survey Yes Yes Fillable Fileable Form Att 9B_YouthSurvey.docx
Individuals or Households 640 213 0

Adult Targeted Surveillance Survey - screener No Health Immunization Management
none Adult Targeted Surveillance Survey telephone screener- Spanish Yes Yes Fillable Fileable Form Att 7C-S_ATSS_PhoneInterview_SP.docx none Adult Targeted Surveillance Survey - telephone screener Yes Yes Fillable Fileable Form Att 7C_ATSS_PhoneInterview.docx
Individuals or Households 13749 458 0

2013-08-16-04:00

0920-0978 201309-0920-007 0920
             
        "Emerging Infections Program"
             
          
        
CDC is requesting changes to this Information Collection. The Emerging Infections Programs (EIPs) are population-based centers of excellence established through a network of state health departments collaborating with academic institutions; local health departments; public health and clinical laboratories; infection control professionals; and healthcare providers. EIPs assist in local, state, and national efforts to prevent, control, and monitor the public health impact of infectious diseases. Activities of the EIPs fall into the following general categories: (1) active surveillance; (2) applied public health epidemiologic and laboratory activities; (3) implementation and evaluation of pilot prevention/intervention projects; and (4) flexible response to public health emergencies. Activities of the EIPs are designed to: (1) address issues that the EIP network is particularly suited to investigate; (2) maintain sufficient flexibility for emergency response and new problems as they arise; (3) develop and evaluate public health interventions to inform public health policy and treatment guidelines; (4) incorporate training as a key function; and (5) prioritize projects that lead directly to the prevention of disease. 2016-08-31-04:00 Active Carol Marsh cww6@cdc.gov 404 639-4773 No No No 41200 12319 0

ABCs Case Report Form No Health Immunization Management
none Case Report Yes Yes Fillable Fileable Form Attachment 2_2013_ABCs CRF.pdf
State, Local, and Tribal Governments 8090 2697 0

Invasive Methicillin - Resistant - Staphylococcus aureus ABCs Case Report Form No Health Immunization Management
none Invasive MRSA Yes No Fillable Fileable Form Attachment 3_2013_ABCs_MRSA_CRF.pdf
State, Local, and Tribal Governments 6090 2030 0

ABCs Invasive Pneumococcal Disease in Children No Health Immunization Management State, Local, and Tribal Governments 410 68 0

ABCs Neonatal Infection Expanded Tracking Form No Health Immunization Management
none Neonatal Infection Yes Yes Fillable Fileable Form Attachment 4_2013_ABCs Extended Neonatal Infection CRF.pdf
State, Local, and Tribal Governments 370 123 0

2013 Legionellosis ABCs Case Report No Health Immunization Management
none Legionellosis Yes Yes Fillable Fileable Form Attachment 5_2013_ABCs Legionellosis CRF.pdf
State, Local, and Tribal Governments 1000 333 0

2011-12 FluSurv-NET Influenza Hospitalization Surveilance Project Case Report Form No Health Immunization Management State, Local, and Tribal Governments 4000 1000 0

Hemolytic Uremic Syndrome (HUS) No Health Immunization Management State, Local, and Tribal Governments 100 100 0

Influenza Hospitalization Surveillance Project Vaccination Telephone Survey No Health Immunization Management State, Local, and Tribal Governments 1000 83 0

Consent Form No Health Immunization Management State, Local, and Tribal Governments 1000 83 0

Campylobacter No Health Immunization Management State, Local, and Tribal Governments 6370 2123 0

Cryptosporidium No Health Immunization Management State, Local, and Tribal Governments 1300 217 0

Cyclospora No Health Immunization Management State, Local, and Tribal Governments 30 5 0

Listeria monocytogenes No Health Immunization Management State, Local, and Tribal Governments 130 43 0

Salmonella No Health Immunization Management State, Local, and Tribal Governments 8270 2757 0

Shiga toxin producing E. coli No Health Immunization Management State, Local, and Tribal Governments 900 300 0

Shigella No Health Immunization Management State, Local, and Tribal Governments 1780 297 0

Vibrio No Health Immunization Management State, Local, and Tribal Governments 200 33 0

Yersinia No Health Immunization Management State, Local, and Tribal Governments 160 27 0

2013-09-26-04:00

0920-0979 201306-0920-011 0920
             
        "Spectrum of Flavoring Chemical-Related Lung Disease"
             
          
        
The National Institute for Occupational Safety and Health (NIOSH) is conducting a medical survey of flavoring-exposed workers as part of the NORA-funded research project, Spectrum of Flavoring Chemical-Related Lung Disease. The purpose of this project is to characterize the nature of restrictive lung disease occurring in popcorn and flavoring workers. The significance of this work is that past conclusions about emerging lung disease hazards in flavoring-exposed workers can be extended, if necessary, to the full range of conditions that employees, physicians, companies, and regulators must take into account in their efforts to prevent the burden of disease associated with flavorings. Respondents to this survey will be from two populations of workers: those who participated in a previous NIOSH survey at a microwave popcorn plant, and those at a flavoring manufacturing plant that had a high prevalence of restriction. The study will involve a questionnaire, lung function tests, high-resolution computed tomography (HRCT), and blood collection. It is anticipated that it will take approximately no more than 3.5 hours to complete the job and medication history forms, NIOSH testing, and the HRCT. Participants will receive a letter with the results of their own medical testing, and we plan to publish and present overall study results after data collection. 2015-08-31-04:00 Active Thelma Sims 4046394771 No No No 548 105 0

Flavoring workers - Job History Form No Workforce Management Worker Safety Individuals or Households 56 7 0

Popcorn workers - Questionnaire No Health Illness Prevention Individuals or Households 81 27 0

Popcorn workers - Informed Consent No Workforce Management Worker Safety Individuals or Households 81 14 0

Popcorn workers - Medication Form No Workforce Management Worker Safety Individuals or Households 81 11 0

Flavoring workers - Medication Form No Workforce Management Worker Safety Individuals or Households 56 7 0

Flavoring workers - Informed Consent No Workforce Management Worker Safety Individuals or Households 56 9 0

Popcorn workers - Job History Form No Workforce Management Worker Safety Individuals or Households 81 11 0

Flavoring workers - Questionnaire No Health Illness Prevention Individuals or Households 56 19 0

2013-08-23-04:00

0920-0980 201304-0920-007 0920
             
        "National Voluntary Environmental Assessment Information System"
             
          
        
Foodborne illness outbreaks are a significant problem in the U.S. Reducing the number of these outbreaks requires identification and understanding of the environmental factors that cause these outbreaks. CDC has developed the National Voluntary Environmental Assessment Information System (NVEAIS) to obtain data from environmental assessments routinely conducted by food safety program officials in response to foodborne illness outbreaks will be reported. The data reported will provide timely information on the causes of outbreaks, including environmental factors associated with outbreaks. 2016-08-31-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 8400 6067 0

NVEAIS Data Reporting Instrument No Health Immunization Management
none NVEAIS Screenshots Yes Yes Fillable Fileable Form Att7- Sample Screenshots of the Web-based NVEAIS 20130321.docx none NVEAIS Data Reporting Instrument Yes Yes Fillable Fileable Form Att4-NVEAIS Data Reporting Instrument 20130321.doc
State, Local, and Tribal Governments 1400 1400 0

NVEAIS Manager Interview No Health Immunization Management
none Manager Interview Yes No Fillable Printable Form Att5-NVEAIS Manager Interview 20130321.doc
Private Sector 5600 1867 0

Food Safety Program Training No Health Immunization Management State, Local, and Tribal Governments 1400 2800 0

2013-08-23-04:00

0920-0981 201306-0920-013 0920
             
        "Assessing and Evaluating Human Systems Integration Needs in Mining"
             
          
        
With the second highest fatal injury rate, mining remains one of the most dangerous occupations in the United States. Despite continued research and regulation on technology-based solutions, tragedies like Upper Big Branch (2010) and Sago (2006) still highlight a lack of consideration for the human component. Human Systems Integration (HSI) incorporates the needs of any human interaction within the system into the design process to optimize both safety and efficiency of the system. Currently, the mining industry lacks a similar set of guidelines to ensure both usability by the miner and increased safety of the mining working environment. This research project will use an HSI approach to answer a series of questions because HSI is based on the understanding that people are the critical elements within systems and adopting a human-centric perspective of systems increases productivity and safety, while decreasing costs (Tvaryanas, 2006). The goal of this project is to determine: (1) what information is critical for a miner to safely perform his job, (2) what processes (e.g., expertise, decision making, attention, etc.) are necessary for a miner to effectively perform his job, and (3) how the miner and the machine interact. 2015-08-31-04:00 Active Petunia Gissendaner 4046390164 No No No 1310 442 0

NIOSH Model Informed Consent Form No Workforce Management Worker Safety
None NIOSH Model Informed Consent Form Yes No Paper Only Form and instruction Appendix Q_NIOSHModelInformedConsentForm.doc
Private Sector 285 24 0

Talent Waiver No Workforce Management Worker Safety Private Sector 285 10 0

Demographic Questionnaire No Workforce Management Worker Safety
None Demographic Questionnaire Yes No Paper Only Form Appendix S.docx
Private Sector 285 10 0

Task and Cognitive Task Analysis: Continuous Miner No Workforce Management Worker Safety
None Task and Cognitive Task Analysis: Continuous Miner Yes No Paper Only Form Appendix D_Task and Cognitive Task Analysis_CM Operator.docx
Private Sector 10 20 0

Task and Cognitive Task Analysis: Fire Boss No Workforce Management Worker Safety
None Task and Cognitive Task Analysis: Fire Boss Yes No Paper Only Form Appendix E_Task and Cognitive Task Analysis_Fire boss.docx
Private Sector 10 20 0

Direct Observation: Continuous Miner Operator No Workforce Management Worker Safety
None Direct Observation: Continuous Miner Operator Yes No Paper Only Form Appendix C1_Direct Observation.docx None Informed Consent Yes No Paper Only Form and instruction Appendix K_Direct Observation Consent and Consent Script.docx
Private Sector 10 40 0

Direct Observation: Fire Boss No Workforce Management Worker Safety
None Direct Observation: Fire Boss Yes No Paper Only Form Appendix C2_Direct Observation.docx
Private Sector 10 40 0

General Preference Questionnaire No Workforce Management Worker Safety
None General Preference Questionnaire Yes No Paper Only Form and instruction Appendix G_General Preference Questionnaire.docx
Private Sector 75 38 0

Subject Matter Expert Questionnaire No Workforce Management Worker Safety
None Subject Matter Expert Questionnaire Yes No Paper Only Form and instruction Appendix F_Subject Matter Expert Questionnaire.docx
Private Sector 50 50 0

Safety Director Questionnaire No Workforce Management Worker Safety
None Safety Director Questionnaire Yes No Paper Only Form and instruction Appendix H_Safety Director Questionnaire.docx
Private Sector 50 25 0

Roof Bolter Questionnaire No Workforce Management Worker Safety
None Roof Bolter Questionnaire Yes No Paper Only Form and instruction Appendix I_Roof bolter Questionnaire pre and post.doc
Private Sector 60 15 0

Vest Usability Testing No Workforce Management Worker Safety
None Field Evaluation Informed Consent Yes No Paper Only Form and instruction Appendix L_Vest Study Consent and Consent Script.docx None Vest Usability Testing Yes No Paper Only Form and instruction Appendix J_Vest Questionnaire Pre and Post.docx
Private Sector 120 90 0

Focus Groups No Workforce Management Worker Safety Private Sector 30 30 0

Lab Experiments No Workforce Management Worker Safety Private Sector 30 30 0

2013-08-29-04:00

0920-0982 201401-0920-004 0920
             
        "Salt Sources Study"
             
          
        
CDC plans to conduct a two-year study to obtain current, accurate information about sources of dietary sodium including sodium inherent in foods, sodium in processed and restaurant foods, and salt added to food at the table and during cooking. Information will be collected from diverse groups of adults at three study sites in three distinct geographic regions. Minor changes are requested to several forms after a pilot period. 2015-09-30-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 4890 1372 0

Discretionary Salt Use No Health Immunization Management
None Discretionary Salt Use Questions from NHANES 2009 Yes No Paper Only Form Att 6_Discretionary Salt Use Questions from NHANES 2009.doc
Individuals or Households 225 19 0

Telephone Recruitment and Screening No Health Immunization Management
none 4a - Telephone recruitment and screening No No Fillable Printable Form and instruction Att 4A_Telephone Recruitment and Screening Script_01082014.docx
Individuals or Households 225 38 0

Participant Questionnaire No Health Immunization Management
none Participant Questionnaire Yes No Paper Only Form Att 5_Participant Questionnaire_8_28_2013.docx
Individuals or Households 225 38 0

Height and Weight Data Collection No Health Immunization Management
None Height and Weight Form Yes No Paper Only Form Att 7_Height and Weight Form and Procedures.doc
Individuals or Households 225 38 0

Study Orientation No Health Immunization Management Individuals or Households 225 75 0

Home Tap Water Questionnaire No Health Immunization Management
none Home Tap Water Questionnaire Yes No Paper Only Form Att 10A1_Home Tap Water Questionnaire_01082014.docx
Individuals or Households 225 19 0

24-Hour Dietary Recall Interview No Health Immunization Management
none 24-hour Dietary Recall Yes No Paper Only Form Att 11A_24 Hour Dietary Recall Interview_0108014.doc
Individuals or Households 900 450 0

Food Record Form No Health Immunization Management
none Food Record Yes No Paper Only Form Att 12A_Food Record Form_01082014.docx
Individuals or Households 900 225 0

Duplicate Salt Sample Collection No Health Immunization Management
none Bag Label Salt Added in Food Prep Yes No Paper Only Form Att 14A1_Bag Label Salt Added in Food Preparation_01082014.doc none Bag Label Salt Added at the Table No No Paper Only Form Att 13A1_Bag Label Salt Added at the Table_01082014.doc
Individuals or Households 900 150 0

Water Collection No Health Immunization Management Individuals or Households 15 1 0

24-Hour Urine Collection No Health Immunization Management
none 24-hour Urine Collection Yes No Paper Only Form Att 15A_24hr Urine Collection Form_01082014.doc
Individuals or Households 300 250 0

Follow-Up Urine Collection Questionnaire No Health Immunization Management
none Salt Sources Study--Follow-up Urine Collection Questionnaire Yes No Paper Only Form Att 16A_Follow-Up Urine Collection Questionnaire8_28_2013.doc
Individuals or Households 300 50 0

Study Salt Supplement Questionnaire No Health Immunization Management
none Study Salt Questionnaire Yes No Paper Only Form Att 17A_Study Salt Questionnaire_01082014.docx
Individuals or Households 225 19 0

2014-01-13-05:00

0920-0983 201304-0920-011 0920
             
        "Research to Inform the Prevention of Asthma in Healthcare"
             
          
        
The National Institute for Occupational Safety and Health (NIOSH) is requesting to field a survey to identify modifiable risk factors for asthma among workers in the healthcare industry. 2015-09-30-04:00 Active Carol Walker 4046394773 No No No 2503 1255 0

Certified Nursing Assistants - Online Survey No Health Consumer Health and Safety
none Survey Web version Yes Yes Fillable Fileable Form Appendix M_(3).docx
Individuals or Households 149 75 0

Central Supply Workers - Online Survey No Health Consumer Health and Safety
none Online Survey Yes Yes Fillable Fileable Form Appendix M_(3).docx
Individuals or Households 4 2 0

Dental Assistants - Online Survey No Health Consumer Health and Safety
none Online Survey Yes Yes Fillable Fileable Form Appendix M_(3).docx
Individuals or Households 9 5 0

Environmental Service Workers - Online Survey No Health Consumer Health and Safety
none Online Survey Yes Yes Fillable Fileable Form Appendix M_(3).docx
Individuals or Households 114 57 0

Licensed Practical Nurses - Online Survey No Health Consumer Health and Safety
none Online Survey Yes Yes Fillable Fileable Form Appendix M_(3).docx
Individuals or Households 70 35 0

Lab Technicians - Online Survey No Health Consumer Health and Safety
none Online Survey Yes Yes Fillable Fileable Form Appendix M_(3).docx
Individuals or Households 39 20 0

Operating Room Technicians - Online Survey No Health Consumer Health and Safety
none Online Survey Yes Yes Fillable Fileable Form Appendix M_(3).docx
Individuals or Households 14 7 0

Registered Nurses - Online Survey No Health Consumer Health and Safety
none Online Survey Yes Yes Fillable Fileable Form Appendix M_(3).docx
Individuals or Households 84 42 0

Respiratory Therapist - Online Survey No Health Consumer Health and Safety
none Online Survey Yes Yes Fillable Fileable Form Appendix M_(3).docx
Individuals or Households 18 9 0

Certified Nursing Assistants - Telephone Survey No Health Consumer Health and Safety
none Telephone Survey Yes Yes Fillable Fileable Form Appendix K_(3).docx.doc
Individuals or Households 594 297 0

Central Supply Workers - Telephone Survey No Health Consumer Health and Safety
none Telephone Survey Yes Yes Fillable Fileable Form Appendix K_(3).docx.doc
Individuals or Households 17 9 0

Dental Assistants - Telephone Survey No Health Consumer Health and Safety
none Telephone Survey Yes Yes Fillable Fileable Form Appendix K_(3).docx.doc
Individuals or Households 36 18 0

Environmental Service Workers - Telephone Survey No Health Consumer Health and Safety
none Telephone Survey Yes Yes Fillable Fileable Form Appendix K_(3).docx.doc
Individuals or Households 457 229 0

Licensed Practical Nurses - Telephone Survey No Health Consumer Health and Safety
none Telephone Survey Yes Yes Fillable Fileable Form Appendix K_(3).docx.doc
Individuals or Households 280 140 0

Lab Technicians - Telephone Survey No Health Consumer Health and Safety
none Telephone Survey Yes Yes Fillable Fileable Form Appendix K_(3).docx.doc
Individuals or Households 155 78 0

Operating Room Technicians - Telephone Survey No Health Consumer Health and Safety
none Telephone Survey Yes Yes Fillable Fileable Form Appendix K_(3).docx.doc
Individuals or Households 55 28 0

Registered Nurses - Telephone Survey No Health Consumer Health and Safety
none Telephone Survey Yes Yes Fillable Fileable Form Appendix K_(3).docx.doc
Individuals or Households 336 168 0

Respiratory Therapists - Telephone Survey No Health Consumer Health and Safety
none Telephone Survey Yes No Fillable Fileable Form Appendix K_(3).docx.doc
Individuals or Households 72 36 0

2013-09-06-04:00

0920-0984 201307-0920-006 0920
             
        "DELTA FOCUS Program Evaluation"
             
          
        
The Centers for Disease Control and Prevention seeks approval to evaluate awardees under the DELTA FOCUS (Domestic Violence Prevention Enhancement and Leadership Through Alliances, Focusing on Outcomes for Communities United with States) program. 2014-09-30-04:00 Active Carol Walker 4046394773 No No No 49 49 0

DELTA FOCUS Survey No Health Immunization Management
none DELTA FOCUS Survey Yes Yes Fillable Fileable Form Attachment 3a Survey Instrument - Screenshots.pdf
State, Local, and Tribal Governments 49 49 0

2013-09-06-04:00

0920-0985 201305-0920-006 0920
             
        "Returning our Veterans to Employment and Reintegration (ROVER): National Surveys of Assistance Dog Providers and Veterans"
             
          
        
There is a great need for studies that examine specific aspects of human-animal interactions that may be effective in improving general quality of life and enhancing ability to work. Although reports of the positive impact of assistance animals are ubiquitous in the popular press, few studies have been conducted on the use of assistance dogs to help and support Veterans with physical and psychological disabilities return to employment. Furthermore, investigations are needed to document the specific roles or functions of assistance dogs that might be useful, not only for helping Veterans return to work, but also for reducing or ameliorating some of the symptoms PTSD and other psychological barriers. The survey of assistance dog providers is designed to gather information from providers and trainers of assistance animals about the services they provide to address Veterans and employment issues. 2015-09-30-04:00 Active Petunia Gissendaner 4046390164 No No No 7100 6284 0

Assistance Dog Provider Recruitment Email No Workforce Management Worker Safety Private Sector 700 117 0

Assistance Dog Providers Survey No Workforce Management Worker Safety
none Assistance Dog Providers Survey Yes Yes Fillable Fileable Form and instruction Attachment C Provider Survey13 1 2.doc
Private Sector 300 150 0

Veterans Agency--Announcement Emails No Workforce Management Worker Safety Private Sector 100 17 0

A National Survey of Veterans No Workforce Management Worker Safety
None A National Survey of Veterans Yes Yes Fillable Fileable Form and instruction Attachment D.pdf
Private Sector 6000 6000 0

2013-09-09-04:00

0920-0986 201308-0920-006 0920
             
        "Mixed-methods Information Collection on Emerging Diseases among Foreign-born in the US"
             
          
        
This generic will allow DGMQ to collect critical information for planning and implementation of disease prevention and control strategies among high risk foreign-born communities. Foreign-born individuals are hard to reach populations and often missed by routine data collection systems. There is limited information about the health status, beliefs and practices and risk factors for communicable diseases and other health issues, especially at the local level. 2016-09-30-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 56700 21150 0 2013-09-09-04:00

0920-0987 201308-0920-007 0920
             
        "Qualitative Information Collection on Emerging Diseases among the Foreign-born in the US"
             
          
        
This will allow DGMQ to collect critical qualitative information on knowledge, attitudes, health beliefs and practices related to emerging health issues amonth high risk foreign-born populations in the US. It is needed for planning and implementation of disease prevention and control strategies among those communities in specific and limited geographic areas. 2016-09-30-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 3075 2475 0 2013-09-12-04:00

0920-0988 201304-0920-014 0920
             
        "Science to Practice:  Developing and Testing a Marketing Strategy for Preventing Alcohol-related Problems in College Communities"
             
          
        
Each year, 1,700 college students die and more than 1.4 million are injured in alcohol-related incidents. Additionally, about 25% of students report negative academic consequences due to alcohol. Despite the enormous public health burden of college-age alcohol misuse, there have been few rigorous evaluations of environmental strategies to address alcohol misuse in college settings; environmental strategies typically involve implementing and enforcing policies that change the environments that influence alcohol-related behavior and subsequent harm. Further, studies show that the typical lag time between identifying an effective intervention and obtaining widespread adoption can stretch to well over a decade. There is an urgent need to develop more efficient and timely strategies for moving effective science to widespread practice. This project will address this exact issue by systematically developing a marketing strategy for a comprehensive, community-based environmental prevention program with proven efficacy in reducing intoxication and alcohol-impaired driving among college students. 2015-04-30-04:00 Active Thelma Sims 4046394771 No No No 1800 1800 0

Questionnaire - College Administrators No Health Health Care Services Private Sector 600 600 0

Questionnaire - Police Officers No Health Health Care Services Private Sector 600 600 0

Questionnaire - Community Leaders No Health Health Care Services Private Sector 600 600 0

2013-09-20-04:00

0920-0989 201308-0920-001 0920
             
        "CDC Work@Health Program: Phase 1"
             
          
        
CDC plans to conduct employer training needs assessment survey and an evaluation of pilot training models prior to implementing a full scale Work@Health training program. 2014-09-30-04:00 Active Carol Walker 4046394773 No Yes No 660 117 0

Interested Employer - Training Needs Assessment Survey No Health Immunization Management
none Training Needs Assessment Yes Yes Fillable Fileable Form Attachment D-2_Screen Shots Training Needs Assessment Survey_6-27-13.doc
Private Sector 200 67 0

Interested Employer - Pilot Employer Application Form No Health Immunization Management
none Pilot Employer Application Form Yes Yes Fillable Fileable Form Attachment I-2_Screen Shots Pilot Employer Application Form_6-27-13.doc
Private Sector 400 33 0

Interested Employer - Pilot Training Hands-on Model Evaluation Survey No Health Immunization Management
none Pilot Training Hands On Yes No Paper Only Form Attachment E_Hands-on Eval Survey_6-25-13.doc
Private Sector 15 4 0

Participating Employer - Pilot Training: Online Model Evaluation Survey No Health Immunization Management
none Online Pilot Screenshots Yes Yes Fillable Fileable Form Attachment F-2_Screen Shots Online Pilot Eval_6-27-13.doc
Private Sector 15 4 0

Participating Employer - Pilot Training: Blended Model Evaluation Survey No Health Immunization Management
none Blended Evaluation Survey Yes No Paper Only Form Attachment G_Blended Eval Survey_6-25-13.doc
Private Sector 15 5 0

Participating Employer - Pilot Training: Train-the-Trainer Evaluation Survey No Health Immunization Management
none Train-the-Trainer Evaluation Survey Yes No Printable Only Form Attachment H_Train-the-Trainer Eval Instrument_6-25-13.doc
Private Sector 15 4 0

2013-09-23-04:00

0920-0990 201306-0920-009 0920
             
        "Formative Research, Messages and Materials Development for NCBDDD"
             
          
        
NCBDDD will collect data from the public and health care providers to support formative research, messages and materials development in birth defects and developmental disabilities, human development and disabilities, and blood disorders. 2016-09-30-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 155400 49650 0 2013-09-26-04:00

0920-0991 201308-0920-002 0920
             
        "Study to Explore Educational Children's Book in Pediatric Offices "
             
          
        
CDC's NCBDDD will conduct this study to assess the influence of the children's book, Amazing Me in pediatric office settings where the book will be distributed to parents of 3-year-old children, soon to be 3-year olds, and recently turned 4-year olds. The findings will help CDC determine if distribution of the book through RoR/pediatric office settings is an appropriate approach for delivering information about child development to parents and if children's literature is an appropriate approach for reaching parents and caregivers with health related messages. 2014-09-30-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 1968 229 0

Web Survey No Health Health Care Services
none Parent Survey Yes Yes Fillable Fileable Form Attachment 3a Amazing Me Parent Web Survey Screener and Survey Screenshots.pdf
Individuals or Households 900 150 0

Follow-up Web Survey No Health Health Care Services
none Follow-up Survey Yes Yes Fillable Fileable Form Attachment 4a Amazing Me Parent Follow-Up Contact Survey Screenshots.pdf
Individuals or Households 900 15 0

Focus Group Screener No Health Health Care Services
none Focus Group Screener No No Printable Only Form Attachment 5 Amazing Me Parent Focus Group Screener FINAL Feb 8 2013.docx
Individuals or Households 60 5 0

Focus Group Consent No Health Health Care Services
none Consent No No Printable Only Form and instruction Attachment 7 Informed Consent_Focus Group.docx
Individuals or Households 54 5 0

Focus Group Moderator's Guide No Health Health Care Services Individuals or Households 54 54 0

2013-09-26-04:00

0920-0992 201308-0920-003 0920
             
        "Impact Evaluation of CDC's Colorectal Cancer Control Program"
             
          
        
CDC plans to conduct a study to examine whether CRCCP program activities increase state-level colorectal cancer screening rates and other proximal outcomes. 2016-09-30-04:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 14456 2425 0

Screener for Population Survey No Health Illness Prevention
none Screener Yes Yes Fillable Fileable Form ATT 3 Screener for Colorectal Cancer Population Survey.docx
Individuals or Households 9600 800 0

Colorectal Cancer Population Survey No Health Illness Prevention
none Colorectal Cancer Population Survey Yes Yes Fillable Fileable Form ATT 4A Colorectal Cancer Population Survey_7.18.2013.docx
Individuals or Households 3200 1227 0

Screening Practices: Survey of Primary Care Providers No Health Illness Prevention
none Survey of Primary Care Providers No No Paper Only Form ATT 5A Colorectal Cancer Provider Survey_7.18.2013.doc
Private Sector 1600 320 0

Suggested Interviewees Form No Health Illness Prevention
none Site Visit Interviewee Form No No Printable Only Form ATT 6A Site Visit Suggested Interviewee Form.docx
State, Local, and Tribal Governments 4 4 0

Site Visit Instructions Template No Health Illness Prevention
none Site Visit InstructionTemplate No No Printable Only Form ATT 6B Site Visit Instruction Template 7.17.2013.docx
State, Local, and Tribal Governments 4 20 0

Interview Guide for Grantee Program Staff No Health Illness Prevention
none Att 7a - Grantee Program Staff Interview No No Printable Only Form ATT 7A Grantee Program Staff Interview Guide 7.18.2013.docx
State, Local, and Tribal Governments 12 15 0

Interview Guide for Grantee Evaluators No Health Illness Prevention
none Interview Guide for Grantee Evaluators No No Printable Only Form ATT 7B Grantee Evaluator Interview Guide 7.18.2013.docx
State, Local, and Tribal Governments 4 4 0

Interview Guide for Grantee Private Sector Partners No Health Illness Prevention
none Interview Guide for Grantee Partners No No Printable Only Form ATT 7C Grantee Partner Interview Guide 7.18.2013.docx
Private Sector 4 4 0

Interview Guide for Non-Grantee Private Sector Partners No Health Illness Prevention
none Interview with Nongrantee Partners No No Printable Only Form ATT 8C Non-Grantee Partner Interview Guide 7.18.2013.docx
Private Sector 4 4 0

Interview with Non-grantee Program Staff No Health Illness Prevention
none Interview Guide No No Printable Only Form ATT 8A Non-Grantee Program Staff Interview Guide 7.18.2013.docx
State, Local, and Tribal Governments 12 15 0

Interview with Non-grantee Evaluators No Health Illness Prevention
none Interview with Nongrantee Evaluators No No Printable Only Form ATT 8B Non-Grantee Evaluator Interview Guide 7.18.2013.docx
State, Local, and Tribal Governments 4 4 0

Interview with Nongrantee State and Local Partners No Health Illness Prevention
none Interview with Nongrantee Partners No No Printable Only Form ATT 8C Non-Grantee Partner Interview Guide 7.18.2013.docx
State, Local, and Tribal Governments 4 4 0

Interview with Grantee State and Local Partners No Health Illness Prevention
none Interview with Grantee Partners No No Printable Only Form ATT 7C Grantee Partner Interview Guide 7.18.2013.docx
State, Local, and Tribal Governments 4 4 0

2013-09-26-04:00

0920-0993 201308-0920-012 0920
             
        "Public Health Systems, Mental Health and Community Recovery Project"
             
          
        
This project stems from, and aligns with, publication of the Office of Public Health Preparedness and Response's (OPHPR) "National Strategic Plan for Public Health Preparedness and Response" which provides overall direction for Centers for Disease Control and Prevention's (CDC) preparedness and response portfolio, including programmatic direction across OPHPR's four divisions. The focus of this project is to generate findings useful for future preparedness planning and response in order to develop strategies and interventions aimed at mitigating the impact of adverse events. In April 2011, one of the largest tornado outbreaks ever recorded, a "Super Outbreak," occurred in the southeastern United States, resulting in more than 300 deaths and an estimated $11 million in damages. CDC, in collaboration with ICF International, will conduct a mixed method evaluation utilizing key informant interviews of public health and mental health agency staff and other community representatives at the local, county and State levels and household survey data in each of the communities to assess community recovery and resilience. Specifically, the study design includes two main components (qualitative and quantitative) designed to comprehensively examine the PH/MH system response to and community recovery and resilience from disasters. 2015-09-30-04:00 Active Petunia Gissendaner 4046390164 No No No 8790 1706 0

Key Informant Interview Guide_PH/MH Agency Staff No Disaster Management Disaster Repair and Restore
Yes No Printable Only Other Attachment C_ Key Informant Interview_ Introductory Letter.docx None Key Informant Interview Guide_Consent Form Yes No Printable Only Form and instruction Attachment G_Key Informant Interview Guide_Consent Form.docx Yes No Printable Only Other Attachment E_Key Informant Interview Guide_ PHMH Agency Staff.docx
State, Local, and Tribal Governments 53 53 0

Key Informant Interview Guide_Community Organization Respondents No Disaster Management Disaster Repair and Restore
Yes No Printable Only Other Attachment F_ Key Informant Interview Guide_ Community Organization Respondents.docx Yes No Printable Only Other Attachment C_ Key Informant Interview_ Introductory Letter.docx None Key Informant Interview Guide_Consent Form Yes No Printable Only Form and instruction Attachment G_Key Informant Interview Guide_Consent Form.docx
State, Local, and Tribal Governments 45 45 0

Household Survey (Telephone) for General Public and Consent No Disaster Management Disaster Repair and Restore
None Household Survey for General Public and Consent Yes No Printable Only Form and instruction Attachment D_ Household Survey for General Public and Consent.docx
Individuals or Households 3440 1433 0

Household Survey for General Public_Study Screener No Disaster Management Disaster Repair and Restore
None Household Survey for General Public_Study Screener Yes No Printable Only Form and instruction Attachment H_ Household Survey for General Public_ Study Screener.docx
Individuals or Households 5252 175 0

2013-09-30-04:00

0920-0994 201308-0920-004 0920
             
        "Pilot Project to Evaluate the Use of Exposure Control Plans for Bloodborne Pathogens in Private Dental Practices"
             
          
        
The Centers for Disease Control and Prevention estimate that healthcare workers sustain nearly 600,000 percutaneous injuries annually involving contaminated sharps. In response to both the continued concern over such exposures and the technological developments which can increase employee protection, Congress passed the Needlestick Safety and Prevention Act directing OSHA to revise the BBP Standard to establish requirements that employers identify and make use of effective and safer medical devices. That revision was published on Jan. 18, 2001, and became effective April 18, 2001. The revision to OSHA's BBP Standard added new requirements for employers, including additions to the exposure control plan and maintenance of a sharps injury log. The purpose of this pilot project al are to understand how bloodborne pathogens exposure control plans are implemented in private dental practices, an important segment of the non-hospital based healthcare system. The proposed work will draw on research-to-practice principles and will be assisted by a strong network of dental professional groups, trade associations, and government agencies. Specific objectives are to: inventory existing exposure control plans in private dental practices; determine whether the exposure control plan or other resource is actively used to prevent occupational exposures; determine available resources and barriers to use such as relevant educational materials, knowledge, costs, availability; and develop strategies to overcome key barriers to compliance. 2015-10-31-04:00 Active Thelma Sims 4046394771 No No No 20287 5072 0

BBP Exposure Control Plan Survery No Health Consumer Health and Safety Private Sector 20287 5072 0

2013-10-23-04:00

0920-0995 201309-0920-002 0920
             
        "Health Professional Application for Training (HPAT)"
             
          
        
This ICR includes the Health Professional Application for Training (HPAT) which is used to monitor and evaluate performance of grantees funded by CDC/Division of STD Prevention (DSTDP) and Division of HIV/AIDS Prevention (DHAP) that offer STD and HIV prevention training, training assistance, and capacity building assistance to health professionals (physicians, nurses, disease intervention specialists, health educators, etc.). The HPAT collects information from training participants on their 1) occupations, professions, and functional roles; 2) principal employment settings; 3) location of their work settings; and 4) programmatic and population foci of their work. The data collection is necessary to assess the performance of the grantees in delivering training to health care providers and to standardize training registration processes across the two training programs (e.g., the PTC program and the CBA provider program) and multiple grantees funded by each program. The data collection instrument also allows CDC grantees to use a single instrument when partnering with other HHS funded training programs. This data collection provides CDC with information to determine whether the training grantees are reaching their target audiences in terms of provider type, the types of organizations in which participants work, the focus of their work and the population groups and geographic areas served; the data collection is also used to triage and assign CBA provider requests. 2016-10-31-04:00 Active Thelma Sims 4046394771 No No No 7400 617 0

Health Professional Applicaton for Traiing (HPAT) No Health Consumer Health and Safety Individuals or Households 7400 617 0

2013-10-30-04:00

0920-0996 201309-0920-009 0920
             
        ""So What? Telling a Compelling Story" Template"
             
          
        
The storytelling template is a single page, double-sided guide for public health preparedness storytellers, or "sources", to provide a story "lead" including a headline and three bullet points for potential follow up at a later date. The intent of this worksheet is to guide the development of bullets and headlines describing successes, impacts, and other funding-related activities for public health preparedness and response. 2016-10-31-04:00 Active Thelma Sims 4046394771 No No No 130 95 0

SO WHAT? Telling a Compelling Story...Activity Template No Health Immunization Management State, Local, and Tribal Governments 100 50 0

"So What? Telling a Compelling Story" Follow-up Questions No Health Immunization Management State, Local, and Tribal Governments 30 45 0

2013-10-30-04:00

0920-0997 201310-0920-007 0920
             
        "Standardized National Hypothesis Generating Questionnaire"
             
          
        
The goal of this project is to define a core set of data elements to be used for hypothesis generation during multistate foodborne investigations. 2016-10-31-04:00 Active Petunia Gissendaner 4046390164 No No No 4000 3000 0

Hypothesis Generating Questionnaire for PulseNet Cluster Code No Health Immunization Management
No form number Hypothesis Generating Questionnaire for PulseNet Cluster Code Yes No Paper Only Form AttachmentC_SNHGQ questionnaire.pdf
Individuals or Households 4000 3000 0

2013-10-31-04:00

0920-0998 201311-0920-003 0920
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery  "
             
          
        
This collection of information is necessary to enable the Agency to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the Agency's programs. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. 2016-11-30-05:00 Active Petunia Gissendaner 4046390164 No No No 3300 1650 0 2013-11-06-05:00

0920-0999 201308-0920-011 0920
             
        "Determining Causes of Sudden, Unexpected Infant Death: A National Survey of U.S. Medical Examiners and Coroners"
             
          
        
CDC plans to conduct a mail survey of medical examiners and coroners to describe knowledge, opinions, diagnostic and reporting practices relating to sudden unexpected infant deaths. 2014-11-30-05:00 Active Thelma Sims 4046394771 No No No 1440 387 0

National Survey of Medical Examiners No Health Immunization Management Private Sector 576 288 0

National Survey of Coroners No Health Immunization Management Private Sector 64 32 0

Screener No Health Immunization Management Private Sector 800 67 0

2013-11-08-05:00

0920-1000 201401-0920-010 0920
             
        "Image-Assisted Cytology Workload Assessment and Measure"
             
          
        
The primary change request is to reformat the survey instrument forms to deliver the survey via Survey Monkey as a single online survey, rather than two paper surveys to be delivered by mail. There are corresponding changes in the format of the survey due to change in the delivery mode. The reason for the request to change to an online delivery format is to increase the efficiency of completing the survey. The online format also allows for skip logic patterns to be included in the survey which will assure that respondents are not asked questions that are not applicable based on their previous responses; this will be a benefit to respondents in reducing response errors. 2014-12-31-05:00 Active Thelma Sims 4046394771 No No No 5577 2789 0

Image-Assisted Cytology Workload Practices Survey--Laboratory No Health Health Care Services Private Sector 996 498 0

Image-Assisted Cytology Workload Assessment Survey--Cytotechnologists No Health Health Care Services Private Sector 4581 2291 0

2014-02-03-05:00

0920-1001 201311-0920-009 0920
             
        "World Trade Center Enrollment & Appeals - Pentagon & Shanksville"
             
          
        
Title XXXIII of the Public Health Safety Act establishes the World Trade Center (WTC) Health Program within the Department of Health and Human Services. This program provides medical monitoring and treatment benefits to responders to the September 11, 2001 terrorist attacks in New York City, at the Pentagon, and in Shanksville, PA, and to survivors of the terriorist attacks in New York City. 2016-12-31-05:00 Active Carol Marsh cww6@cdc.gov 404 639-4773 No No No 2685 831 0

Responder Eligibility Application No Health Health Care Services
none Eligibility Application Yes No Printable Only Form and instruction Appendix H.docx
Individuals or Households 1605 803 0

Responder Appeals to Eligibility Denial No Health Health Care Services Individuals or Households 4 2 0

Responder Appeals Certification of Health Conditions No Health Health Care Services Individuals or Households 1 1 0

Responder Appeals Treatment No Health Health Care Services Individuals or Households 14 7 0

Pharmacies Outpatient Prescription Pharmaceuticals No Health Health Care Services Individuals or Households 1060 18 0

Responder Travel Refund Request No Health Health Care Services
none Travel Refund Request No No Printable Only Form Appendix D - Travel Refund Request.docx
Individuals or Households 1 0 0

2013-12-13-05:00

0920-1002 201311-0920-005 0920
             
        "Assessment of a Comprehensive HIV Clinic-based Intervention to Improve Patients' Health and Reduce Transmission Risk"
             
          
        
The purpose of this project is to increase the percentage of HIV patients who (1) have an undetectable viral load, (2) adhere optimally to antiretroviral therapy (ART), (3) attend clinic regularly for primary care, and (4) practice safer sex. These are objectives of the National HIV/AIDS Strategy and goals of the strategic plan of the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention. The project will be conducted at six HIV clinics in the United States with the following institutions: (1) Baylor College of Medicine, Houston, (2) Boston Medical Center, (3) University of Alabama, Birmingham, (4) University of California at San Diego, (5) University of Miami Medical School, and (6) University of Washington in the state of Washington. The intervention focuses primary on HIV patients who have a detectable viral load, i.e., their viral load is not as low as it can be and is not fully controlled. The intervention includes: (1) brief counseling from medical providers during primary care visits informed by a behavioral screener completed by patients; (2) a computer-based intervention (CBI) in which patients see short audio/visual about the importance of regular clinic attendance, adherence to ART, and safer sex; and (3) opportunity for one-on-one counseling from a prevention specialist if needed. 2016-12-31-05:00 Active Petunia Gissendaner 4046390164 No No No 33171 3378 11667

Electronic Transmittal of Clinical Variables Archived in Clinic Databases--Data Manager/no form No Health Consumer Health and Safety Individuals or Households 24 576 11667

Patient Behavior Screener (for English, Spanish & Creole) No Health Consumer Health and Safety
None Appendix 6: Patient Behavior Screener (Creole) Yes No Paper Only Form and instruction App 6 Patient beh screener (Creole).docx None Appendix 4: Patient Behavior Screener (English) Yes No Paper Only Form and instruction App 4 Patient beh screener (English).docx None Appendix 5: Patient Behavior Screener (Spanish) Yes No Paper Only Form and instruction App 5 Patient beh screener (Spanish).docx
Individuals or Households 25260 2105 0

Computer-Based Intervention Assessment Items (English&Spanish) No Health Consumer Health and Safety
None Appendix 7: Computer-Based Intervention Assessment Items (English) Yes Yes Fillable Fileable Form and instruction App 7 CBI Items (English).docx None Appendix 8: Computer-Based Intervention Assessment Items (Spanish) Yes Yes Fillable Fileable Form and instruction App 8 CBI Items (Spanish).docx
Individuals or Households 6207 517 0

Patient Exit Survey (English, Spanish & Creole) No Health Consumer Health and Safety
None Appendix 10: Patient Exit Survey (Spanish) Yes Yes Fillable Fileable Form and instruction App 10 Patient Exit Survey (Spanish).docx None Appendix 9: Patient Exit Survey (English) Yes Yes Fillable Fileable Form and instruction App 9 Patient Exit Survey (English).docx None Appendix 11: Patient Exit Survey (Creole) Yes Yes Fillable Fileable Form and instruction App 11 Patient Exit Survey (Creole).docx
Individuals or Households 1200 100 0

Provider Survey (English Only) No Health Consumer Health and Safety
None Appendix 12: Provider Survey (English Only) Yes Yes Fillable Fileable Form and instruction App 12 Provider Survey.docx
Individuals or Households 480 80 0

2013-12-13-05:00

0920-1003 201311-0920-012 0920
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (OADC)"
             
          
        
This collection of information is necessary to enable the Agency to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the Agency's programs. 2016-12-31-05:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 180000 12000 0 2013-12-26-05:00

0920-1004 201309-0920-011 0920
             
        "Adoption, Health Impact and Cost of Smoke-Free Multi-Unit Housing Policies"
             
          
        
CDC plans to conduct a series of projects designed to explore the potential impacts of smoke-free policies in multi-unit residential housing facilities One project is a quasi-experimental pretest, posttest design study with an intervention group and a comparison group to explore changes in behavior and exposure among residents in Los Angeles. This quasi-experimental study is not des igned to detect changes in residents' health. Other study components include surveys of multi-unit housing (MUH) operators and residents, objective measures of air quality and tobacco exposure, and focus groups with residents in three states with different policies. 2016-12-31-05:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No Yes No 4664 1922 0

Phone script for Recruitment of MUH operators in LA No Health Immunization Management
none Recruitment Script LA Yes Yes Fillable Fileable Form Att 4A(e) MUH Operator Recruitment Script LA_9.3.13.docx
Private Sector 173 14 0

MUH Operator Baseline Survey (LA County) No Health Immunization Management
none MUH Operator Baseline Survey No No Fillable Printable Form clean 12.17.13 Att 6A(e) Baseline Operator Survey_9.3.13.doc
Private Sector 130 163 0

MUH Operator Baseline Survey - MN, ME, FL No Health Immunization Management
none MUH Operator Baseline Survey - MN, ME, FL Yes No Fillable Printable Form clean 12.17.13 Att 6A(e) Baseline Operator Survey_9.3.13.doc
Private Sector 6 8 0

Phone script for recruitment of MUH operators - MN, ME, FL No Health Immunization Management
none Recruitment phone script MN, ME, FL Yes Yes Fillable Fileable Form and instruction Att 5A(e) MUH Operator Recruitment Script MNMEFL_9.3.13.docx
Private Sector 6 1 0

MUH Operator Post-intervention Survey - LA county No Health Immunization Management
none 7A - MUH operator post-intervention survey - LA county Yes No Fillable Printable Form clean 12.17.16 Att 7A(e)_Post-Intervention Operator Survey.doc
Private Sector 130 163 0

MUH operators post-intervention survey - MN, ME, FL No Health Immunization Management
none MUH Operator Post Intervention Survey - LA, ME, MN, FL Yes No Fillable Printable Form clean 12.17.16 Att 7A(e)_Post-Intervention Operator Survey.doc
Private Sector 6 8 0

MUH Resident Baseline Survey - screening LA No Health Immunization Management
none MUH Resident Survey - LA (English) Yes No Fillable Printable Form clean 12.17.13Att 8A(e)_MUH Resident Baseline Survey.doc none MUH Resident Survey - LA (Spanish) Yes No Fillable Printable Form clean 12.17.13 Att 8A(s)_MUH Resident Baseline Survey_12.15.13.doc
Individuals or Households 833 69 0

MUH Resident Baseline Survey - Core LA No Health Immunization Management
none MUH Resident Baseline - Core - sections A-F Spanish Yes No Fillable Printable Form clean 12.17.13 Att 8A(s)_MUH Resident Baseline Survey_12.15.13.doc none MUH Resident Baseline - Core - sections A-F Yes No Fillable Printable Form clean 12.17.13Att 8A(e)_MUH Resident Baseline Survey.doc
Individuals or Households 500 375 0

MUH Resident Baseline Survey - Children's Module LA No Health Immunization Management
none MUH Resident Baseline - Children's Module section G Spanish Yes No Fillable Printable Form clean 12.17.13 Att 8A(s)_MUH Resident Baseline Survey_12.15.13.doc none MUH Resident Baseline - Children's Module section G Yes No Fillable Printable Form clean 12.17.13Att 8A(e)_MUH Resident Baseline Survey.doc
Individuals or Households 250 63 0

MUH Resident Post-intervention Survey - Core LA No Health Immunization Management
none Resident Surevy Post-intervention Spanish Yes No Fillable Printable Form clean 12.17.13 Att 9A(s)_MUH Resident Baseline Survey_12.15.13.doc none Resident Survey - Post-intervention Yes No Fillable Printable Form clean 12.17.13Att 9A(e)_MUH Resident Baseline Survey.doc
Individuals or Households 500 375 0

MUH Resident Post-intervention Children's Module - LA No Health Immunization Management
none Resident Survey Post-int - children's module section G Spanish Yes No Fillable Printable Form clean 12.17.13 Att 9A(s)_MUH Resident Baseline Survey_12.15.13.doc none Resident Survey Post-int- children's module section G Yes No Fillable Printable Form clean 12.17.13Att 9A(e)_MUH Resident Baseline Survey.doc
Individuals or Households 250 63 0

MUH Resident Saliva Collection No Health Immunization Management
none Saliva Collection No No Printable Only Form and instruction Att 10A(e) Protocol for Saliva Collection 8 29 2012.docx
Individuals or Households 1000 167 0

MUH Resident Air Quality Monitoring No Health Immunization Management Individuals or Households 200 300 0

MUH Saliva Collection - children No Health Immunization Management Individuals or Households 500 83 0

Resident Focus Group Screening No Health Immunization Management
none Focus Group Screener No No Printable Only Form Att 12A_Focus Group Screening Script.docx
Individuals or Households 60 5 0

Resident Pre-Focus Group Survey No Health Immunization Management
none Resident Pre-Focus Group Survey Yes No Fillable Printable Form Att 13A_Resident Pre-Focus Group Survey_9.3.13.docx
Individuals or Households 60 5 0

Resident Focus Group Guide - Process Oriented No Health Immunization Management
none Focus Group Guide No No Printable Only Form Att 13B_Focus Group - Process Oriented_9 20 2012.docx
Individuals or Households 30 30 0

Resident Focus Group Guide - Outcome Oriented No Health Immunization Management Individuals or Households 30 30 0

2013-12-27-05:00

0920-1005 201311-0920-013 0920
             
        "Older Adult Safe Mobility Assessment Tool"
             
          
        
The Older Adult Safe Mobility Assessment Tool project involves developing, refining and validating a Safe Mobility Assessment Tool that allows older adults to assess their current mobility situation, learn about mobility challenges that may affect them in the future, and receive actionable feedback on how to improve and protect their mobility. The information collected in this project will be used to refine and improve the Tool, as well as to conduct feasibility and audience acceptability analysis of the Tool. This information will allow CDC to create the most useful Safe Mobility Assessment Tool possible for U.S. older adults. 2014-12-31-05:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 2114 765 0

Key Informant Consent and Interview Guide No Health Health Care Services Individuals or Households 6 3 0

Focus Group Consent & Screener No Health Health Care Services Individuals or Households 14 4 0

Intercept Consent and Screener No Health Health Care Services Individuals or Households 40 10 0

Telephone Survey Consent and Screener No Health Health Care Services Individuals or Households 1000 250 0

Focus Group Moderator Guide No Health Health Care Services Individuals or Households 14 28 0

Intercept Interview Guide No Health Health Care Services Individuals or Households 40 20 0

Telephone Survey No Health Health Care Services Individuals or Households 1000 450 0

2013-12-30-05:00

0920-1006 201312-0920-004 0920
             
        "CDC Work@Health Program:  Phase 2 Training and Technical Assistance Evaluation"
             
          
        
This is a new ICR. CDC plans to implement and evaluate a comprehensive workplace health training program called Work@Health. Information will be collected from employers, employees, and trainers. 2016-01-31-05:00 Active Thelma Sims 4046394771 No Yes No 5066 1601 0

CDC Work@Health Employer Application Form No Health Immunization Management State, Local, and Tribal Governments 600 200 0

CDC Worksite Health Scorecard No Health Immunization Management State, Local, and Tribal Governments 540 270 0

CDC Work Health Organizational Assessment No Health Immunization Management State, Local, and Tribal Governments 540 135 0

CDC Work@Health Employer Follow-up Survey No Health Immunization Management State, Local, and Tribal Governments 270 68 0

CDC Work@Health Case Study Interviews with Senior Leadership No Health Immunization Management State, Local, and Tribal Governments 3 3 0

CDC Work@Health Case Study Interviews with Employees No Health Immunization Management State, Local, and Tribal Governments 6 6 0

CDC Work@ Health Trainee KAB Survey No Health Immunization Management State, Local, and Tribal Governments 1080 360 0

CDC Work@Health Trainee Reaction Survey Hands-On Model No Health Immunization Management State, Local, and Tribal Governments 180 45 0

CDC Work@Health Trainee Reaction Survey Online Model No Health Immunization Management State, Local, and Tribal Governments 180 45 0

CDC Work@Health Trainee Reaction Survey Blended Model No Health Immunization Management State, Local, and Tribal Governments 180 45 0

CDC Work@Health Trainee Technical Assistance Survey No Health Immunization Management State, Local, and Tribal Governments 1080 270 0

CDC Work @Health Case Study Interviews with Selected Trainees No Health Immunization Management State, Local, and Tribal Governments 15 15 0

CDC Work@Health Trainee Focus Group Discussion Guide No Health Immunization Management State, Local, and Tribal Governments 11 17 0

CDC Work@Health Train-the-Trainer Application Form No Health Immunization Management State, Local, and Tribal Governments 60 30 0

CDC Work@Health Train-the-Trainer Participant Survey No Health Immunization Management State, Local, and Tribal Governments 60 20 0

CDC Work @Health Train-the-Trainer Reaction Survey No Health Immunization Management State, Local, and Tribal Governments 30 8 0

CDC Word@Health Train-the Trainer Trainee Technical Assistance Survey No Health Immunization Management State, Local, and Tribal Governments 60 15 0

CDC Work@Health Wave 2 Trainee Reaction Survey No Health Immunization Management State, Local, and Tribal Governments 150 38 0

CDC Work@Health Instructor/Coach Group Discussion Guide No Health Immunization Management State, Local, and Tribal Governments 21 11 0

2014-01-02-05:00

0920-1007 201312-0920-003 0920
             
        "National Survey of Community-based Policy and Environmental Supports for Healthy Eating and Active Living"
             
          
        
CDC plans to conduct a survey to assess local governments' policies and practices that support health eating and active living among their residents. 2015-01-31-05:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 25559 3438 0

Survey No Health Immunization Management
none Survey - Word No No Printable Only Form Appendix C1 CBS National Survey_Questionaire_Revised 120313.docx none Survey - screenshots Yes Yes Fillable Fileable Form Appendix C2 Screenshots of Survey Questionnaire_Revised _120313..pdf
State, Local, and Tribal Governments 3139 1570 0

Telephone Follow-up No Health Immunization Management
none Non-response Follow-up Yes Yes Fillable Fileable Form Appendix D4 Non Response Follow Up_12032013.doc
State, Local, and Tribal Governments 22420 1868 0

2014-01-02-05:00

0920-1008 201311-0920-010 0920
             
        "Evaluation of the SAMHSA PDMP Electronic Health Record Integration and Interoperability Expansion Program"
             
          
        
CDC proposes a qualitative evaluation of the Prescription Drug Monitoring Program (PDMP) Electronic Health Record (EHR) Integration and Interoperability Expansion (PEHRIIE) program. The program is a collection of state initiatives funded by 2012 Prevention and Public Health Funds cooperative agreements through DHHS, SAMHSA. CDC is conducting an evaluation of the program to understand the processes, challenges, and successes in implementing and sustaining integration of PDMP data with Health Information Technology systems and interoperability of PDMP systems across states. The collection will capture the experiences of clinical end users with the systems being upgraded under the PEHRIIE program and their recommendations for how the goals of the PEHRIIE program could have been better accomplished. 2016-01-31-05:00 Active Shari Steinberg sxw2@cdc.gov 404 639-4942 No No No 132 119 0

Interview Guide for Key Project Staff and Stakeholders No Health Consumer Health and Safety
none Interview Guide No No Printable Only Form and instruction Attachment 3 - Key Project Staff and Stakeholders Interview Guide - Final.docx
Individuals or Households 53 40 0

Interview Guide for End Users No Health Consumer Health and Safety
none Interview Guide No No Printable Only Form and instruction Attachment 4 - Clinical End Users Interview Guide - Final.docx
Individuals or Households 59 59 0

Clinical End Users Recruiters No Health Consumer Health and Safety Individuals or Households 20 20 0

2014-01-15-05:00

0923-0041 201305-0923-004 0923
             
        "National Amyotrophic Lateral Sclerosis  (ALS) Registry"
             
          
        
The Agency for Toxic Substances and Disease Registry (ATSDR) requests clearance for continuation of use of the National Amyotrophic Lateral Sclerosis (ALS) Registry. ALS is a complex neurodegenerative disease of unknown etiology, but believed to be the result of a combination of genetic and environmental factors. The revision includes the addition of voluntary risk factor surveys. 2016-09-30-04:00 Active Shari Steinberg shari.steinberg@cdc.hhs.gov 404 639-4942 No No No 16895 1375 0

ALS Validation Questions No Health Immunization Management
none ALS Registry Validation Questions Yes Yes Fillable Fileable Form Attach_4-Screen Shots Validation Questions.docx
Individuals or Households 1670 56 0

ALS Registration No Health Immunization Management
none ALS Registry Registration Yes Yes Fillable Fileable Form Attach_5-Screen Shot Registration Page.docx
Individuals or Households 1500 175 0

ALS One-time Survey No Health Immunization Management
none 6b - New Surveys Yes Yes Fillable Fileable Form Attach_6b-Screen Shots New Surveys-V2.docx none 6a - Previously approved surveys Yes Yes Fillable Fileable Form Attach_6a-Screen Shots_Previously Approved Surveys-v2.docx
Individuals or Households 12000 1000 0

ALS Twice Yearly Survey No Health Immunization Management
none 6b - New surveys Yes Yes Fillable Fileable Form Attach_6b-Screen Shots New Surveys-V2.docx none 6a - Previously approved surveys Yes Yes Fillable Fileable Form Attach_6a-Screen Shots_Previously Approved Surveys-v2.docx
Individuals or Households 1725 144 0

2013-09-12-04:00

0923-0043 201206-0923-001 0923
             
        "Creation of State and Metropolitan Area Based Surveillance Projects for Amyotrophic Lateral Sclerosis (ALS)"
             
          
        
This nonsubstantive change request is to notify OMB of the three additional sites that were selected for this project, as per terms of clearance. 2014-04-30-04:00 Active Petunia Gissendaner 4046390164 No No No 3186 703 0

ALS Case Reporting Form No Health Public Health Monitoring
none Case Reporting Form No No Printable Only Form Attachment 3 -case report form for training-3-31-11-final.docx
Private Sector 2250 188 0

ALS Medical Record Verification Form No Health Public Health Monitoring
none Medical Record Verification Form No No Printable Only Form Attachment 4 Medical Record Verification Form (2).docx
Private Sector 450 150 0

Training for Reporting No Health Public Health Monitoring Private Sector 243 122 0

Line Listing No Health Public Health Monitoring Private Sector 243 243 0

2012-07-23-04:00

0923-0044 201309-0923-001 0923
             
        "Biomonitoring of Great Lakes Populations Program "
             
          
        
In 2009, the federal Great Lakes Restoration Initiative (GLRI) was established under the stewardship of the U.S. Environmental Protection Agency (US EPA) to protect, restore, and maintain the Great Lakes ecosystem in partnership with 15 other federal agencies. The task force of federal agencies developed the GLRI Action Plan which covers fiscal years 2010 to 2014. In the first 2 years the U.S. EPA has received over three quarters of a billion dollars through the Obama administration's stimulus funding to make substantial progress towards restoring the Great Lakes to ecological health. Under an interagency agreement with the US EPA, the Agency for Toxic Substances and Disease Registry (ATSDR) established the Great Lakes Biomonitoring Program under its 1980 Comprehensive Environmental Response Compensation and Liability Act (CERCLA) authority. The ATSDR Great Lakes Biomonitoring Program aims to provide a human exposure assessment to Great Lakes contaminants among targeted subpopulations concurrent with the onset of restoration activities. The Agency for Toxic Substances and Disease Registry (ATSDR) announced a funding opportunity called the "Biomonitoring of Great Lakes Populations Program" (CDC-RFA-TS10-1001). From the applicants for this cooperative agreement, ATSDR awarded funds to the Michigan Department of Community Health (MDCH), the Minnesota Department of Health (MDH), and the New York State Department of Health (NYS DOH) to conduct non-research studies of human exposures and to advance jurisdiction-specific public health actions. This public health effort focuses on vulnerable or susceptible subpopulations with the potential for increased risk of exposure to persistent contaminants common to the Great Lakes watersheds and ecosystems. 2015-10-31-04:00 Active Carol Marsh cww6@cdc.gov 404 639-4773 No No No 7906 1000 0

MI Screener No Health Immunization Management
none MI screener No No Paper Only Form Att4a_MI_ScreenQs_2.15.12.doc
Individuals or Households 2000 167 0

MI Scheduling Questionnaire No Health Immunization Management
none MI Scheduling Questionnaire No No Paper Only Form Att4b_MI_PhoneQs 20120712.doc
Individuals or Households 250 29 0

MI Informed Consent No Health Immunization Management
none MI Consent No No Paper Only Form Att4c_MI_Consent 20120712.doc
Individuals or Households 200 3 0

MI Biomonitoring Questionnaire No Health Immunization Management
none MI Biomonitoring Questionnaire Yes Yes Fillable Fileable Form Att4e_MI_BiomQs_20120619.doc
Individuals or Households 200 173 0

MN Recruitment Script No Health Immunization Management
none MN Recruitment Script Yes Yes Fillable Fileable Form Att5a_MN_RcrtmtCallScrpt_20120712.docx
Individuals or Households 396 33 0

MN Refusal Questions No Health Immunization Management
none MN Refusal Questions Yes Yes Fillable Fileable Form Att5b_MN_RefusalQs_20120131.docx
Individuals or Households 107 4 0

MN Consent No Health Immunization Management
none MN Consent No No Paper Only Form Att5c_MN_Consent_20120712.docx
Individuals or Households 250 13 0

MN Contact Information No Health Immunization Management
none MN Contact Information No No Paper Only Form Att5d_MN_ContactInfo_20120112.docm
Individuals or Households 250 8 0

MN Participant Questionnaire No Health Immunization Management
none MN Participant Questionnaire Yes Yes Fillable Fileable Form Att5e_MN_StdyPartQs_20120619.doc
Individuals or Households 250 125 0

MN Clinic Visit Form No Health Immunization Management
none MN Clinic Visit No No Paper Only Form Att5f_MN_ClncVstForm_20120131.docx
Individuals or Households 250 4 0

MN Participation Record No Health Immunization Management
none MN Participation Record No No Paper Only Form Att5g_MN_PrtcptRcrd_20120712.docx
Individuals or Households 250 4 0

NY Mail-in Screener No Health Immunization Management
none NY Mail-in Screener No No Paper Only Form Att6b_NY_MailScreen_LA_20120619.docx
Individuals or Households 518 43 0

NY Online Screener No Health Immunization Management
none NY Online Screener Yes Yes Fillable Fileable Form Att6c_NY_OnlnScreen_LA_20120619.docx
Individuals or Households 778 65 0

NY Nonresponder Script No Health Immunization Management
none NY Nonresponder Script No No Paper Only Form Att6d_NY_PhnScrpt_NR_LA_20120619.docx
Individuals or Households 864 72 0

NY Responder Script No Health Immunization Management
none NY Responder Script No No Paper Only Form Att6e_NY_PhnScrpt_R_LA_20120619.docx
Individuals or Households 259 22 0

NY Consent No Health Immunization Management
none NY Consent No No Paper Only Form Att6f_NY_Consent_LA_20120712.docx
Individuals or Households 200 3 0

NY Questionnaire No Health Immunization Management
none NY Questionnaire Yes Yes Fillable Fileable Form Att6g_NY_IntrvwQs_LA_20120619.docx
Individuals or Households 200 100 0

NY Screener - Burmese No Health Immunization Management
none NY Screener - Burmese No No Paper Only Form Att6h_NY_ScrnSrvy_Brms_20120619.docx none Screener - Burmese translation No No Paper Only Form Att6h_NY_ScrnSrvy_Brms_20120619 (Burmese Translation).pdf
Individuals or Households 184 15 0

NY Consent - Burmese No Health Immunization Management
none NY Consent - Burmese translation No No Paper Only Form Att6i_NY_Consent_Brms_20120712(Burmese Translation).pdf none NY Consent - Burmese No No Paper Only Form Att6i_NY_Consent_Brms_20120712.docx
Individuals or Households 100 2 0

NY Interview - Burmese No Health Immunization Management
none Interview - Burmese translation No No Paper Only Form Att6j_NY_IntrvwQs_Brms_20120619 (Burmese Translation).pdf none NY Interview - Burmese Yes Yes Fillable Fileable Form Att6j_NY_IntrvwQs_Brms_20120619.docx
Individuals or Households 100 100 0

NY - Network Questions - Burmese No Health Immunization Management
none NY Network Questions - Burmese No No Paper Only Form Att6k_NY_NtwrkQs_Brms_20120619.docx none Network Questions - Burmese translation No No Paper Only Form Att6k_NY_NtwrkQs_Brms_20120619 (Burmese Translation).pdf
Individuals or Households 100 8 0

MI Contact Information Sheet No Health Immunization Management
none MI Contact Info Sheet No No Paper Only Form Att4d_MI_Contact_20120619.docx
Individuals or Households 200 7 0

2013-10-17-04:00

0923-0045 201211-0923-001 0923
             
        "Registration of Individuals Displaced by Hurricanes Katrina and Rita (Pilot Project)"
             
          
        
In 2005, Hurricanes Katrina and Rita struck the Gulf Coast. In the aftermath, an estimated 375,000 persons occupied temporary housing units supplied by FEMA. Persons living in these units may have been exposed to high levels of formaldehyde. We propose to develop a pilot registry called the Katrina and Rita Exposure (KARE) Registry that will serve as a starting point to see if a full registry is feasible due to the time that has passed between the hurricanes and data collection (7 years). This pilot registry will consist of people who occupied FEMA supplied temporary housing after Hurricanes Katrina and Rita. CATI technology will be used to collect the data. 2016-02-29-05:00 Active Shari Steinberg shari.steinberg@cdc.hhs.gov 404 639-4942 No No No 4000 533 0

Screener No Health Immunization Management
none Screener Yes Yes Fillable Fileable Form and instruction Appendix E Screener 20130125.doc none Screener Yes Yes Fillable Fileable Form and instruction
Individuals or Households 2500 83 0

Katrina and Rita Exposures Registry - questionnaire No Health Immunization Management
none Quesitonaire Yes Yes Fillable Fileable Form and instruction Appendix F Main Questionnaire 20130130.doc
Individuals or Households 1500 450 0

2013-02-08-05:00

0923-0046 201305-0923-005 0923
             
        "Prospective Birth Cohort Study Involving Environmental Uranium Exposure in the Navajo Nation"
             
          
        
This is a request to change the developer of the survey instruments due to system changes. 2016-02-29-05:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 7400 4455 0

Enrollment Survey - mother No Health Immunization Management
none Enrollment Survey for Mothers No No Printable Only Form Attach 3a Mother Enroll 2-6-13.docx
Individuals or Households 550 1100 0

Enrollment Survey - father No Health Immunization Management
none Enrollment Survey for Fathers No No Printable Only Form Attach 3b Father Enroll 2-6-13.docx
Individuals or Households 550 825 0

Ages and Stages Questionnaire No Health Immunization Management
none Ages and Stages Questionnaires Inventory No No Printable Only Form Attach 3c Ages Stages 2-6-13.docx
Individuals or Households 2000 500 0

Mullen Stages of Early Development No Health Immunization Management
none Mullen Scales of Early Learning Record Form No No Printable Only Form Attach 3d Mullen 2-6-13.docx
Individuals or Households 500 167 0

Food Frequency Questionnaire No Health Immunization Management
none Food Frequency Questionnaire No No Printable Only Form Attach 3g FoodFreq WIC 2-6-13.docx
Individuals or Households 500 375 0

Postpartum Survey - 2 months No Health Immunization Management
none Postpartum Survey for Mothers No No Printable Only Form Attach 3e Postpart 2Mo 2-6-13.docx
Individuals or Households 500 500 0

Postpartum Survey - 6, 9, 12 months No Health Immunization Management
none Postpartum Survey for Mothers: 6, 9, and 12 months No No Printable Only Form Attach 3f Postpart 6 9 12Mo 2-6-13.docx
Individuals or Households 1500 375 0

Eligibility Screener No Health Immunization Management
none Eligibility Screener No No Printable Only Form Attach 3h Eligibility 2-6-13.docx
Individuals or Households 750 63 0

Home Environmental Assessment No Health Immunization Management
none Home Environmental Assessment No No Printable Only Form and instruction Attach 17 Home Env Assmnt Protocol 2-6-13.docx
Individuals or Households 550 550 0

2013-05-31-04:00

0923-0047 201305-0923-003 0923
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery"
             
          
        
The collection of information is necessary to enable the Agency to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the Agency's programs. 2016-05-31-04:00 Active Shari Steinberg shari.steinberg@cdc.hhs.gov 404 639-4942 No No No 8400 7275 0

ATSDR Customer Satisfaction Survey for DCHI Documents No Environmental Management Pollution Prevention and Control
None ATSDR Customer Satisfaction Survey for DCHI Documents (on-line) Yes Yes Fillable Fileable Form AttB. ATSDR Customer Satisfaction Survey for DCHI Documents (on-line).docx None ATSDR Customer Satisfaction Survey for DCHI Documents (on-line) Yes Yes Fillable Fileable Form AttC. ATSDR Customer Satisfaction Survey for DCHI Documents (text).docx
State, Local, and Tribal Governments 1000 83 0

2013-05-16-04:00

0923-0048 201401-0923-001 0923
             
        "ATSDR Exposure Investigations (EIs)"
             
          
        
This is a request to add respondents and burden hours to this generic collection due to an error by CDC ICRO when the ICR was initially submitted and only one year of burden was requested. 2016-05-31-04:00 Active Shari Steinberg shari.steinberg@cdc.hhs.gov 404 639-4942 No No No 3600 1800 0

Colorado Smelter Exposure Investigation No Environmental Management Pollution Prevention and Control
none Colorado Smelter Questionnaire Yes Yes Fillable Fileable Form Att4_Pueblo Colorado Smelter EI Questnnre 8_5_2013.docx
Individuals or Households 300 100 0

2014-02-05-05:00

0923-0049 201312-0923-001 0923
             
        "Anniston Community Health Survey:  Follow up and Dioxin Analyses (ACHS-II)"
             
          
        
The Agency for Toxic Substances and Disease Registry (ATSDR) funded the 2005-2007 Anniston Community Health Survey (ACHS) and found serum PCB levels among Anniston participants three-to-seven-fold higher than among the general U.S. population. PCBs were also positively associated with hypertension, elevated blood pressure, and diabetes in select cohort subgroups. Researchers from ATSDR and National Institutes of Health (NIH) plan to conduct a follow-up to the original ACHS, called the ACHS-II. For this follow-up study, a sample of 500 participants will be enrolled from the original ACHS cohort. The major goal of the ACHS-II is to obtain repeated measures of PCBs and health outcomes, five to seven years after baseline, identical to the original ACHS and to complement those with the measurements of dioxin-like coplanar PCB congeners, dibenzo-p-dioxins and furans, polybrominated diphenyl ethers and heavy metals not measured before in this population. 2015-11-30-05:00 Active Tony Richardson lmr7@cdc.gov 404 639-4965 No No No 1493 226 0

Recruitement Telephone Script No Health Immunization Management Individuals or Households 333 11 0

Survey for Refusals No Health Immunization Management Individuals or Households 160 3 0

Update Contact information Form No Health Immunization Management Individuals or Households 250 4 0

Medication Form No Health Immunization Management Individuals or Households 250 12 0

Blood Draw Form No Health Immunization Management Individuals or Households 250 8 0

Questionnaire Materials No Health Immunization Management Individuals or Households 250 188 0

2013-12-12-05:00

0925-0001 201306-0925-004 0925
             
        "PHS Applications and Pre-award Related Reporting (OD)"
             
          
        
The National Institutes of Health (NIH) and other Public Health Service (PHS) agencies currently use the Research and Research Training Grant Applications and Related Forms (0925-0001) and Ruth L. Kirschstein National Research Service Award (NRSA) Applications and Related Forms (0925-0002). Both 0925-0001 and 0925-0002 will expire on June 30, 2012. In 2009, application and pre-award related forms were simultaneously submitted under both 0925-0001 and 0925-0002. This 0925-0001 submission consolidates application and other related pre-award reporting requirements previously collected under 0925-0001 and 0925-002. Post-award reporting requirements previously collected under 0925-0001 and 0925-0002, and the New Research Performance Progress Report (RPPR), are similarly consolidated and concurrently submitted under 0925-0002. 2015-08-31-04:00 Active Saleda Perryman No No No 94326 2051794 0

398 Forms and Instructions (Paper) No Health Health Care Services
Yes Yes Fillable Printable Instruction Attachment 11 Supplemental Instructions for PHS 398 and PHS 416 Applications.doc Yes Yes Paper Only Instruction Attachment 4A PHS 398 Paper Application Instructions.doc Yes Yes Paper Only Instruction Attachment 4B PHS 398 NRSA Data Table Format Instructions.docx 3B NRSA Data Table Format Yes Yes Paper Only Form Attachment 3B PHS 398 NRSA Data Table Format.docx 3A Paper Application Form Yes Yes Paper Only Form Attachment 3A PHS 398 Paper Application Forms.doc
Federal Government 8389 293615 0

398 Forms and Instructions (Electronic) No Health Health Care Services
5A Components of an Application to NIH or Other PHS Agencies Yes Yes Fillable Fileable Form and instruction Attachment 5A PHS 398 and SF 424 (R&R) Form Components.doc 5G PHS 398 Research Training Plan Form Yes Yes Fillable Fileable Form and instruction Attachment 5G PHS 398 Research Training Program Plan Form.doc Yes Yes Fillable Printable Instruction Attachment 11 Supplemental Instructions for PHS 398 and PHS 416 Applications.doc 5B Completing PHS 398 Components Yes Yes Fillable Fileable Form and instruction Attachment 5B PHS 398 Research Plan Instructions.doc 5C PHS 398 Research Plan Yes Yes Fillable Fileable Form and instruction Attachment 5C PHS 398 Research Plan Form.doc 5D Supplemental Instructions for Preparing an Individual Research Career Development Award Application ("K" Series) Yes Yes Fillable Fileable Form and instruction Attachment 5D PHS 398 Career Development Form Instructions.doc 5E PHS 398 Career Development Form Yes Yes Fillable Fileable Form and instruction Attachment 5E PHS 398 Career Development Form.doc 5F Supplemental Instructions for Preparing an Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application Yes Yes Fillable Printable Form and instruction Attachment 5F PHS 398 Research Training Program Plan Form Instructions.doc
Federal Government 76312 1678864 0

PHS Fellowship Supplemental Form (electronic) No Health Health Care Services
6B PHS Fellowship Supplemental Form Yes Yes Fillable Fileable Form and instruction Attachment 6B PHS 398 Fellowship Supplemental Form.pdf 6A Completing PHS Fellowship Specific Components Yes Yes Fillable Fileable Form and instruction Attachment 6A PHS 398 Fellowship Supplemental Form Instructions.doc
Individuals or Households 4915 78640 0

416-1 No Health Health Care Services
Yes Yes Paper Only Instruction Attachment 7A PHS 416-1 Instructions.doc 7B Face Page Yes Yes Paper Only Form and instruction Attachment 7B PHS 416-1 Face Page 1.pdf 7C Face Page 3 Yes Yes Paper Only Form and instruction Attachment 7C PHS 416-1 Face Page 3.pdf 7D Project Performance Site Format Yes Yes Paper Only Form and instruction Attachment 7D PHS 416-1 Project Performance Site Format Page.pdf 7F SPONSOR/CO-SPONSOR BIOGRAPHICAL SKETCH Yes Yes Paper Only Form and instruction Attachment 7F PHS 416-1 Sponsor Biosketch Format Page.doc 7E Face Page 4 Yes Yes Paper Only Form and instruction Attachment 7E PHS 416-1 Face Page 4.pdf 7G Checklist Form Page Yes Yes Paper Only Form and instruction Attachment 7G PHS 416-1 Checklist Form Page.pdf 7H Continuation Page Yes Yes Paper Only Form and instruction Attachment 7H PHS 416-1 Continuation Page.pdf 7C Face Page 2 Yes Yes Paper Only Form and instruction Attachment 7C PHS 416-1 Face Page 2.pdf
Individuals or Households 30 300 0

416-5 No Health Health Care Services
Attachment 9 Fellowship Activation Notice Yes Yes Paper Only Form and instruction Attachment 9 PHS 416-5.pdf
Individuals or Households 3121 250 0

6031 No Health Health Care Services
Attachment 10 Payment Agreement Yes Yes Paper Only Form and instruction Attachment 10 PHS 6031.pdf
Individuals or Households 1559 125 0

2013-06-14-04:00

0925-0002 201311-0925-002 0925
             
        "PHS Research Performance Progress Report and Other Post-award Reporting"
             
          
        
National Institutes of Health and other Public Health Service grantees are required to submit interim and final progress reports and other post-award documents associated with the monitoring, oversight, and closeout of an award. This submission represents a consolidation of post-award reporting requirements into a revised data collection under the Paperwork Reduction Act, referred to here as 0925-0002 (previously known as Individual Ruth L. Kirschstein National Research Service Award Applications and Related Forms). The collection includes post-award reporting requirements previously collected under 0925-0001 and 0925-0002. Application and other pre-award related forms are similarly consolidated and concurrently submitted under 0925-0001. 2015-08-31-04:00 Active Saleda Perryman No No No 113717 647325 0

RPPR (or 2590 or 416-9) No Health Consumer Health and Safety
Yes Yes Fillable Fileable Instruction Attachment 4 - PHS 2590 Instructions.docx B SBIR ACT Progress Tracking Form Yes Yes Fillable Printable Form and instruction Attachment B NIH-CAP 2012-2013 ACT Progress Tracking Form-Baseline.doc A SBIR CTT Progress Tracking Form Yes Yes Fillable Printable Form and instruction Attachment A NIH-CAP 2012-2013 CTT Progress Tracking Form-Baseline.doc 3 RPPR Yes Yes Fillable Fileable Form Attachment 7 - RPPR Screen Shots.pdf Yes Yes Fillable Fileable Instruction Attachment 6 - PHS 416-9 Instructions.docx 1 PHS 2590 Yes Yes Fillable Printable Form Attachment 3 - PHS 2590 forms.pdf 2 PHS 416-9 Yes Yes Fillable Fileable Form and instruction Attachment 5 - PHS 416-9 forms.pdf
Private Sector 41300 615102 0

416-7 No Health Consumer Health and Safety
1 PHS 416-7 Yes Yes Fillable Fileable Form and instruction Attachment 9 - PHS 416-7 Instructions and Form.docx
Private Sector 3371 1686 0

PHS 2271 No Health Consumer Health and Safety
1 Form 2271 Yes Yes Fillable Fileable Form and instruction Attachment 10 - PHS 2271 Instructions and Form.docx
Private Sector 15500 3875 0

416-7 No Health Consumer Health and Safety
1 6031-1 Yes Yes Fillable Fileable Form and instruction Attachment 11 - PHS 6031-1 Instructions and Form.docx
Private Sector 1600 533 0

PHS 568 No Health Consumer Health and Safety
1 HHS 568 Yes Yes Fillable Fileable Form and instruction Attachment 12- HHS 568 instructions and form.doc
Private Sector 22681 1890 0

PHS 6031-1 No Health Consumer Health and Safety
1 Final Progress Report Yes Yes Fillable Fileable Form and instruction Attachment 13 - Final Progress Report Instructions.docx
Private Sector 22681 22681 0

iEdison No Health Consumer Health and Safety
1 HHS 568 Yes Yes Fillable Fileable Form and instruction Attachment 12- HHS 568 instructions and form.doc
Private Sector 6000 1500 0

PHS 3734 No Health Consumer Health and Safety
1 PHS 3734 Yes Yes Fillable Fileable Form and instruction Attachment 14 - PHS 3734 Instructions and Form.docx
Private Sector 584 58 0

2013-11-14-05:00

0925-0046 201304-0925-003 0925
             
        "Formative Research, Pretesting, and Customer Satisfaction of NCI's Communication and Education Resources (NCI)"
             
          
        
To help ensure that health messages, materials, strategies, and information services developed by NCI's Office of Communications (OC) have the potential of being received, understood, and accepted by their target audiences, OC will pretest them while they are under development. Respondents include cancer patients and their families, members of the public, health professionals, and organizations/groups that interface with these publics. 2016-05-31-04:00 Active Saleda Perryman No No No 33000 6600 0

Sub-study #1_Assessing Baccalaureate Nursing Students' Feedback on Clinical Research Class and Intentions to Pursue Further Education or Training No Health Consumer Health and Safety
1 CR Nurse Survey No No Printable Only Form and instruction #1_Attach1_Survey_CRNurse_ FINAL 3.11.docx
Individuals or Households 420 35 0

Sub-study #2_Assessing Cancer Information Service (CIS) Clients Actions After Receiving Clinical Trial Information No Health Consumer Health and Safety
1 CIS Survey Yes Yes Fillable Fileable Form and instruction CIS_#2_Attach B_Screenshot Survey.pdf
Individuals or Households 344 57 0

Sub-study #3_Playing for Life: Reducing the Negative Impact of Tobacco on Youth and Young Adults through Video Games, Gaming, and Gamification No Health Immunization Management
1 Interview Guide No No Printable Only Form and instruction Attachment B_Interview Guide_9-26-2013.docx
Individuals or Households 20 10 0

2013-05-22-04:00

0925-0177 201105-0925-004 0925
             
        "Special Volunteer and Guest Researcher Assignment"
             
          
        
Depending upon the Program, the information will be used by Scientific Directors/IC Directors or a delegated official at the Institute/Center level to determine that (1) the volunteer or guest researcher is qualified to do the proposed work; (2) the applicant has sufficient income to support himself/herself during the period of the assignment; (3) the Special Volunteer's proposed project or activity will provide a needed service to NIH; and (4) the Guest Researcher's proposed project will not interfere with ongoing Federal projects. 2014-07-31-04:00 Active Mikia Currie 3014350941 No No No 1660 166 0

Special Volunteers and Guest Researchers No Health Health Care Services
590 Special Volunteer and Guest Researchers Yes Yes Fillable Printable Form and instruction NIH590.pdf
Individuals or Households 1660 166 0

2011-07-24-04:00

0925-0208 201210-0925-004 0925
             
        "Collection of Customer Service, Demographic and Smoking/Tobacco Use Information from NCI Cancer Information Service (CIS) Clients"
             
          
        
The Cancer Information Service (CIS) currently collects demographic, customer service and smoking cessation information from clients contacting CIS by telephone and through LiveHelp (an online instant messaging service) for cancer information or smoking cessation assistance). A new service, information requested and provided by e-mail, will be implemented. As well, users can now find information about cancer on Facebook and through smartphones. Information is collected in order to properly plan, implement, and evaluate cancer education efforts and to provide smoking cessation services tailored to the individual client's needs. Since its inception in 1976, the CIS network has handled more than ten million calls from the public. The potential universe of Cancer Information Service (CIS) clients is almost 308 million respondents based on the U.S. Census estimate for 2010 of adults estimated to be 18 years and older. 2015-12-31-05:00 Active Saleda Perryman No No No 110000 2686 0

CIS Telephone Customer Service Questions (Appendix 1A_REV) No Health Illness Prevention
1 Telephone Customer Service Questions Yes Yes Fillable Fileable Form and instruction Appendix 1A_REV_Telephone Questions.doc
Individuals or Households 67400 1123 0

CIS Telephone Demographic Questions (Appendix 1A_REV) No Health Illness Prevention
2 Telephone Demographic Questions Yes Yes Fillable Fileable Form and instruction Appendix 1A_REV_Telephone Questions.doc
Individuals or Households 24300 810 0

CIS LiveHelp Questionnaire (Appendix 1B_REV) No Health Illness Prevention
3 LiveHelp Questionnaire Yes Yes Fillable Fileable Form and instruction Appendix 1B_REV_LiveHelp Questions.doc
Individuals or Households 7800 260 0

CIS Smoking Cessation Reactive Service "Intake" Questions (Appendix 1C_REV) No Health Illness Prevention
4 Smoking Cessation Reactive Service Client Questions Yes Yes Fillable Fileable Form and instruction Appendix 1C_REV_Reactive Smoking Cessation.doc
Individuals or Households 4200 350 0

CIS Smoking Cessation Reactive Service "Demographic" Questions (Appendix 1C_REV) No Health Illness Prevention
5 Smoking Cessation Reactive Service Demographic Questions Yes Yes Fillable Fileable Form and instruction Appendix 1C_REV_Reactive Smoking Cessation.doc
Individuals or Households 1300 43 0

CIS Smoking Cessation Proactive Follow-ups (Appendix 1D_REV) No Health Illness Prevention Individuals or Households 4000 67 0

CIS Email Intake Form (Appendix 2_REV) No Health Illness Prevention
6 Email Intake Yes Yes Fillable Fileable Form and instruction Appendix 2 Email Intake Form.docx
Individuals or Households 1000 33 0

2012-12-21-05:00

0925-0216 201309-0925-008 0925
             
        "The Framingham Study (NHLBI)"
             
          
        
The Framingham Study will continue to conduct examinations and morbidity and mortality follow-up in original, offspring and third generation participants to study the determinants of cardiovascular disease. 2016-10-31-04:00 Active Mikia Currie 3014350941 No No No 9380 4264 0

Original Cohort Forms No Health Illness Prevention
A7a Telephone Call to Set up Meeting Yes Yes Paper Only Form and instruction Attachment 7a- Telephone Contact.pdf A4 Medical Status Update Form Yes Yes Paper Only Form and instruction Attachment 4 - Medical Hx Update Form.pdf A2a Clinical Exam Form -Original Yes Yes Paper Only Form and instruction Attachment 2a - Clinic Exam, Original.pdf A7b Exam Scheduling Form Yes Yes Paper Only Form and instruction Attachment 7b- Exam Scheduling.pdf A6a Records Request Form Yes Yes Paper Only Form and instruction Attachment 6a- Records Request.pdf A2b Home Visit form-Original Yes Yes Paper Only Form and instruction Attachment 2b- Home Visit, Original.pdf A6b Informant Contact Form Yes Yes Paper Only Form and instruction Attachment 6b- Informant Contact.pdf
Individuals or Households 135 131 0

Offspring and Omni Group 1 Cohorts No Health Illness Prevention
A3 Food Frequency Form Yes Yes Paper Only Form and instruction Attachment 3- FFQ, Offspring and Omni Grp 1.pdf 6a Records Request Form Yes Yes Paper Only Form and instruction Attachment 6a- Records Request.pdf A4 Health Status Update Form Yes Yes Paper Only Form and instruction Attachment 4 - Medical Hx Update Form.pdf A14 Consent Forms Yes Yes Paper Only Form and instruction Attachment 14- Annual Newsletter.pdf 1b Home Visit/Nursing Home Visit Form No No Paper Only Form and instruction Attachment 1b- Home Visit, Offspring & Omni Grp 1.pdf 1a Clinical Exam Form No No Paper Only Form and instruction Attachment 1a - Clinic Exam, Offspring & Omni Grp 1.pdf 6b Informant Contact Form Yes Yes Paper Only Form and instruction Attachment 6b- Informant Contact.pdf 7a Initial Telephone Contact Form Yes Yes Paper Only Form and instruction Attachment 7a- Telephone Contact.pdf
Individuals or Households 4813 2235 0

Generation 3 and Omni Group 2 Cohorts No Health Illness Prevention
6a Records Request Form Yes Yes Paper Only Form and instruction Attachment 6a- Records Request.pdf A4 Health Status Update Form Yes Yes Paper Only Form and instruction Attachment 4 - Medical Hx Update Form.pdf 6b Informant Contact Form Yes Yes Paper Only Form and instruction Attachment 6b- Informant Contact.pdf
Individuals or Households 4432 1898 0

2013-10-31-04:00

0925-0281 201101-0925-009 0925
             
        "The Atherosclerosis Risk in Communities Study (ARIC)"
             
          
        
ARIC study was initiated in 1985 to examine the major factors contributing to the occurrence of and the trends for cardiovascular diseases among men, women, African Americans and white persons in four U.S. communities: Forsyth County, North Carolina; Jackson, Mississippi; suburbs of Minneapolis, Minnesota; and Washington County, Maryland. The cohort in Jackson is selected to represent only African American residents of the city. The primary objectives of the study are to: 1) investigate factors associated with both atherosclerosis and clinical cardiovascular diseases and 2) measure occurrence of and trend in coronary heart disease (CHD) and relate them to community levels of risk factors, medical care, and atherosclerosis. 2014-03-31-04:00 Active Mikia Currie 3014350941 No No No 34539 20435 0

Participants No Health Public Health Monitoring
2 SEMI-ANNUAL FOLLOW-UP FORM Yes Yes Paper Only Form and instruction Attach #8.pdf 1 Clinic Examination Yes Yes Paper Only Form and instruction Attach #7 .docx
Individuals or Households 32799 20221 0

Participants (Next of Kin) No Health Public Health Monitoring
1 Clinic Examination Yes Yes Paper Only Form and instruction Attach #7 .docx 2 SEMI-ANNUAL FOLLOW-UP FORM Yes Yes Paper Only Form and instruction Attach #8.pdf
Individuals or Households 400 67 0

Physicians (or coroner) (for CHD) No Health Public Health Monitoring
1 survey Yes Yes Paper Only Form and instruction Attach #9.pdf
Individuals or Households 420 70 0

Physician (for heart failure) No Health Public Health Monitoring
1 survey Yes Yes Paper Only Form and instruction Attach #9.pdf
Individuals or Households 920 77 0

2011-03-21-04:00

0925-0299 201307-0925-002 0925
             
        "NIH Intramural Research Training Award, Program Application (OD)"
             
          
        
The Office of Intramural Training & Education (OITE) administers a variety of programs and initiatives to recruit pre-college through post-doctoral educational level individuals into the National Institutes of Health Intramural Research Program (NIH-IRP) to facilitate develop into future biomedical scientists. To identify qualified prospective students, the OITE has developed an application that contains the following target areas of assessment: personal information, eligibility criteria, contact information, student identification number, training program selection, scientific discipline interests, educational history, standardized examination scores, reference information, resume components, employment history, employment interests, dissertation research details, letters of recommendation, financial aid history, sensitive data, future networking contact, travel information, as well as feedback questions about interviews and application submission experiences. NIH investigators directly involved in the evaluation of prospective trainees will use information contained in the application. 2016-08-31-04:00 Active Saleda Perryman No No No 39600 18355 0

Summer Internship Program Biomedical Research (SIP) No Workforce Management Training and Employment
1 SIP Yes Yes Fillable Fileable Form and instruction A01-SIP.pdf
Individuals or Households 6820 6820 0

Biomedical Engineering Summer Intership Program (BESIP) No Workforce Management Training and Employment
2 BESIP Yes Yes Fillable Fileable Form and instruction A02-BESIP.pdf
Individuals or Households 80 80 0

Post-baccalaureate Training Program (PBT) No Workforce Management Training and Employment
3 PBTP Yes Yes Fillable Fileable Form and instruction A03-PBTP.pdf
Individuals or Households 1885 1885 0

Community College Summer Enrichment Program (CCSEP) No Workforce Management Training and Employment
4 CCSEP Yes Yes Fillable Fileable Form and instruction A04-CCSEP.pdf
Individuals or Households 100 100 0

Technical Training Program (PBT) No Workforce Management Training and Employment
5 TTP No No Fillable Fileable Form and instruction A05-TTP.pdf
Individuals or Households 115 115 0

Graduate Partnerships Program (GPP) - Application (Select Institutional Partnerships) No Workforce Management Training and Employment
6c GPPc Yes Yes Fillable Fileable Form and instruction A06c-GPP-IndividualShortForm.pdf 6b GPPb Yes Yes Fillable Fileable Form and instruction A06b-GPP-InstitutionalShortForm.pdf 6a GPPa Yes Yes Fillable Fileable Form and instruction A06a-GPP-InstitutionalLongForm.pdf
Individuals or Households 250 250 0

Graduate Partnerships Program (GPP) - Application (Select Institutional Partnerships and Individual) No Workforce Management Training and Employment
6c GPPc Yes Yes Fillable Fileable Form and instruction A06c-GPP-IndividualShortForm.pdf 6b GPPb Yes Yes Fillable Fileable Form and instruction A06b-GPP-InstitutionalShortForm.pdf 6a GPPa Yes Yes Fillable Printable Form and instruction A06a-GPP-InstitutionalLongForm.pdf
Individuals or Households 140 140 0

National Graduate Student research Conference (NGSRC) No Workforce Management Training and Employment
7 NGSRC Yes Yes Fillable Fileable Form and instruction A07-NGSRC.pdf
Individuals or Households 800 800 0

Undergraduate Scholarship Program (UGSP) No Workforce Management Training and Employment
8 UGSP Yes Yes Fillable Fileable Form and instruction A08-UGSP.pdf
Individuals or Households 200 200 0

Alumni Database No Workforce Management Training and Employment
9 Alumni Database Yes Yes Fillable Fileable Form and instruction A09-AlumniDatabase.pdf
Individuals or Households 1900 1900 0

UGSP - Certificate of Eligibility (Completed by Applicant) No Workforce Management Training and Employment
13 Certification Form No No Fillable Fileable Form and instruction A13-UGSP-CertificationForm.pdf
Individuals or Households 200 10 0

UGSP - Certificate of Eligibility (Completed by University Staff) No Workforce Management Training and Employment
13 Certificate Form Yes Yes Fillable Fileable Form and instruction A13-UGSP-CertificationForm.pdf
Individuals or Households 200 50 0

UGSP - Deferment Form (Completed by Applicant) No Workforce Management Training and Employment
14 Deferment Form Yes Yes Fillable Fileable Form and instruction A14-UGSP-DefermentForm.pdf
Individuals or Households 40 2 0

UGSP - Deferment Form (Completed by University Staff) No Workforce Management Training and Employment
14 Deferment Form Yes Yes Fillable Fileable Form and instruction A14-UGSP-DefermentForm.pdf
Individuals or Households 40 10 0

Reference Recommendation Letters for All Programs No Workforce Management Training and Employment
16 Recommendation Letters Yes Yes Fillable Fileable Form and instruction A16-RecommendationLetters.pdf
Individuals or Households 23235 5809 0

Survey Race-Ethnicity-Gender-Birth Year No Workforce Management Training and Employment
10 Optional Information Yes Yes Fillable Fileable Form and instruction A10-OptionalInformation.pdf
Individuals or Households 3073 154 0

Time to Complete Application Form No Workforce Management Training and Employment
11 Time to Complete Yes Yes Fillable Fileable Form and instruction A11-TimeToComplete.pdf
Individuals or Households 492 25 0

GPP Interview Experience No Workforce Management Training and Employment
12 GPP Interview Experience Yes Yes Fillable Fileable Form and instruction A12-GPP-InterviewExperience.pdf
Individuals or Households 30 5 0

2013-08-21-04:00

0925-0348 201211-0925-003 0925
             
        "Hazardous Waste Worker Training"
             
          
        
This clearance request is for the information requirements in the final rule, 42 CFR Part 65 Hazardous Waste Worker Training. The National Institute of Environmental Health Sciences (NIEHS) has been given major responsibility for initiating a worker safety and health training program under Section 126 of the Superfund Amendments and Reauthorization Act (SARA) for hazardous waste workers and emergency responders. 2015-12-31-05:00 Active Saleda Perryman No No No 40 560 0

Hazardous Waste Worker Training/Grantees No Health Illness Prevention
1 Data Management System Yes Yes Fillable Fileable Form and instruction Information Collection Data Management System screenshots enlarged.doc
Private Sector 40 560 0

2012-12-10-05:00

0925-0361 201211-0925-002 0925
             
        "National Institutes of Health Loan Repayment Programs"
             
          
        
The Loan Repayment Programs are designed to provide repayment of existing eligible loans of up to $35,000 per year to qualified health professionals performing research in fields required by the NIH to support its mission. Approximately 1,675 new applicants and 800 renewal applicants are expected to submit application packages. 2014-06-30-04:00 Active Saleda Perryman No No No 16090 41664 0

Intramural/InitialApplications No Education Higher Education
Yes Yes Fillable Printable Instruction LRP Instructions for Data Collection Instruments.doc 1 Application Yes Yes Fillable Fileable Form LRP Data Collection Instruments.pdf
Individuals or Households 50 506 0

Intramural/Advisors and Supervisors No Education Higher Education
Yes Yes Fillable Printable Instruction LRP Instructions for Data Collection Instruments.doc 1 Application Yes Yes Fillable Fileable Form LRP Data Collection Instruments.pdf
Individuals or Households 50 50 0

Intramural/Recommenders No Education Higher Education
1 Application Yes Yes Fillable Fileable Form LRP Instructions for Data Collection Instruments.doc Yes Yes Fillable Printable Instruction LRP Instructions for Data Collection Instruments.doc
Individuals or Households 140 70 0

Intramural/ Financial Institutions No Education Higher Education
Yes Yes Fillable Printable Instruction LRP Instructions for Data Collection Instruments.doc 1 Application Yes Yes Fillable Fileable Form LRP Data Collection Instruments.pdf
Individuals or Households 10 3 0

Extramural/ Initial Applicants No Education Higher Education
Yes Yes Fillable Printable Instruction LRP Instructions for Data Collection Instruments.doc Yes Yes Paper Only Instruction Instructions for Application Package.pdf 1 Survey Yes Yes Paper Only Form 2674-1 Applicant Informaiton with NIH Commons OMB[1][1].pdf 1 Application Yes Yes Fillable Fileable Form LRP Data Collection Instruments.pdf
Individuals or Households 2050 22038 0

Extramural/ Advisors and Supervisors No Education Higher Education
Yes Yes Fillable Printable Instruction LRP Instructions for Data Collection Instruments.doc 1 Application Yes Yes Fillable Fileable Form LRP Data Collection Instruments.pdf
Individuals or Households 1840 1840 0

Extramural/ Recommenders No Education Higher Education
1 Application Yes Yes Fillable Fileable Form LRP Data Collection Instruments.pdf Yes Yes Fillable Printable Instruction LRP Instructions for Data Collection Instruments.doc
Individuals or Households 6150 3075 0

Extramural/ Financial Institutions No Education Higher Education
Yes Yes Fillable Printable Instruction LRP Instructions for Data Collection Instruments.doc 1 Application Yes Yes Fillable Fileable Form LRP Data Collection Instruments.pdf
Individuals or Households 100 25 0

Intramural/ Renewal Applications No Education Higher Education
1 Application Yes Yes Fillable Fileable Form LRP Data Collection Instruments.pdf Yes Yes Fillable Printable Instruction LRP Instructions for Data Collection Instruments.doc
Individuals or Households 50 371 0

Intramural/ Advisors and Supervisors No Education Higher Education
1 Application Yes Yes Fillable Fileable Form LRP Instructions for Data Collection Instruments.doc Yes Yes Fillable Printable Instruction LRP Instructions for Data Collection Instruments.doc
Individuals or Households 50 110 0

Extramural/ Renewal Applicants No Education Higher Education
Yes Yes Fillable Printable Instruction LRP Instructions for Data Collection Instruments.doc 1 Application Yes Yes Fillable Fileable Form LRP Data Collection Instruments.pdf
Individuals or Households 1200 10296 0

Extramural/ Advisors and Supervisors No Education Higher Education
1 Application Yes Yes Fillable Fileable Form LRP Data Collection Instruments.pdf Yes Yes Fillable Printable Instruction LRP Instructions for Data Collection Instruments.doc
Individuals or Households 900 1530 0

Extramural/ Recommenders No Education Higher Education
1 Application Yes Yes Fillable Fileable Form LRP Data Collection Instruments.pdf Yes Yes Fillable Printable Instruction LRP Instructions for Data Collection Instruments.doc
Individuals or Households 3500 1750 0

2012-11-09-05:00

0925-0378 201310-0925-004 0925
             
        "Application for the Pharmacology Research Associate Program"
             
          
        
The Pharmacology Research Associate (PRAT) Program will use the applicant and referee information to award opportunities for training and experience in laboratory or clinical investigation to individuals with a Ph.D. degree in pharmacology or a related science, M.D. or other professional degree through appointments as PRAT Fellows at the National Institutes of Health or the Food and Drug Administration. The goal of the program is to develop leaders in pharmacological research for key positions in academic, industrial, and Federal research laboratories. 2016-11-30-05:00 Active Saleda Perryman No No No 100 331 0

Applicants No Health Public Health Monitoring
1 PRAT NIH 2121-1 Yes Yes Fillable Fileable Form and instruction Attachment 4 PRAT Application Primary (NIH 2121-1).pdf 3 Application Preceptor Selection Verification Yes Yes Fillable Fileable Form and instruction Attachment 6 PRAT Application Preceptor Selection Verification (2).pdf
Individuals or Households 25 200 0

Referees No Health Health Care Services
3 PRAT Preceptor Selection Verification Yes Yes Fillable Fileable Form and instruction Attachment 6 PRAT Application Preceptor Selection Verification (2).pdf 2 PRAT 2721-2 Yes Yes Fillable Fileable Form and instruction Attachment 5 PRAT NIH 2721-2 Application Evaluation Request.pdf
Individuals or Households 75 131 0

2013-11-25-05:00

0925-0406 201308-0925-001 0925
             
        "Agricultural Health Study:  A Prospective Cohort Study of Cancer and Other Diseases Among Men and Women in Agriculture"
             
          
        
The Agricultural Health Study (AHS) program staff is requesting approval of this revision to add a new dust specimen component to the ongoing Agricultural Health Study (AHS). AHS is a cohort study of 89,568 licensed pesticide applicators (both private and commercial applicators)and the spouses of the private applicators in Iowa and North Carolina that is to be followed for 20 years or more. The primary objective of the AHS study remains to be determination of the health effects resulting from occupational and environmental exposures in agriculture. This revision is to initiate and complete a new dust specimen component as part of the ongoing Study of Biomarkers of Exposures and Effects in Agriculture (BEEA). The dust component will include a brief paper-and-pen questionnaire mailed to the participant in advance of the home visit. At the home visit, the study phlebotomist will collect the participant's disposable vacuum bag (or empty the dust from vacuums without disposable bags). We are using similar procedures to ones that have been employed on other NCI studies to obtain information about the dust specimen and to collect and ship the dust specimen. 2016-09-30-04:00 Active Saleda Perryman No No No 25711 10678 0

Attachment 25: Paper/pen, CAWI or CATI Instruments for Private Applicators for AHS No Health Consumer Health and Safety
8 CAWI-CATI Yes No Fillable Fileable Form and instruction Attachment 25-3_CAWI_CATI_Ppt_Survey_Partial.pdf 6 Paper/pen, CAWI or CATI Yes Yes Fillable Printable Form and instruction Attachment 25-1_CAWI_Ppt_Intro.docx 9 Paper and Pencil No No Printable Only Form and instruction Attachment 25-4_Ppt_PaperPenSurvey.docx 7 CATI No No Printable Only Form and instruction Attachment 25-2_CATI_Ppt_Intro.doc
Private Sector 13855 5773 0

Attachment 25: Paper/pen, CAWI or CATI for Spouses for AHS No Health Consumer Health and Safety
10 CAWI Yes Yes Fillable Fileable Form and instruction Attachment 25-1_CAWI_Ppt_Intro.docx 12 CAWI-CATI Yes Yes Fillable Fileable Form and instruction Attachment 25-3_CAWI_CATI_Ppt_Survey_Placeholder.docx 11 CATI No No Printable Only Form and instruction Attachment 25-2_CATI_Ppt_Intro.doc 13 Paper/Pen No No Printable Only Form and instruction Attachment 25-4_Ppt_PaperPenSurvey.docx
Private Sector 10201 4250 0

Attachment 9: Reminder, Missing or Damaged Scripts for AHS No Health Consumer Health and Safety
4 Damaged or Missing Buccal Cell Sample Call Script No No Printable Only Form and instruction Attachment 09-5_Phase_IV_Missing_Damaged_Buccal_Cell_Sample_Script.docx 3 Missing Buccal Cell Consent Forms Call Script No No Printable Only Form and instruction Attachment 09-4_Phase_IV_Missing_Consent_Buccal_Cell_Script.docx 2 Reminder Call Script for North Carolina Buccal Cell Respondents No No Printable Only Form and instruction Attachment 09-3_Phase_IV_Remind_Call_NC_Buccal_Cell_Script.docx 1 Reminder Call Script for Iowa Buccal Cell Respondents No No Printable Only Form and instruction Attachment 09-2_Phase_IV_Remind_Call_IO_Buccal_Cell_Script.docx
Private Sector 100 8 0

Attachment 20 or 21: BEEA CATI Screener for AHS No Health Consumer Health and Safety
1 Attachment 20: BEEA CATI Script Yes No Printable Only Form and instruction Attachment 20_BEEA_CATI Eligibility Script_Random Select Group_Dust.doc 3 CATI Eligibility Script_Recently Exposed Respondents Yes No Printable Only Form and instruction Attachment 21_BEEA_CATI_Eligibility_Script_Recently_Exposed.docx
Private Sector 480 160 0

Attachment 19: BEEA Home Visit CAPI, Blood, amp; Urine x 1 for AHS No Health Consumer Health and Safety
3 BEEA Home Visit CAPI, Blood, & Urine x 1 Yes No Printable Only Form and instruction Attachment 19_CAPI_Questionnaire_Both_Groups - 03-22-10 rev.doc
Private Sector 160 240 0

Attachment 10: BEEA Schedule Home Visit Scripts for AHS No Health Consumer Health and Safety
3 BEEA North Carolina Schedule PostApp Visit Script No No Printable Only Form and instruction Attachment 10-3_BEEA_NC_Sched_PostApp_Visit_Script.docx 2 BEEA Iowa Schedule PostApp Visit Script No No Printable Only Form and instruction Attachment 10-2_BEEA_IO_Sched_PostApp_Visit_Script.docx 1 BEEA Previsit Reminder Script No No Printable Only Form and instruction Attachment 10-1_BEEA_Previsit_Reminder_CallScripts.docx
Private Sector 60 5 0

Attachment 19: BEEA Home Visit CAPI, Blood, amp; Urine x 3 No Health Consumer Health and Safety
5 BEEA Home Visit CAPI, Blood, & Urine x 3 Yes No Printable Only Form and instruction Attachment 19_CAPI_Questionnaire_Both_Groups - 03-22-10 rev.doc
Private Sector 60 30 0

Attachment 26: Paper/pen, CAWI, and CATI for Proxy for AHS No Health Consumer Health and Safety
15 CATI Proxy No No Printable Only Form and instruction Attachment 26-2_Proxy_CATI_Intro.doc 14 CAWI Proxy Yes Yes Fillable Fileable Form and instruction Attachment 26-1_Proxy_CAWI_Intro_Interview_Script.pdf 16 CAWI-CATI Proxy Yes Yes Fillable Fileable Form and instruction Attachment 26-3_CAWI_Proxy_Survey.pdf 17 Paper-Pen Proxy No No Printable Only Form and instruction Attachment 26-4_Proxy_PaperPenSurvey.docx
Private Sector 635 159 0

Attachments: 17.5 -17.6; 18; 22.2 consent forms, show cards, and dust questionnaire No Health Consumer Health and Safety
1 BEEA Show Cards Yes No Paper Only Form and instruction Attachment 17-5 17-6_BEEA_ShowCards_burden.pdf 3 BEEA Dust Specimen Questionnaire Yes No Paper Only Form and instruction Attachment 22-2_Dust Questionnaire_columns.doc 2 BEEA Consent Form - Dust Yes No Paper Only Form and instruction Attachment 18_BEEA_Consent Forms_Dust.pdf
Private Sector 160 53 0

2013-09-30-04:00

0925-0407 201210-0925-003 0925
             
        "Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) (NCI)"
             
          
        
This is a request for a revision due to the replacement of the Supplemental Questionnaire with the Medication Use Questionnaire (MUQ). The previous submission was approved in September, 2011. This trial was designed to determine if cancer screening for prostate, lung, colorectal, and ovarian cancer can reduce mortality from these cancers which currently cause an estimated 255,700 deaths annually in the U.S. The design is a two-armed randomized trial of men and women aged 55 to 74 at entry. OMB first approved this study in 1993 and has approved it every 3 years since then. Recruitment was completed in 2001, baseline cancer screening was completed in 2006, and data collection continues on the current cohort of 94,000 participants who are actively being followed. The additional follow-up will provide data that will clarify further the long term effects of the screening on cancer incidence and mortality for the four targeted cancers. Further, demographic and risk factor information may be used to analyze the differential effectiveness of cancer screening in high versus low risk individuals. 2015-12-31-05:00 Active Saleda Perryman No No No 193760 31813 0

Annual Study Update (ASU) for PLCO No Health Consumer Health and Safety
1 Annual Study Update (ASU) No No Printable Only Form and instruction Attach_02_ASU_9-27-12.pdf
Individuals or Households 94000 7833 0

Health Status Questionnaire (HSQ) for PLCO No Health Consumer Health and Safety
3B Health Status Questionnaire (Female-HSQ) No No Printable Only Form and instruction Attach_03B_HSQ-Female9_24_12.doc 3A Health Status Questionnaire (Male-HSQ) No No Printable Only Form and instruction Attach_03A_HSQ-Male9_24_12.doc
Individuals or Households 2000 167 0

Supplemental Questionnaire (SQX) for PLCO No Health Consumer Health and Safety
3 Supplemental Questionnaire (SQX). Yes No Fillable Fileable Form Attach_05_SQX.doc
Individuals or Households 0 0 0

Script for Non-responders to ASU No Health Consumer Health and Safety
6 Script for ASU Non-response Yes Yes Fillable Printable Form and instruction Attach_6_ASU_Telephone_Script_9_24_12.docx
Individuals or Households 3760 313 0

Medication Use Questionnaire (MUQ) for PLCO No Health Consumer Health and Safety
5 Medication Use Questionnaire (MUQ) No No Printable Only Form and instruction Attach_5_MUQ PLCO with Cover.pdf
Individuals or Households 94000 23500 0

2012-12-21-05:00

0925-0414 201306-0925-001 0925
             
        "Women's Health Initiative Observational Study (NHLBI)"
             
          
        
This study will be used by the NIH to evaluate risk factors for chronic disease among older women by developing and following a large cohort of postmenopausal women and relating subsequent disease development to baseline assessments of historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study will complement the clinical trial (which has received clinical exemption) and provide additional information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast and colorectal cancer, and osteoporotic fractures. Continuation of follow-up for ascertainment of medical history update forms will provide essential data for outcomes assessment for this population of aging women. 2016-07-31-04:00 Active Mikia Currie 3014350941 No No No 42448 13927 0

OS Participants No Health Health Care Services
33 Medical History Update No No Paper Only Form and instruction F33-OMB-2013.pdf 20 Personal Information Update No No Paper Only Form and instruction Form 20.pdf 151 Activities of Daily Life No No Paper Only Form and instruction WHI Form 151 Activities of Daily Life.pdf 156 Supplemental Questionaire No No Paper Only Form and instruction F156 Supplemental-OMB-01-22-13.pdf
Individuals or Households 41495 13832 0

Next of Kin No Health Illness Prevention
23 Search to Locate Participants No No Paper Only Form and instruction F23V8.2.pdf 120 Initial Notification of Death No No Paper Only Form and instruction F120V8.1.pdf
Individuals or Households 936 94 0

Physician/Office Staff No Health Illness Prevention
120 Initial Notification of Death No No Printable Only Form and instruction F120V8.1.pdf
Individuals or Households 17 1 0

2013-07-08-04:00

0925-0417 201112-0925-005 0925
             
        "Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought (OPERA)"
             
          
        
This request is for Office of Management and Budget (OMB) approval of a revision of a currently approved collection resulting from the development of revised regulations regarding the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50, Subpart F) and Responsible Prospective Contractors (45 CFR Part 94). 2015-02-28-05:00 Active Mikia Currie 3014350941 No No No 135175 664130 0

Initial Reports- 42 CFR 50.605(b)(1) and (b)(3) (Reporting) No Health Health Care Services Private Sector 950 1900 0

Subsequent Reports under 42 CFR 50.605(a)(3)(iii) and (b)(2) (Reportimg) No Health Health Care Services Individuals or Households 55 110 0

Subsequent Reports under 42 CFR 50.606(a) (Reporting) No Health Health Care Services Individuals or Households 20 200 0

42 CFR 50.604(i)-Institutional files (Recordkeeping) No Health Health Care Services Individuals or Households 2000 8000 0

42 CFR 50.605(a)(5) - Institutions (Disclosure) No Health Public Health Monitoring Private Sector 2000 10000 0

42 CFR - 50.604(c)(1) - Investigators (Disclosure) No Health Public Health Monitoring Individuals or Households 500 500 0

42 CFR 50.604(a) (Disclosure) No Health Public Health Monitoring Individuals or Households 3000 243000 0

42 CFR 50.604(b) (Disclosure) No Health Public Health Monitoring Individuals or Households 38000 19000 0

42 CFR 50.604(b) (Disclosure) No Health Public Health Monitoring Private Sector 2000 12000 0

42 CFR 50.604(d) (Disclosure) No Health Public Health Monitoring Private Sector 3000 3000 0

42 CFR 50.604(f) (Disclosure) No Health Public Health Monitoring Private Sector 2000 2000 0

42 CFR 50.605(a)(1) (Disclosure) No Health Public Health Monitoring Private Sector 2000 152000 0

42 CFR 50.605(a)(3) (Disclosure) No Health Public Health Monitoring Private Sector 500 1500 0

42 CFR 50.605(a)(3)(i) (Disclosure) No Health Public Health Monitoring Individuals or Households 50 4000 0

42 CFR 50.605(a)(3)(ii) (Disclosure) No Health Public Health Monitoring Individuals or Households 50 4000 0

42 CFR 50.605(a)(3)(iii) (Disclosure) No Health Public Health Monitoring Individuals or Households 50 50 0

42 CFR 50.605(a)(4) (Disclosure) No Health Public Health Monitoring Individuals or Households 950 11400 0

42 CFR 50.605(b)(4) (Reportimg) No Health Health Care Services Individuals or Households 950 950 0

42 CFR 50.604(e)(1) - Investigators (Disclosure) No Health Health Care Services Individuals or Households 38000 152000 0

42 CFR 50.604(e)(2) - Investigators (Disclosure) No Health Public Health Monitoring Individuals or Households 38000 38000 0

42 CFR 50.604(e)(3) - Investigators (Disclosure) No Health Public Health Monitoring Individuals or Households 950 475 0

42 CFR 50.606(c) (Disclosure) No Health Public Health Monitoring Individuals or Households 150 45 0

2012-02-16-05:00

0925-0424 201110-0925-004 0925
             
        "National Institutes of Health Construction Grants"
             
          
        
The purpose of the regulations is to govern the awarding and administration of grants awarded by NIH and its components for construction of new buildings and the alteration, renovation, remodeling, improvement, expanision, and repair of existing buildings. 2014-11-30-05:00 Active Saleda Perryman No No No 16481 16481 0

Recordkeeping 52b.10(g) No Health Consumer Health and Safety Private Sector 15600 15600 0

Reporting 52b.9(b) No Health Consumer Health and Safety Private Sector 1 1 0

Reporting 52b.10(f) No Health Consumer Health and Safety Private Sector 60 60 0

Reporting 52b.10(g) No Health Consumer Health and Safety Private Sector 720 720 0

Reporting 52b.11(b) No Health Consumer Health and Safety Private Sector 100 100 0

2011-11-30-05:00

0925-0474 201108-0925-006 0925
             
        "Generic Clearance for Satisfaction Surveys of Customers (CSR)"
             
          
        
The Center for Scientific Review (CSR), NIH is responsible for: formulating grant award peer review policies; receiving most Public Health Service research and research training applications (almost 40,000 a year); assigning applications to peer review groups; and directing scientific and technical review of these applications. Input from our customers is essential to our efforts to improve our operations and provide excellent services. The major respondent group is customers,i.e. grant applicants/researchers/investigators. 2014-10-31-04:00 Active Saleda Perryman No No No 5075 1438 0

Chair Training No Health Health Care Services
1 Chair Training Yes Yes Fillable Fileable Form and instruction CSR ChairTraining survey rev.docx
Individuals or Households 500 83 0

Fellowship Review Evaluation No Health Health Care Services
1 Survey Yes Yes Fillable Fileable Form and instruction FellowshipReviewScreenshot[1].pdf
Individuals or Households 100 17 0

Study Section Chair Training Evaluation No Health Health Care Services
1 Survey Yes Yes Fillable Printable Form and instruction Early Career Reviewers.pdf
Individuals or Households 140 23 0

2012 IRG Stakeholder Survey No Health Health Care Services
1 2012 IRG Stakeholder Survey Yes Yes Fillable Fileable Form and instruction 2012 IRG Stakeholder Survey Screenshot 4.2013.pdf
Individuals or Households 180 45 0

Center for Scientific Review (CSR) - 2012 IRG Stakeholder Survey No Health Public Health Monitoring
1 CSR Review- 2012 IRG Survey- screen shots Yes Yes Fillable Printable Form and instruction 2012 IRG Stakeholder Survey -PSE.pdf
Individuals or Households 90 23 0

CSR New Chair Orientaion Survey No Health Consumer Health and Safety
1 CSR New Chair Orientation Survey - Screenshots Yes Yes Fillable Fileable Form and instruction CSR New Chair Orientation Survey Screenshot(2).pdf
Individuals or Households 90 29 0

2011-10-12-04:00

0925-0476 201206-0925-003 0925
             
        "Request for Generic Clearance to Conduct Voluntary Customer/Partner Surveys(NLM)"
             
          
        
NLM will collect and use information gathered through customer and/or partner surveys to identify strengths and weaknesses in current service provisions and to make improvements that are practical and feasible. 2015-07-31-04:00 Active Mikia Currie 3014350941 No No No 15000 3250 0

User Satisfaction Surevy for MICAD Users No Health Public Health Monitoring
1 Survey for MICAD Users screenshots Yes Yes Fillable Printable Form and instruction MICAD_survey_sceenshots_7_18_2012[1].pdf
Individuals or Households 300 10 0

WHR Consumer Focus Group Survey No Health Health Care Services
1 WHR Consumer Focus Group Survey Yes Yes Paper Only Form and instruction NLM-WHR-Consumer_Focus_Group-Survey Instrument.docx
Individuals or Households 24 36 0

WHR Professionals Focus Group Survey No Health Health Care Services
1 Focus Group No No Paper Only Form and instruction NLM-WHR-Professionals_Focus_Group-Survey Instrument.docx
Individuals or Households 50 75 0

2012-07-13-04:00

0925-0522 201211-0925-004 0925
             
        "The Sister Study:  Environmental and Generic Risk Factors for Breast Cancer"
             
          
        
The NIEHS Sister Study is a prospective epidemiological study to examine environmental and familial risk factors for breast cancer and other diseases in a high-risk cohort of 50,000 sisters of women who have had breast cancer. 2016-02-29-05:00 Active Mikia Currie 3014350941 No No No 50884 26855 0

Annual Updates No Health Illness Prevention
1 SIS_OMB_2012_WebScreenShots_20121024 Att 12 Yes Yes Fillable Fileable Form and instruction SIS_OMB_2012_WebScreenShots_20121024 Att 12.pdf 1 SIS_Annual_Forms_20121018_Att 1A No Paper Only Form and instruction SIS_Annual_Forms_20121018_Att 1A.pdf
Individuals or Households 33923 5654 0

Bi/Trienniel Follow-Up No Health Illness Prevention
1 SIS_Biennial_Triennial_FollowupScripts_20121018_Att 2C No Paper Only Form and instruction SIS_Biennial_Triennial_FollowupScripts_20121018_Att 2C.pdf 1 SIS_Triennial_Forms_20121018_Att 2A No Paper Only Form and instruction SIS_Triennial_Forms_20121018_Att 2A.pdf
Individuals or Households 16961 21201 0

Incident BC Case Follow-Up No Health Illness Prevention
1 survey Yes Yes Paper Only Form and instruction SISOMB2009att2.1ann&bipkg.pdf 2 survey Yes Yes Paper Only Form and instruction SISOMB2009att2.2bcfu.pdf
Individuals or Households 0 0 0

Incident Other Case Follow-Up No Health Illness Prevention
2 survey Yes Yes Paper Only Form and instruction SISOMB2009att2.2bcfu.pdf 1 survey Yes Yes Paper Only Form and instruction SISOMB2009att2.1ann&bipkg.pdf
Individuals or Households 0 0 0

Incident Case Medical Office Contact No Health Illness Prevention
1 survey Yes Yes Paper Only Form and instruction SISOMB2009att2.1ann&bipkg.pdf 2 survey Yes Yes Paper Only Form and instruction SISOMB2009att2.2bcfu.pdf
Individuals or Households 0 0 0

2013-02-04-05:00

0925-0538 201306-0925-007 0925
             
        "Health Information National Trends Survey 4 (HINTS 4) (NCI)"
             
          
        
HINTS provides NCI with a comprehensive assessment of the American public's current access to, and use of, information about cancer across the cancer care continuum from cancer prevention, early detection, diagnosis, treatment, and survivorship. The content of the survey focuses on understanding the degree to which members of the general population understand vital cancer prevention messages. More importantly, this NCI survey couples knowledge-related questions with inquiries into the communication channels through which understanding is being obtained, and assessment of cancer-related behavior. HINTS collects data using a stratified random sample of the non-institutionalized adult population (18+) in the 50 states and the District of Columbia. HINTS 4 methodology will consist of a mail survey conducted in 4 data collection cycles between 2011 and 2014. 2014-10-31-04:00 Active Saleda Perryman No No No 14066 7034 0

Cycle 1 Qx for Health Information National Trends Survey 4 (HINTS4) No Health Consumer Health and Safety
1 Appendix B2 Short Survey Yes No Paper Only Form and instruction Appendix B2 - short survey.pdf 1 Appendix B2: Full Survey Yes No Paper Only Form and instruction Appendix B2 - full survey.pdf 1 Cycle 1 Survey Potential Questions Yes No Paper Only Form and instruction Appendix B1 - List of Potential Items.pdf 1 Cycle 1 Qx Yes No Paper Only Form and instruction Appendix B2 - Survey (placeholder).doc
Individuals or Households 3533 1767 0

Cycle 3 Qx for Health Information National Trends Survey 4 (HINTS4) No Health Consumer Health and Safety
4 Cycle 3 Instrument - Spanish No No Printable Only Form and instruction Appendix D - Spanish Instrument.pdf 3 Cycle 3 Instrument - English No No Printable Only Form and instruction Appendix C - English Instrument.pdf
Federal Government 3500 1750 0

Cycle 4 Qx for Health Information National Trends Survey 4 (HINTS4) No Health Public Health Monitoring
4 List of Potential Questions for Cycle 4 Qx Yes No Paper Only Form and instruction Appendix B1 - List of Potential Items.pdf
Individuals or Households 3500 1750 0

Cycle 2 Qx for Health Information National Trends Survey 4 (HINTS4) No Health Consumer Health and Safety
2 List of Potential Questions for Cycle 2 Qx Yes No Paper Only Form and instruction Appendix B1 - List of Potential Items.pdf
Individuals or Households 3533 1767 0

2013-08-14-04:00

0925-0552 201208-0925-004 0925
             
        "National Diabetes Education Program Evaluation Survey of the Public"
             
          
        
The National Diabetes Education Program (NDEP) is a partnership of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) and more than 200 public and private organizations. The long?term goal of the NDEP is to reduce the burden of diabetes and pre-diabetes in the United States, and its territories, by facilitating the adoption of proven strategies to prevent or delay the onset of diabetes and its complications. The program audiences include the public, people at risk for diabetes, people with diabetes and their families, with special emphasis on racial/ethnic populations; health care providers; and payers and purchasers of health care and health care system policy makers. 2015-10-31-04:00 Active Saleda Perryman No No No 5859 650 0

Screening Interview with Ineligible Persons No Health Health Care Services
1 Survey Screener Yes Yes Paper Only Form and instruction Att A NDEP Natl Diab Survey Screener for OMB 22Aug2012 FINAL.doc
Individuals or Households 3759 125 0

Eligible Respondents No Health Health Care Services
1 NDEP Questionnaire Yes Yes Paper Only Form and instruction Att A NDEP Natl Diab Survey Final Annotated Questionnaire for OMB 22Aug2012 FINAL.doc
Individuals or Households 2100 525 0

2012-10-15-04:00

0925-0568 201209-0925-004 0925
             
        "FIC CareerTrac"
             
          
        
This data collection system is being developed to track, evaluate, and report short and long-term outputs, outcomes, and impacts of international trainees involved in health research training programs--specifically tracking this for at least ten years following training by having Principal Investigators enter data after trainees have completed the program. The data collection system provides a streamlined, web-based application permitting Principal Investigators to record career achievement progress by trainee on a voluntary basis. FIC, NIEHS, NCI, NLM and NIGMS management will use this data to monitor, evaluate, and adjust grants to ensure desired outcomes are achieved, comply with OMB Part requirements, respond to congressional inquiries, and guide future strategic and management decisions regarding the grant program. 2016-02-29-05:00 Active Saleda Perryman No No No 22500 6750 0

FIC CareerTrac - Using Form No Health Health Care Services
2 Revised CareerTrac Screenshots - ES Tenant Yes Yes Fillable Fileable Form and instruction Revised CareerTrac Screenshots - ES Tenant.docx 1 Screenshots for ES and FIC Yes Yes Fillable Fileable Form and instruction Screenshots - ES and FIC 9.28.2012.doc 3 Revised CareerTrac Screenshots FIC-NCI-SRP Yes Yes Fillable Fileable Form and instruction Revised CareerTrac Screenshots FIC-NCI-SRP.docx
Individuals or Households 9000 1500 0

FIC CareerTrac - Not Using form No Health Health Care Services
3 Revised CareerTrac Screenshots FIC-NCI-SRP Yes Yes Fillable Fileable Form and instruction Revised CareerTrac Screenshots FIC-NCI-SRP.docx 1 Screen Shots - ES and fIC 9.28.2012 Yes Yes Fillable Fileable Form and instruction Screenshots - ES and FIC 9.28.2012.doc 2 Revised CareerTrac Screenshots - ES Tenant Yes Yes Fillable Fileable Form and instruction Revised CareerTrac Screenshots - ES Tenant.docx
Individuals or Households 4500 2250 0

Trainees No Health Health Care Services
1 FIC CareerTrac Data Collection Form Yes Yes Fillable Fileable Form FIC CareerTrac Data Collection Form.docx 2 NCI CareerTrac Data Collection Form Yes Yes Fillable Fileable Form NCI CareerTrac Data Collection Form.docx 3 SRP CareerTrac Data Collection Form Yes Yes Fillable Fileable Form SRP CareerTrac Data Collection Form.docx
Individuals or Households 9000 3000 0

2013-02-19-05:00

0925-0584 201110-0925-002 0925
             
        "The Hispanic Community Health Study/ Study of Latinos (HCHS/SOL)(NHLBI)"
             
          
        
This project seeks to determine the prevalence of risk factors for cardiovascular disease among Hispanics living in the U.S. and their relationship to cardiovascular morbidity and mortality. 2014-12-31-05:00 Active Saleda Perryman No No No 17284 5309 0

Participants Follow-up Year 1 No Health Public Health Monitoring
1 Interview No No Fillable Fileable Form and instruction Interview Form Contact Yr1_English.doc
Individuals or Households 1333 1000 0

Participants Follow-up Year 2 No Health Public Health Monitoring
2 Interview Yes Yes Fillable Fileable Form and instruction Interview Form Contact Yr2_English.doc 1 Food Propensity No No Fillable Fileable Form Food Propensity Qx English.docm
Individuals or Households 5333 1333 0

Clinic Exam Procedures No Health Health Care Services
18 Social Cultural Yes Yes Paper Only Form and instruction Sociocultural_07-04-07.doc 17 Sleep Yes Yes Paper Only Form and instruction Sleep_6-29-07.doc 16 SF 12 Yes Yes Paper Only Form and instruction SF12v2 Health Survey_4-30-07.doc 15 Respiratory Yes Yes Paper Only Form and instruction Respiratory_7-05-07.doc 14 Physical Activity Yes Yes Paper Only Form and instruction Physical Activity_7-24-07.doc 13 Personal Information Yes Yes Paper Only Form and instruction Personal Information_7-02-07.doc 12 Oral Health Yes Yes Paper Only Form and instruction Oral Health_07-09-07.doc 9 Medication Use Yes Yes Paper Only Form and instruction Medication Survey_07-02-07.doc 8 Medical History Yes Yes Paper Only Form and instruction Medical History_6-28-07.doc 7 Informed Consent Yes Yes Paper Only Form and instruction Informed consent.doc 6 Hearing Exam Yes Yes Paper Only Form and instruction Hearing Exam Qx_07-04-07.doc 5 Health Care Use Yes Yes Paper Only Form and instruction Health Care Use_7-06-07.doc 4 Economic Yes Yes Paper Only Form and instruction Economic_7-04-07.doc 3 Dietary Behavior Yes Yes Paper Only Form and instruction Dietary Beh_6-25-07.doc 2 Dietary Recall and Supplement Use Yes Yes Paper Only Form and instruction Diet and Supplement Phone Script recall.doc 1 Alcohol Use Yes Yes Paper Only Form and instruction Alcohol Use_06-07-07.doc 19 Tobacco Use Yes Yes Paper Only Form and instruction Tobacco Use_6-18-07.doc 20 Weight History Yes Yes Paper Only Form and instruction Weight History_7-03-07.doc 21 Well Being Yes Yes Paper Only Form and instruction Wellbeing_5-25-07.doc 11 Occupation Yes Yes Paper Only Form and instruction Occupation_7-04-07.doc 10 Neuro Yes Yes Paper Only Form and instruction Neurocognitive Assessment_07-31-07.doc
Individuals or Households 0 0 0

Clinic Questionaires No Health Health Care Services
10 Neuro Yes Yes Paper Only Form and instruction Neurocognitive Assessment_07-31-07.doc 1 Alcohol Use Yes Yes Paper Only Form and instruction Alcohol Use_06-07-07.doc 8 Medical History Yes Yes Paper Only Form and instruction Medical History_6-28-07.doc 7 Informed Consent Yes Yes Paper Only Form and instruction Informed consent.doc 6 Hearing Exam Yes Yes Paper Only Form and instruction Hearing Exam Qx_07-04-07.doc 5 Health Care Use Yes Yes Paper Only Form and instruction Health Care Use_7-06-07.doc 4 Economic Yes Yes Paper Only Form and instruction Economic_7-04-07.doc 3 Dietary Behavior Yes Yes Paper Only Form and instruction Dietary Beh_6-25-07.doc 2 Dietary Recall and Supplement Use Yes Yes Paper Only Form and instruction Diet and Supplement Phone Script recall.doc 20 Weight History Yes Yes Paper Only Form and instruction Weight History_7-03-07.doc 19 Tobacco Use Yes Yes Paper Only Form and instruction Tobacco Use_6-18-07.doc 18 Social Cultural Yes Yes Paper Only Form and instruction Sociocultural_07-04-07.doc 17 Sleep Yes Yes Paper Only Form and instruction Sleep_6-29-07.doc 23 survey Yes Yes Paper Only Form and instruction Personal Information_11-21-08.doc 22 survey Yes Yes Paper Only Form and instruction Claudication_2-25-08.doc 21 Well Being Yes Yes Paper Only Form and instruction Wellbeing_5-25-07.doc 16 SF 12 Yes Yes Paper Only Form and instruction SF12v2 Health Survey_4-30-07.doc 15 Respiratory Yes Yes Paper Only Form and instruction Respiratory_7-05-07.doc 14 Physical Activity Yes Yes Paper Only Form and instruction Physical Activity_7-24-07.doc 12 Oral Health Yes Yes Paper Only Form and instruction Oral Health_07-09-07.doc 11 Occupation Yes Yes Paper Only Form and instruction Occupation_7-04-07.doc 9 Medication Use Yes Yes Paper Only Form and instruction Medication Survey_07-02-07.doc
Individuals or Households 0 0 0

Participant Telephone Interviews No Health Health Care Services
1 Recall Yes Yes Paper Only Form and instruction Diet and Supplement Phone Script recall.doc 7 survey Yes Yes Paper Only Form and instruction Exit Interview_10-24-08.doc 4 survey Yes Yes Paper Only Form and instruction Informant interview_10-20-08annotated.doc 6 survey Yes Yes Paper Only Form and instruction Annual Followup_Y3_11-03-08annotated.doc 5 survey Yes Yes Paper Only Form and instruction Annual Followup_Y2_11-03-08annotated.doc 2 survey Yes Yes Paper Only Form and instruction Annual Followup_Y1_11-03-08annotated.doc 3 Informant Yes Yes Paper Only Form and instruction Informant Phone Script_Follow-up.doc
Individuals or Households 0 0 0

Non Participant Components No Health Health Care Services
2 Informant Interview Yes Yes Fillable Fileable Form and instruction Informant interview_English.doc 1 Questionaire Yes Yes Fillable Fileable Form and instruction Physician Qx_English only.doc
Individuals or Households 1284 642 0

Focus Groups No Health Health Care Services
20 Weight History Yes Yes Paper Only Form and instruction Weight.doc 16 SF12 Yes Yes Paper Only Form and instruction SF12v2.doc 15 Respiratory Yes Yes Paper Only Form and instruction Respiratory_7-05-07.doc 14 Physical Activity Yes Yes Paper Only Form and instruction Physical.doc 18 Social Cultural Yes Yes Paper Only Form and instruction Sociocultural_07-04-07.doc 19 Tobacco Use Yes Yes Paper Only Form and instruction Tobacco.doc 17 Sleep Yes Yes Paper Only Form and instruction Sleep_6-29-07.doc 21 Well Being Yes Yes Paper Only Form and instruction Wellbeing_5-25-07.doc 11 Occupation Yes Yes Paper Only Form and instruction Occupation_7-04-07.doc 12 Oral Health Yes Yes Paper Only Form and instruction Oral.doc 13 Personal Information Yes Yes Paper Only Form and instruction Personal.doc
Individuals or Households 0 0 0

Food Propensity No Health Health Care Services
1 survey Yes Yes Paper Only Form and instruction FPQ English_11-04-08.doc
Individuals or Households 0 0 0

Participants Follow-up Year 3 to 6 No Health Public Health Monitoring
6 Interview Yes Yes Fillable Fileable Form and instruction Interview Form Contact Yr6_English.doc 5 Interview Yes Yes Fillable Fileable Form and instruction Interview Form Contact Yr 5_English.doc 4 Interview Yes Yes Fillable Fileable Form and instruction Interview Form Contact Yr4_English.doc 3 Interview Yes Yes Fillable Fileable Form and instruction Interview Form Contact Yr3_English.doc
Individuals or Households 9334 2334 0

2011-12-12-05:00

0925-0585 201102-0925-009 0925
             
        "PRETESTING OF NIAID'S HIV VACCINE RESEARCH EDUCATION INITIATIVE COMMUNICATION MESSAGES"
             
          
        
To help ensure that health messages, strategies, and information services developed by NIAID for the HIV Vaccine Research Education Initiative have the potential of being received, understood, and acted upon by their target audiences, NIAID will pretest them while they are under development. Respondents include: members of the populations most affected and infected by HIV/AIDS, specifically Blacks/African Americans, Hispanics/Latinos, and men who have sex with men (MSM) of all racial/ethnic groups; key influencers of these populations; health professionals; and organizations/groups that interface with these publics. 2014-04-30-04:00 Active Mikia Currie 3014350941 No No No 11529 4380 0

Self-Administered Customer Satisfaction Surveys of Meetings and Conference Sessions No Health Health Care Services
1 Survey Yes Yes Paper Only Form and instruction CSS Appendix 1 Participant Questionnaire 11-0503.doc
Individuals or Households 4530 483 0

2011-04-08-04:00

0925-0586 201204-0925-002 0925
             
        "Information Program on Clinical Trials: Maintaining a Registry and Results  Databank (NLM)"
             
          
        
The purpose of the clinical trials registry data bank is to enhance patient enrollment and provide a mechanism to track the progress of clinical trials. The information is intended to provide current and reliable information on the broadest possible scale to members of the public, including to physicians and researchers, about the existence, nature, enrollment status, location, eligibility criteria, sponsorship and progress of clinical trials. 2015-08-31-04:00 Active Mikia Currie 3014350941 No No No 168390 474873 0

Drug and Biologic - Mandatory Newly registered Trials No Health Consumer Health and Safety
Attachment 3 Registration Data Entry Yes Yes Fillable Printable Form Attachment_3_Registration_Data_Entry[1].pdf
Private Sector 5000 35000 0

Drug and Biologic - Voluntary Newly Registered Trials No Health Consumer Health and Safety
1 Registration Data Entry Yes Yes Fillable Fileable Form and instruction Attachment 3 Registration Data Entry.pdf
Private Sector 4000 28000 0

Device - Mandatory Newly registered Trials No Health Consumer Health and Safety
1 Registration Data Entry Yes Yes Fillable Fileable Form and instruction Attachment 3 Registration Data Entry.pdf
Private Sector 500 3500 0

Device - Voluntary Newly Registered Trials No Health Consumer Health and Safety
1 Registration Data Entry Yes Yes Fillable Fileable Form and instruction Attachment 3 Registration Data Entry.pdf
Private Sector 9600 19200 0

Other Newly Registered Trials No Health Consumer Health and Safety
1 Registration Data Entry Yes Yes Fillable Fileable Form and instruction Attachment 3 Registration Data Entry.pdf
Private Sector 6300 44100 0

Other Newly Registered Trials No Health Consumer Health and Safety
1 Registration Data Entry Yes Yes Fillable Fileable Form and instruction Attachment 3 Registration Data Entry.pdf
Private Sector 48000 96000 0

Drugs and Biologics (Ongoing Trials) No Health Consumer Health and Safety
1 registration Yes Yes Paper Only Form and instruction ClinicalTrials.gov - Registration Data Entry Screen Shots.pdf 2 results Yes Yes Paper Only Form and instruction ClinicalTrials gov - Results Reporting Data Entry Screen Shots.pdf
Private Sector 0 0 0

Drugs and Biologics (Ongoing Trials) No Health Consumer Health and Safety
1 registration Yes Yes Paper Only Form and instruction ClinicalTrials.gov - Registration Data Entry Screen Shots.pdf 2 results Yes Yes Paper Only Form and instruction ClinicalTrials gov - Results Reporting Data Entry Screen Shots.pdf
Private Sector 0 0 0

Devices (Ongoing Trials) No Health Consumer Health and Safety
2 results Yes Yes Paper Only Form and instruction ClinicalTrials gov - Results Reporting Data Entry Screen Shots.pdf 1 registration Yes Yes Paper Only Form and instruction ClinicalTrials.gov - Registration Data Entry Screen Shots.pdf
Private Sector 0 0 0

Devices (Ongoing Trials) No Health Consumer Health and Safety
2 results Yes Yes Paper Only Form and instruction ClinicalTrials gov - Results Reporting Data Entry Screen Shots.pdf 1 registration Yes Yes Paper Only Form and instruction ClinicalTrials.gov - Registration Data Entry Screen Shots.pdf
Private Sector 0 0 0

Drug and Biologic - Mandatory Newly Registered Trials No Health Consumer Health and Safety
1 Registration Data Entry Yes Yes Fillable Fileable Form and instruction Attachment 3 Registration Data Entry.pdf
Private Sector 40000 80000 0

Drug and Biologic - Voluntary Newly Registered Trials No Health Consumer Health and Safety
1 Registration Data Entry Yes Yes Fillable Fileable Form and instruction Attachment 3 Registration Data Entry.pdf
Private Sector 32000 64000 0

Device - Mandatory Newly Registered Trials No Health Consumer Health and Safety
1 Registration Data Entry Yes Yes Fillable Fileable Form and instruction Attachment 3 Registration Data Entry.pdf
Private Sector 4000 8000 0

Device - Voluntary Newly Registered Trials No Health Consumer Health and Safety
1 Registration Data Entry Yes Yes Fillable Fileable Form and instruction Attachment 3 Registration Data Entry.pdf
Private Sector 9600 19200 0

Basic Results Information (All Categories) No Health Consumer Health and Safety
1 Reporting Data Entry Yes Yes Fillable Fileable Form and instruction Attachment 4 Reporting Data Entry.pdf
Private Sector 9390 77873 0

2012-08-20-04:00

0925-0589 201302-0925-007 0925
             
        "Questionnaire Cognitive Interviewing and Pretesting (NCI)"
             
          
        
A generic clearance is requested from OMB for general questionnaire development and pretesting activities to be carried out in 2011-2014 by the staff of the Applied Research Program, in the Division of Cancer Control and Population Sciences. Four types of activities will be carried out: survey questionnaire development and pretesting based on cognitive interviewing methodology, research on the cognitive aspects of survey methodology, research on computer-user interface design for computer-assisted instruments (including Web-based surveys), also known as Usability Testing, and Pilot Household interviews. 2014-04-30-04:00 Active Mikia Currie 3014350941 No No No 4800 6000 0

Bundled Website Usability Testings #1 (ASA24) and #2 (GEM) No Health Consumer Health and Safety
2 #2_GEM Attach 2C 2D Survey and Guide Yes No Fillable Printable Form and instruction #2_Attach 2C 2D_Survey and Guide_GEM_FINAL.docx 1 #1_ASA 24 Screener and Guide Yes No Fillable Printable Form and instruction #1 Attach 1A and 1C Screener & Guide.docx
Individuals or Households 198 107 0

Sub-study #3_Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of Cycle 2 Instrument No Health Consumer Health and Safety
1 HINTS Cycle 2 Questionnaire No No Printable Only Form and instruction #3_AttachA_HINTS_Cycle 2 Qx_1-12-2012.doc 2 HINTS Cycle 2 Cognitive Interview Protocol No No Printable Only Form and instruction #3_AttachB_Cycle 2 Cog Interview Protocol 1-13-2012.doc 3 HINTS Cycle 2 Screener No No Printable Only Form and instruction #3_AttachE_HINTS_Cycle 2_Screener.docx
Individuals or Households 93 65 0

Sub-study #4: Cognitive Testing of the Family Life, Activity, Sun, Health, and Eating (FLASHE) Survey No Health Consumer Health and Safety
7 Teen Cognitive Interview Guide No No Printable Only Form and instruction Attach 4B-3 and 4B-4 Teenager Cognitive Interview Guide.docx 2 Parent Diet and Demographic Survey No No Printable Only Form and instruction Attach 4A-1 FLASHE Parent Diet And Demographics Survey.doc 3 Parent Physical Activity Survey and Checklist No No Printable Only Form and instruction Attach 4A-2 FLASHE Parent PA Survey and Activity Checklist.pdf 4 Teen Diet and Demographic Survey No No Printable Only Form and instruction Attach 4A-3 FLASHE Teenager Diet and Demographics Survey.doc 1 FLASHE Screener No No Printable Only Form and instruction Attach 4F Screener.docx 5 Teen Physical Activity Survey and Recall No No Printable Only Form and instruction Attach 4A-4 FLASHE Teenager PA Survey and Activity Recall.pdf 6 Parent Cognitive Interview Guide No No Printable Only Form and instruction Attach 4B-1 and 4B-2 Parent Cognitive Interview Guide.docx
Individuals or Households 80 63 0

Sub-study #5: Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of Cycle 3 Instrument No Health Consumer Health and Safety
1 Screener (English) Yes No Printable Only Form and instruction Attach E-1_Screener English.docx 2 Screener (Spanish) No No Printable Only Form and instruction Attach E-2_Screener Spanish.docx 3 Interview Protocol (English) No No Printable Only Form and instruction Attach B-1_Interview Protocol in English.docx 4 Interview Protocol (Spanish) No No Printable Only Form and instruction Attach B-2_Interview Protocol in Spanish.docx
Individuals or Households 93 65 0

Sub-study #7_Survey Instrument Designed to Assess Users' Perceptions of Website Changes No Health Consumer Health and Safety
1 ARP Website Survey Yes Yes Fillable Fileable Form and instruction Attachment 1_ARP Screenshots_survey.docx
Individuals or Households 100 5 0

Sub-study #6_Resubmission of Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of HINTS-FDA Instrument No Health Consumer Health and Safety
3 English Cognitive Interview Script No No Printable Only Form and instruction Attach B-1_Protocol English.docx 4 Spanish Cognitive Interview Script No No Printable Only Form and instruction Attach B-2_Protocol Spanish.docx 2 Spanish Screener No No Printable Only Form and instruction Attach E-2_Screener Spanish.docx 1 English Screener No No Printable Only Form and instruction Attach E-1_Screener English-rev2.docx
Individuals or Households 95 58 0

Sub-study #7_Development of Consensus Measures of Distress for the Grid Enabled Measures-Distress Measurement (GEM-DM) Workspace No Health Consumer Health and Safety
1 GEM-DM Survey Yes Yes Fillable Fileable Form and instruction Attachment A_GEM-DM Survey 8-27-2013.doc
Individuals or Households 100 25 0

2013-03-04-05:00

0925-0590 201107-0925-005 0925
             
        "National Children's Study Formative Generic Clearance"
             
          
        
The National Children's Study is a multi-center longitudinal study that will enroll a nationally representative sample of approximately 100,000 children born in the U.S. This is a request for programmatic clearance of formative research to help develop instruments, materials, and procedures for the NCS. These activities will be conducted to improve the efficiency of data collection and to decrease participant burden throughout the course of the Study. 2014-09-30-04:00 Active Saleda Perryman No No No 63000 90000 0

Methods to Enhance Child Assent Practices (for Parents and Children) No Health Health Care Services
Yes Yes Paper Only Instruction A.7 LOI3-INF-04-A Child Parent Interviews.docx Yes Yes Paper Only Instruction A.6 LOI3-INF-04-A Focus Group Questions for Parents.docx 1.1 Contact Information Form Yes Yes Fillable Printable Form A.3 LOI3-INF-04-A Contact Information Form.docx
Individuals or Households 385 272 0

2011-09-01-04:00

0925-0593 201211-0925-001 0925
             
        "Provider-Based Sampling Feasibility Study for the Vanguard (Pilot) Study and Data Collection Updates for the National Children's Study (NICHD)"
             
          
        
The National Children's Study is an integrated system of activities that includes a Vanguard (Pilot) Study for operations and methods development, and an NCS Main Study to collect data on exposure and response. The Vanguard (Pilot) Study, which includes the Initial Vanguard Study, the Alternate Recruitment Substudy (Phases 1 and 2), and the Provider-Based Sampling Feasibility Study (proposed in this information collection request), is currently underway. The Main Study is expected to follow within the next year. This request for revision includes (1) the addition of a Provider-Based Sampling Feasibility Study, and (2) supplemental measures for the Alternate Recruitment Substudy involving revised study visit assessments, physical measurements, and additional biospecimen collections. These information collections, revisions of instruments, physical measure implementation, and biospecimen collections will evaluate the feasibility, acceptability, and cost of study design elements to inform the Main Study. 2014-08-31-04:00 Active Mikia Currie 3014350941 No No No 55748 22791 0

Biological and Environmental Sample Collection (Prenatal) (PB, EH, TT-HI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
10.3 Survey Yes Yes Fillable Printable Form and instruction TWQ Participant Collect SAQ 20120413.docx 10.4 Survey Yes Yes Fillable Printable Form and instruction VBD Participant Collect SAQ 20120413.docx 10.2 Survey Yes Yes Fillable Printable Form and instruction TWF Participant Collect SAQ 20120413.docx 10.6 Survey Yes Yes Paper Only Form and instruction Attach B20. Biospecimen Adult Urine Instrument.docx 10.5 Survey Yes Yes Paper Only Form and instruction Attach B19. Biospecimen Adult Blood Instrument.docx
Individuals or Households 2912 2912 0

Low-Intensity Questionnaire (Found Pregnant) (TT-LI) No General Science and Innovation Scientific and Technological Research and Innovation
7.1 Survey Yes Yes Paper Only Form and instruction Low-Intensity Questionnaire (Non- & Pregnant) 20110211.docx
Individuals or Households 173 43 0

Validation Interview - up to 30 months (PB, EH, TT-HI, TT-LI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
4.1 Survey Yes Yes Paper Only Form and instruction Attach A15. Validation Instrument.docx
Individuals or Households 1268 106 0

Pregnancy Visit 1 Interview (PB, EH, TT-HI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
8.1 Survey Yes Yes Paper Only Form and instruction Attach A12. Pregnancy Visit 1 Interview.docx 8.2 Survey Yes Yes Fillable Printable Form and instruction Attach A14. Pregnancy Visit 1 SAQ.docx 8.4 Survey Yes Yes Fillable Printable Form and instruction Attach A2. PLSND Follow-Up SAQ.docx 8.3 Survey Yes Yes Paper Only Form and instruction Attach A1. PLSND Interview.docx
Individuals or Households 2018 1177 0

Pregnancy Visit 2 Interview (PB, EH, TT-HI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
9.1 Survey Yes Yes Paper Only Form and instruction Attach A13. Pregnancy Visit 2 Interview.docx 9.2 Survey Yes Yes Paper Only Form and instruction Pregnancy Visit 2 SAQ 20120413.docx
Individuals or Households 1817 757 0

Pregnancy Health Care Log (PB, EH, TT-HI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
11.1 Log Yes Yes Fillable Printable Form and instruction Pregnancy Health Care Log 20120413.docx
Individuals or Households 1615 538 0

Father Interview (PB, EH, TT-HI) No General Science and Innovation Scientific and Technological Research and Innovation
12.1 Survey Yes Yes Paper Only Form and instruction Father Interview 20120413.docx
Individuals or Households 818 477 0

Birth Visit Interview (PB, EH, TT-HI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
13.1 Survey Yes Yes Paper Only Form and instruction Birth Visit Interview 20120413.docx
Individuals or Households 1141 380 0

Low-Intensity Questionnaire (Birth focus) (TT-LI) No General Science and Innovation Scientific and Technological Research and Innovation
14.1 Survey Yes Yes Paper Only Form and instruction Low Intensity Birth Visit Interview 20120413.docx
Individuals or Households 432 108 0

Infant Feeding Log (PB, EH, TT-HI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
15.1 Log Yes Yes Fillable Printable Form and instruction Infant and Child Health Care Log 20120413.docx
Individuals or Households 1106 369 0

3-Month Interview (PB, EH, TT-HI, TT-LI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
24.1 Survey Yes Yes Paper Only Form and instruction 3-Month Mother Phone Interview 20110211.docx
Individuals or Households 1518 506 0

6-Month Interview (PB, EH, TT-HI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
18.2 Survey Yes Yes Paper Only Form and instruction 6-Month Infant Feeding SAQ 20120413.docx 18.1 Survey Yes Yes Paper Only Form and instruction 6-Month Interview 20120413.docx
Individuals or Households 1066 533 0

9-Month Interview (PB, EH, TT-HI, TT-LI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
21.1 Survey Yes Yes Paper Only Form and instruction 9-Month Mother Interview 20120413.docx
Individuals or Households 1428 238 0

12-Month Interview (PB, EH, TT-HI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
22.3 Survey - Placeholder for Copyrighted Material Yes Yes Paper Only Form and instruction Brief Infant Toddler Social Emotional Assessment (BITSEA) SAQ.docx 22.2 Survey Yes Yes Paper Only Form and instruction 12-Month Mother SAQ.docx 22.1 Survey Yes Yes Paper Only Form and instruction 12-Month Mother Interview 20120413.docx
Individuals or Households 1003 836 0

18-Month Interview (PB, EH, TT-HI, TT-LI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
23.5 Survey - Placeholder for copyrighted material Yes Yes Paper Only Form and instruction 20 MO ASQ-3.docx 23.6 Survey - Placeholder for copyrighted material Yes Yes Paper Only Form and instruction 22 MO ASQ-3.docx 23.1 Survey Yes Yes Paper Only Form and instruction 18-Month Interview 20120413.docx 23.4 Survey - Placeholder for copyrighted material Yes Yes Paper Only Form and instruction 18 MO ASQ-3.docx 23.2 Survey - Placeholder for copyrighted material Yes Yes Paper Only Form and instruction 14 MO ASQ-3.docx 23.3 Survey - Placeholder for copyrighted material Yes Yes Paper Only Form and instruction 16 MO ASQ-3.docx
Individuals or Households 1316 658 0

24-Month Interview (PB, EH, TT-HI, TT-LI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
24.3 Survey - Placeholder for copyrighted material Yes Yes Paper Only Form and instruction 24 MO ASQ-3.docx 24.4 Survey - Placeholder for copyrighted material Yes Yes Paper Only Form and instruction 27 MO ASQ-3.docx 24.5 Survey - Placeholder for copyrighted material Yes Yes Paper Only Form and instruction 30 MO ASQ-3.docx 24.2 Survey Yes Yes Paper Only Form and instruction Modified Checklist for Autism in Toddlers SAQ 20120413.docx 24.1 Survey Yes Yes Paper Only Form and instruction 24 MO Interview 20120413.docx
Individuals or Households 1251 730 0

Formative - Developmental No General Science and Innovation Scientific and Technological Research and Innovation
Yes Yes Paper Only Instruction Burden 90 Food Record 20110621 - LOI2-QUEX-14.docx Yes Yes Paper Only Instruction Burden 250 Measurement Form 20110621 - LOI3-PHYS-02.pdf Yes Yes Paper Only Instruction Burden 125 Exemplar Demographics 20110621 - LOI3-PHYS-02.docx Yes Yes Paper Only Instruction Burden 20 Participant Internet Usage and Contact Preference Survey 20110420 - LOI2-INF-17.docx Yes Yes Paper Only Instruction Burden 19 HiLo Household Inventory Questionnaire 20110420 - LOIx-QUEX-01-B-1.DOCX Yes Yes Paper Only Instruction Attach B4. LOI2-QUEX-14 ASA24 Instructions.pdf 17.7 Survey Yes Yes Fillable Printable Form and instruction Attach B12. LOI2-QUEX-14 Child Food Questionnaire.pdf 17.11 Survey Yes Yes Paper Only Form and instruction Attach B23. Biospecimen Placenta and Umbilical Cord Data Collection.docx 17.10 Survey Yes Yes Paper Only Form and instruction Attach B22. Biospecimen Cord Blood Instrument.docx 17.9 Survey Yes Yes Paper Only Form and instruction Attach B21. Biospecimen Infant Blood Spot Instrument.docx Yes Yes Paper Only Instruction Burden 38 Initial Acceptability Questionnaire 20110621 - LOI2-QUEX-14.doc Yes Yes Paper Only Instruction Burden 37 Second Acceptability Questionnaire 20110621 - LOI2-QUEX-14.doc Yes Yes Paper Only Instruction Burden 15 Acculturation Instrument 20110621 - LOI2-QUEX-14.docx Yes Yes Paper Only Instruction Burden 75 Questionnaire 20110621 - LOI3-PHYS-01.docx Yes Yes Paper Only Instruction Burden 38 Visit Screen 20110621 - LOI3-PHYS-01.docx Yes Yes Paper Only Instruction Burden 38 Exit Survey 20110621 - LOI3-PHYS-01.docx Yes Yes Paper Only Instruction Burden 38 Contact Info 20110621 - LOI3-PHYS-01.docx 17.8 Survey Yes Yes Paper Only Form and instruction Attach B16. LOI2-QUEX-14 Recruitment Screener.pdf none Attach B25. Participant Verification Birth Cohort Yes Yes Paper Only Form and instruction Attach B25. Participant Verification Birth Cohort.docx Yes Yes Paper Only Other Note to File - Formative Research (updated 20130204).docx 17.6 Survey Yes Yes Paper Only Form and instruction Attach B11. LOI2-QUEX-14 Infant Feeding Questionniare.pdf 17.5 Survey Yes Yes Fillable Printable Form and instruction Attach B10. LOI2-QUEX-14 Child Acceptability Questionnaire #2.doc 17.4 Survey Yes Yes Fillable Printable Form and instruction Attach B9. LOI2-QUEX-14 Child Acceptability Questionnaire #1.doc 17.3 Survey Yes Yes Fillable Printable Form and instruction Attach B8. LOI2-QUEX-14 Infant Acceptability Questionnaire #2.doc 17.2 Survey Yes Yes Fillable Printable Form and instruction Attach B7. LOI2-QUEX-14 Infant Acceptability Questionnaire #1.doc Yes Yes Paper Only Instruction Attach B6. LOI2-QUEX-14 Food Diary Instructions-Parent.doc Yes Yes Paper Only Instruction Attach B5. LOI2-QUEX-14 ASA24 Protocol.docx 17.1 Survey Yes Yes Paper Only Form and instruction Attach B3. LOI2-QUEX-14 SocioDemographics.docx Yes Yes Paper Only Instruction Burden 225 B.2.4 LOI2-PHYS-15 Exemplar Participant Experience Survey.docx Yes Yes Paper Only Instruction Burden 900 B.1.7 LOI3-BIO-02 Exemplar Interview.docx Yes Yes Paper Only Instruction Burden 900 B.1.2 LOI3-BIO-02 Exemplar Screening Interview.docx Yes Yes Paper Only Instruction Burden 250 NCS ASA24 Protocol (Placeholder for web survey) 20110621 - LOI2-QUEX-14.docx Yes Yes Paper Only Instruction Burden 38 Screening 20110621 - LOI3-PHYS-01.docx Yes Yes Paper Only Instruction Burden 100 NCS FFQ 20110621 - LOI2-QUEX-14.pdf
Individuals or Households 4847 4847 0

Provider-Based Sampling Eligibility Screener (PBS) No General Science and Innovation Scientific and Technological Research and Innovation
1.1 Survey Yes Yes Paper Only Form and instruction Provider Based Sampling Eligibility Screener 20120413.docx
Individuals or Households 3125 1042 0

Provider-Based Sampling Frame Questionnaire (PBS) No General Science and Innovation Scientific and Technological Research and Innovation
2.2 Survey Yes Yes Fillable Printable Form and instruction Provider Based Sampling Frame Questionnaire Jefferson Co 20120413.docx 2.3 Survey Yes Yes Fillable Printable Form and instruction Provider Based Sampling Frame Questionnaire Worcester Co 20120413.docx 2.1 Survey Yes Yes Fillable Printable Form and instruction Provider Based Sampling Frame Questionnaire Harris Co 20120413.docx 2.4 Survey Yes Yes Paper Only Form and instruction PBS Recruitment Response Form 20120413.docx
Individuals or Households 50 21 0

Nonrespondent Questionnaire (PB, EH, TT-HI, TT-LI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
3.1 Survey Yes Yes Paper Only Form and instruction Nonrespondent Questionnaire 20120413.docx
Individuals or Households 480 40 0

Participant Verification (PB, EH, TT-HI, TT-HI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
5.1 Survey Yes Yes Paper Only Form and instruction Participant Verification Questionnaire 20120413.docx
Individuals or Households 2320 193 0

Tracing Interview (PB, EH, TT-HI, TT-LI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
6.1 Survey Yes Yes Paper Only Form and instruction Attach A16. Tracing Interview.docx
Individuals or Households 15171 2529 0

Biospecimen Sample Collection - Mother / Baby (PB, EH, TT-LI) No General Science and Innovation Scientific and Technological Research and Innovation
16.3 Survey Yes Yes Paper Only Form and instruction 12 MO Child Blood Instrument 20120413.docx 16.4 Survey Yes Yes Paper Only Form and instruction 12 MO Child Saliva Instrument 20120413.docx 16.2 Survey Yes Yes Paper Only Form and instruction 6, 12 MO Child Urine Collection Instrument 20120413.docx 16.5 Survey Yes Yes Fillable Printable Form and instruction 12 MO Child Saliva SAQ 20120413.docx 16.1 Survey Yes Yes Fillable Printable Form and instruction 1, 3 MO Breast Milk Collection SAQ 20120413.docx
Individuals or Households 3044 1142 0

Physical Measures - Child Anthropometry (6-,12-,24-Month) (PB, EH, TT-HI) No General Science and Innovation Scientific and Technological Research and Innovation
19.1 Survey Yes Yes Paper Only Form and instruction 6, 12, 24 MO Child Anthropometry Instrument 20120413.docx
Individuals or Households 2103 701 0

Physical Measures - Child Blood Pressure (12-,24-Month) (PB, EH, TT-HI) No General Science and Innovation Scientific and Technological Research and Innovation
20.1 Survey Yes Yes Paper Only Form and instruction 12, 24 MO Child Blood Pressure Instrument 20120413.docx
Individuals or Households 1350 225 0

Core Questionnaire (PB, EH, TT-HI, TT-LI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
25.1 Survey Yes Yes Paper Only Form and instruction Core Questionnare 20120413.docx
Individuals or Households 1188 594 0

30-Month Interview (PB, EH, TT-HI, TT-LI, PBS) No General Science and Innovation Scientific and Technological Research and Innovation
26.3 Survey - Placeholder for copyrighted material Yes Yes Fillable Printable Form and instruction Brief Symptom Index SAQ.docx 26.4 Survey - Placeholder for copyrighted material Yes Yes Fillable Printable Form and instruction Infant & Toddler Sensory Profile SAQ.docx 26.2 Survey Yes Yes Fillable Printable Form and instruction Brief Infant Toddler Social Emotional Assessment (BITSEA) SAQ.docx 26.1 Survey Yes Yes Paper Only Form and instruction 30 MO Interview 20120413.docx
Individuals or Households 1188 1089 0

2013-03-09-05:00

0925-0597 201303-0925-003 0925
             
        "The Prevalence and Incidence of HIV Molecular Variants and Their Correlation with Risk Behaviors and HIV Treatment in Brazilian Blood Donors (NHLBI)"
             
          
        
The purpose of the interview questions is to collect donor profile data for comparing risk exposures between prospective blood donors who test HIV positive (cases) and HIV negative (controls). The responses will permit us to determine risk factors associated with HIV infection among volunteer replacement blood donors in Brazil. A case control study will yield interview data on HIV risk behaviors among prospective donors that will be used; 1) to understand predominant risk behaviors associated with in HIV positive blood donation in Brazil, for example: male-to-male sex, having multiple heterosexual partners, and to a lesser extent injection drug use (IDU), 2) the results may also lead to suggestions for modification to current operational donor screening questionnaire in ways that can decrease risk and improve blood safety. The questions for both cases and controls are identical, except for five additional questions that will be asked at the end of the interview on topics that are unique for HIV positive individuals (cases). 2015-07-31-04:00 Active Saleda Perryman No No No 100 40 0

HIV Case Control Study No Health Immunization Management
1 Questionnaire Yes Yes Fillable Fileable Form and instruction Attach_1_Brazil_HIV_Case_Study_Questionnaire_4_26_2012_V_7 0.docx
Individuals or Households 100 40 0

2013-03-20-04:00

0925-0600 201304-0925-002 0925
             
        "The Clinical Trials Reporting Program (CTRP) Database (NCI)"
             
          
        
The Clinical Trials Reporting Program (CTRP) is an electronic resource that serves as a single, definitive source of information about all NCI-supported clinical research. This resource allows the NCI to consolidate reporting, aggregate information and reduce redundant submissions. Information is submitted by clinical research administrators as designees of clinical investigators who conduct NCI-supported clinical research. The designees can electronically access the CTRP website to complete the initial trial registration for each protocol. Subsequent to registration, up to four amendments and four study subject accrual updates occur per protocol annually. 2016-05-31-04:00 Active Saleda Perryman No No No 49500 33000 0

Registration for the Clinical Trials Reporting Program (CTRP) Database (NCI) No Health Public Health Monitoring
1 CTRP Registration Abbreviated Participating Sites Template Yes Yes Fillable Fileable Form and instruction Attach_5D_CTRP_Registry_Abbreviated_Batch_Upload_Template.xls 1 CTRP Registration Complete Participating Sites Template Yes Yes Fillable Fileable Form and instruction Attach_5B_CTRP_Registry_Complete_Trial_Participating_Sites_Template.xls 1 CTRP Registration Complete Batch Template Yes Yes Fillable Fileable Form and instruction Attach_5A_CTRP_Registry_Complete_Batch_Template.xls 1 CTRP Registration Batch Upload Template Yes Yes Fillable Fileable Form and instruction Attach_5C_CTRP_Registry_Abbreviated_Participating_Sites_Template.xls
Individuals or Households 5500 5500 0

Amendment for the Clinical Trials Reporting Program (CTRP) Database (NCI) No Health Public Health Monitoring
2 Screenshots of Registration, Update/Amendment, and Accrual Yes Yes Fillable Fileable Form and instruction Attach_3_NCI CTRP Screen Shots.DOC
Individuals or Households 22000 22000 0

NCI CTRP Accrual Portal Workflow and Screen Shots No Health Public Health Monitoring
3 CTRP Accrual Batch File Tool Yes Yes Fillable Fileable Form and instruction Attach_5E_CTRP_Accrual Batch File Tool.xlsm 3 CTRP Accural Updates Yes Yes Fillable Fileable Form Attachment_2C_FORM_CTRP Accruals.doc
Individuals or Households 22000 5500 0

2013-05-22-04:00

0925-0601 201304-0925-005 0925
             
        "Human Embryonic Stem Cell Line "
             
          
        
President Barack H. Obama issued Executive Order (EO)13505 Removing Barriers to Responsible Scientific Research Involving Human Stem Cells on March 9, 2009. The EO states that the Secretary of Health and Human Services, through the Director of NIH, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law. The EO also directs the Secretary, through the Director of NIH, to review existing NIH guidance and other widely recognized guidelines on human stem cell research, including provisions establishing appropriate safeguards, and issue new NIH Guidelines on such research. The NIH Guidelines for Human Stem Cell Research (Guidelines) implementing the EO and establishing policy and procedures under which the NIH will fund such research became effective on July 7, 2009, and are available at http://stemcells.nih.gov/index.asp. The Guidelines provide scientists who apply for NIH funding with a specific set of standards reflecting currently recognized ethical principles and practices specific to embryo donation, and prescribe the assurances and supporting documentation necessary for NIH funding of research using hESCs, and describe research that is not eligible for NIH funding. The Guidelines establish a new NIH Registry of eligible hESC lines that comply with the set of standards described in the Guidelines. NIH will also post lines that are not approved for use in NIH funding. 2016-05-31-04:00 Active Mikia Currie 3014350941 No No No 150 2550 0

Form 2890-Stem Cell No Health Health Care Services
Yes Yes Printable Only Instruction Attachment 2 Instructions NIH Form 2890.pdf 1 NIH 2890 Yes Yes Fillable Fileable Form Attachment 1 NIH Form 2890.pdf
Private Sector 150 2550 0

2013-05-29-04:00

0925-0602 201309-0925-006 0925
             
        "Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research"
             
          
        
This study will assess the value of the training programs administered by the Office of Clinical Research Training and Medical Education. The primary objective of the survey is to determine if training programs have had an impact on whether the trainees are performing clinical research, hold an academic appointment, have National Institutes of Health funding sources as well as to obtain information from the trainees as to what part of the National Institutes of Health medical education program they feel could be improved upon, the quality of the mentoring program, and how their National Institutes of Health training has contributed to their current clinical competence. Frequency of response: On occasion. Affected Public: Physicians, dentists, medical students, dental students, nurses, and PhDs. 2016-03-31-04:00 Active Saleda Perryman No No No 785 261 0

Doctors No Health Health Care Services
1 IPPCR Yes Yes Fillable Fileable Form and instruction IPPCR 12 Month Survey Screenshots.pdf 2 PCP Yes Yes Fillable Fileable Form and instruction PCP Alumni Survey 1yr Screenshots.pdf 4 REP Yes Yes Fillable Fileable Form and instruction Resident Elective Participant Survey.pdf 5 NIH Duke Training Program in Clinical Research Yes Yes Fillable Fileable Form and instruction NIH-Duke Program Alumni Survey.pdf 3 GME Yes Yes Fillable Fileable Form and instruction GME Alumni Survey Screen Shots.pdf
Individuals or Households 354 118 0

Students No Health Health Care Services
1 IPPCR Yes Yes Fillable Fileable Form and instruction IPPCR 12 Month Survey Screenshots.pdf 2 PCP Yes Yes Fillable Fileable Form and instruction PCP Alumni Survey 1yr Screenshots.pdf 4 CEP Yes Yes Fillable Fileable Form and instruction Clinical Electives Program Alumni Survey-Screen Shots.pdf 5 Ph.D Student Summer Course in Clinical and Translational Research Yes Yes Fillable Fileable Form and instruction PhD Student Summer Course 1 Year Followup Survey.pdf 6 Summer Research Program Yes Yes Fillable Fileable Form and instruction Summer Internship Program Alumni Survey.pdf 3 MSRP CRTP Yes Yes Fillable Fileable Form and instruction MRSP-CRTP Alumni Survey-Screen Shots[1].pdf
Individuals or Households 403 134 0

Others (administrators, nurses etc.) No Health Health Care Services
1 Sabbatical in Clinical research Management Yes Yes Fillable Fileable Form and instruction Sabbatical 1 Year Followup Survey.pdf
Individuals or Households 28 9 0

2013-09-23-04:00

0925-0605 201107-0925-003 0925
             
        "Food Reporting Comparison Study (FORCS) and Food and Eating Assessment Study (FEAST) (NCI)"
             
          
        
Currently, the interviewer-administered 24-hour dietary recall (24HR) is considered the best dietary data collection methodology. It provides the highest quality and least biased food intake data for a single day (past 24 hours). The newly developed web-based Automated Self-Administered 24-hour Recall (ASA24) transforms 24HR methodology into a convenient, self-administered, low-cost method of collecting dietary intake data. Because it is web-based, self-administered, and uses 24HR methodology, the ASA24 makes it feasible to collect multiple days of dietary intake data in large-scale studies. The web-based, automated data collection system also offers the advantage of automated coding of food items and calculation of nutrient intakes. A single day of 24HR data will be collected from a sample of eligible participants either once or twice within a six week period using the ASA24 and the AMPM. Dietary intake from the new ASA24 method will be compared to dietary intake data from the standard AMPM method. The findings from this study will provide information on the feasibility and validity of the ASA24 relative to the standard AMPM methodology. The ASA24 method would offer a low-cost alternative to the AMPM method, and thus could allow a wider use of 24HR methodology within existing resources. 2014-02-28-05:00 Active Saleda Perryman No No No 4255 867 0

24HR Recall Comparison Study Screenshots of Information and Consent No Health Public Health Monitoring
1 Comparison Study Screenshot Information and Consent Yes Yes Fillable Fileable Form and instruction Attach2 - 24HR comparison screenshots information and consent.doc
Individuals or Households 0 0 0

Screener FORCS No Health Consumer Health and Safety
2 Screener Questionnaire Yes No Fillable Printable Form and instruction Attach 5 - FORCS telephone screening script 11-0330.docx
Individuals or Households 400 33 0

Automated Multiple Pass Method (AMPM) for FORCS No Health Consumer Health and Safety
3 Automated Multiple Pass Method (AMPM) http://www.ars.usda.gov/Services/docs.htm?docid=7710 Yes Yes Fillable Fileable Form and instruction Attach 1 - AMPM Screenshots.11-0330.docx
Individuals or Households 400 200 0

Automated Self-Administered 24-hour Recall (ASA24) for FORCS No Health Consumer Health and Safety
4 Automated Self-Administered 24-hour Recall (ASA24) http://asa24.westat.com/ Yes Yes Fillable Fileable Form and instruction Attach 2 - ASA24 Screenshots 11-0330.docx
Individuals or Households 400 200 0

Demographic and Health Questionnaire for FORCS No Health Consumer Health and Safety
5 Demographic and Health Questionnaire Yes Yes Fillable Fileable Form and instruction Attach 6 - FORCS demographic and health questionnaire 11-0330.docx
Individuals or Households 360 60 0

Demographic, Health and Preference Qx for FORCS No Health Consumer Health and Safety
6 Demographic, Health and Preference Qx Yes Yes Fillable Fileable Form and instruction Attach 7 - FORCS Demo health and Pref Questionnaire 11-0330.docx
Individuals or Households 360 90 0

Screener for FEAST No Health Consumer Health and Safety
7 Screener Questionnaire for FEAST Yes No Fillable Printable Form and instruction Attach 8 - FEAST screening script 11-0330.docx
Individuals or Households 33 3 0

Reminder Telephone Call for FEAST No Health Consumer Health and Safety
8 Reminder Telephone Call Yes No Printable Only Form and instruction Attach 10 - FEAST reminder script 11-0330.docx
Individuals or Households 33 3 0

Eating 3 Meals for FEAST No Health Consumer Health and Safety Individuals or Households 33 74 0

AMPM or ASA24 Dietary Recall for FEAST No Health Consumer Health and Safety
10a AMPM Yes Yes Fillable Fileable Form and instruction Attach 1 - AMPM Screenshots.11-0330.docx 10b ASA24 Yes Yes Fillable Fileable Form and instruction Attach 2 - ASA24 Screenshots 11-0330.docx
Individuals or Households 33 17 0

Demographic & Health Questionnaire for FEAST No Health Consumer Health and Safety
12 Demographic & Health Questionnaire Yes Yes Fillable Fileable Form and instruction Attach 12 - FEAST health-pref quex 11-0330.docx
Individuals or Households 33 6 0

Refusal Reasons and Demographics for FORCS No Health Consumer Health and Safety
12 Att. 4A_Refusal Reasons and Demographics Yes Yes Fillable Fileable Form and instruction Attach 4 - FORCS screen shots 11-0330.docx
Individuals or Households 1770 148 0

Contact Information for FORCS No Health Consumer Health and Safety
13 Contact Information (Screen 5) Yes Yes Fillable Fileable Form and instruction Attach 4 - FORCS screen shots 11-0330.docx
Individuals or Households 400 33 0

2011-08-01-04:00

0925-0610 201211-0925-007 0925
             
        "NEXT Generation Health Study - NICHD"
             
          
        
The purpose of this OMB application is to permit continued collection of longitudinal health behavior and health status data in this cohort of U.S. adolescents for four more years. In addition, up to six best friends nominated by the NEXT Plus cohort in 2013 and 2015 will complete brief surveys of their health behaviors. This is a revision of the previous application because there is a new group of respondents and a revision of the survey forms 2016-04-30-04:00 Active Saleda Perryman No No No 4635 3790 0

Young Adults No Health Public Health Monitoring
No No Paper Only Instruction Attachment 7 Physical Activity Recall 2012.doc 1 Participant Online Survey Yes Yes Fillable Fileable Form and instruction Attachment 1B - Participant Online Survey Screenshots.pdf
Individuals or Households 2100 2100 0

Adolescents with Additional Assesments No Health Public Health Monitoring
9 survey Yes Yes Paper Only Form and instruction Attach 9 10 survey Yes Yes Paper Only Form and instruction Attach 10
Individuals or Households 0 0 0

Parents No Health Public Health Monitoring
8 Parent In-Home Survey Yes Yes Paper Only Form and instruction Attach 8.pdf
Individuals or Households 0 0 0

School Administrators No Health Public Health Monitoring
2 Administrator Survey Yes Yes Paper Only Form and instruction Attach 2.pdf
Individuals or Households 0 0 0

Peers recruited No Health Public Health Monitoring
2 Peer Online Survey Yes Yes Fillable Fileable Form and instruction Attachment 2B Peer Online Survey Screen Shots.doc
Individuals or Households 2535 1690 0

2013-04-03-04:00

0925-0612 201306-0925-008 0925
             
        "NLM Lost People-Finder System"
             
          
        
The LPF was developed by NLM for possible future use by BHEPP during emergencies in the National Capitol Region. BHEPP was established to improve community disaster preparedness and response in Bethesda, Maryland and includes the National Naval Medical Center, the National Institutes of Health Clinical Center, and Suburban Hospital/Johns Hopkins Medicine. Multi-agency exercises identified a need for a tool to help reunify families during a crisis, in particular as disaster victims are brought to medical facilities for care. The LPF system is designed to allow first responders to submit photographs and descriptive information about disaster victims (name (if known), age group, gender, status, and location) to a Web site that other family members can search to locate loved ones. The system has been designed to share data with other lost-person finder systems, including the system established by Google, but it provides additional functionality not available in these other systems, including the capability to upload photographs from camera-equipped cell phones and to search by information other than name. 2016-07-31-04:00 Active Saleda Perryman No No No 150000 7500 0

Emergency Care First-Responders, Physicians, Other Health Care Providers No Disaster Management Emergency Response
1 iPhone iPad Screenshots Yes Yes Fillable Fileable Form and instruction Attachment 2 Screenshot Information Ver 04-4-2013.pdf
Individuals or Households 50000 2500 0

Family Members No Disaster Management Emergency Response
1 iPhone iPad Screenshots Yes Yes Fillable Fileable Form and instruction Attachment 2 Screenshot Information Ver 04-4-2013.pdf
Individuals or Households 100000 5000 0

2013-07-31-04:00

0925-0613 201302-0925-005 0925
             
        "Investigator Registration and Financial Disclosure for Investigational Trials in Cancer Treatment (NCI)"
             
          
        
The U.S. Food and Drug Administration (FDA) holds the National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis/Cancer Therapy Evaluation Program (NCI/DCTD/CTEP) and the Division of Cancer Prevention (DCP) responsible, as a sponsor of investigational drug trials, for the collection of information about the clinical investigators who participate in these trials and to assure the FDA that systems for accountability are being maintained by investigators in its clinical trials program. The information collected is used to identify qualified investigators and to facilitate the submission and distribution of important information relative to the investigational drug and the response of the patient to that drug. Investigators are physicians who specialize in the treatment of patients with cancer. Data obtained from the Drug Accountability Record is used to track the dispensing of investigational anticancer agents from receipt from the NCI to dispensing or administration to patients. NCI and/or its auditors use this information for compliance purposes. 2016-03-31-04:00 Active Saleda Perryman No No No 123724 14328 0

Statement of Investigator (Attachment 3A, 3B or 10) No Health Health Care Services
2 Statement of Investigator DCP Yes Yes Fillable Fileable Form and instruction Attach_3B_Statement of Investigator_DCP.pdf 3 Statement of Investigator Online Yes Yes Fillable Fileable Form Attach_10_NCI OCR Screen Shots.pdf 1 Statement of Investigator CTEP No No Printable Only Form and instruction Attach_3A_Statement of Investigator_CTEP.pdf
Individuals or Households 20200 5050 0

Supplemental Investigator Data Form (Attachment 4) No Health Health Care Services
4 Supplemental Investigator Data Form No No Printable Only Form and instruction Attach_4_Supplemental_Investigator_Data_Form.pdf
Individuals or Households 20112 3352 0

Financial Disclosure Form (Attachments 5A or 5B) No Health Health Care Services
5 Financial Disclosure Form_CTEP No No Printable Only Form and instruction Attach_5A_Financial_Disclosure_CTEP.pdf 6 Financial Disclosure Form_DCP Yes Yes Fillable Fileable Form and instruction Attach_5B-Financial Disclosure_DCP.pdf
Individuals or Households 20800 1733 0

Electronic Curriculum Vitae (Attachment 11) No Health Health Care Services
7 CV Yes Yes Fillable Fileable Form and instruction Attach_11_NCI_OCR_CV.pdf
Individuals or Households 100 25 0

Drug Accountability Record Form (DARF and DARF-Oral) No Health Health Care Services
9 Drug Accountability Record Form_Oral Yes Yes Fillable Fileable Form and instruction Attach_2_DARF Oral Form.pdf 8 Drug Accountability Record Form Yes Yes Fillable Fileable Form and instruction Attach_1_DARF Form.pdf
Individuals or Households 62512 4168 0

2013-03-25-04:00

0925-0616 201203-0925-002 0925
             
        "STAR METRICS (OD)"
             
          
        
The Office of Science and Technology Policy, through the NSTC Committee on Science, established the Science of Science Policy (SoSP) Interagency Working Group to develop an evidence-based framework for informing policy investments in research and development, and assess the impacts of those investments broadly. Themes and goals for this emergent research field were outlined in a Federal Research Roadmap , and this effort was also highlighted in the FY 2011 Budget Priorities Memorandum from OSTP and the Office of Management and Budget (OMB). The memorandum asks Federal agencies to "develop outcome-oriented goals for their science and technology activities, establish procedures and timelines for evaluating the performance of these activities, and target investments toward high-performing programs. Agencies should develop 'science of science policy' tools that can improve management of their research and development portfolios and better assess the impact of their science and technology investments. Sound science should inform policy decisions, and agencies should invest in relevant science and technology as appropriate." The initial goal of STAR METRICS is to provide mechanisms that furnish participating universities and federal agencies with a reliable and consistent means to account for the number of scientists and staff that are on research institution payrolls, supported by federal funds. 2015-03-31-04:00 Active Saleda Perryman Yes No No 407 1315 0

Universities/Applicants No General Science and Innovation Scientific and Technological Research and Innovation
1 Database Yes Yes Fillable Fileable Form and instruction Attachment 7_Star Metrics website screenshot.pdf
Private Sector 7 315 0

University/Applications No General Science and Innovation Scientific and Technological Research and Innovation
1 Database Yes Yes Fillable Fileable Form and instruction Attachment 7_Star Metrics website screenshot.pdf
Private Sector 400 1000 0

2012-03-09-05:00

0925-0624 201312-0925-003 0925
             
        "Cancer Trials Support Unit (CTSU)  Public Use Forms and Customer Satisfaction Surveys (NCI)"
             
          
        
The Cancer Therapy Evaluation Program (CTEP) establishes and supports programs to facilitate the participation of qualified investigators on CTEP-supported studies, and to institute programs that minimize redundancy among grant and contract holders, thereby reducing overall cost of maintaining a robust treatment trials program. Currently guided by the efforts of the Clinical Trials Working Group (CTWG) and the Institute of Medicine (IOM) recommendations to revitalize the Cooperative Group program, CTEP has funded the Cancer Trials Support Unit (CTSU). The CTSU collects standardized forms to process site regulatory information, changes to membership, patient enrollment data, and routing information for case report forms. In addition, CTSU collects seven surveys used for customer satisfaction or related to clinical trials. The customer satisfaction surveys assess different areas of service delivery at CTSU including: the CTSU Help Desk, the CTSU web site, the Protocol and Information Office (PIO), and the Oncology Patient Enrollment Network (OPEN). User satisfaction surveys are compiled as part of the project quality assurance activities and are used to direct improvements to processes and technology. Additionally, there are three surveys collect information about health professional's interests in clinical trial, potential issues with opening and accruing to a clinical trial and reasons for low accrual. 2017-01-31-05:00 Active Saleda Perryman No No No 237560 25204 0

Attach 1A - CTSU IRB/Regulatory Approval Transmittal Form No Health Health Care Services
1 CTSU IRB/Regulatory Approval Transmittal Form Yes Yes Fillable Fileable Form and instruction attachment_1a_irbtrans.pdf
Individuals or Households 108000 3600 0

Attach 1B - CTSU IRB Certification Form No Health Health Care Services
2 CTSU IRB Certification Form Yes Yes Fillable Fileable Signable Form and instruction attachment_1b_irbcrt.pdf
Private Sector 102000 17000 0

Attach 1C- CTSU Acknowledgement Form No Health Health Care Services
3 CTSU Acknowledgement Form Yes Yes Fillable Fileable Signable Form and instruction attachment_1c_ctsuac.pdf
Individuals or Households 6000 500 0

Attach 1D - Optional Form 1 - Withdrawal from Protocol Participation Form No Health Health Care Services
4 Optional Form 1 - Withdrawal from Protocol Participation Yes Yes Fillable Fileable Signable Form and instruction attachment_1d_wd.pdf
Individuals or Households 600 50 0

Attach 1F - CTSU Roster Update Form No Health Health Care Services
6 CTSU Roster Update Form Yes No Fillable Fileable Form and instruction attachment_1f_ruf.pdf
Individuals or Households 600 40 0

Attach 1G - CTSU Radiation Therapy Facilities Inventory Form No Health Health Care Services
7 CTSU Radiation Therapy Facilities Inventory Form No No Fillable Printable Form and instruction attachment_1g_rtform.pdf
Private Sector 240 120 0

Attach 1H - CTSU IBCSG Drug Accountability Form No Health Health Care Services
8 CTSU IBCSG Drug Accountability Form No No Fillable Printable Form and instruction attachment_1h_ibcsgdrug.pdf
Private Sector 132 22 0

Attach 1I - CTSU IBCSG Transfer of Investigational Agent Form No Health Health Care Services
9 CTSU IBCSG Transfer of Investigational Agent Form No No Fillable Printable Form and instruction attachment_1i_ibcsgtr.pdf
Private Sector 36 12 0

Attach 1J - Site Initiated Data Update Form (generic) No Health Health Care Services
10 Site Initiated Data Update Form No No Fillable Printable Form and instruction attachment_1j_siteduf.pdf
Individuals or Households 120 20 0

Attach 1J - N0147 CTSU Data Transmittal Form No Health Health Care Services
10 Attach 1J - N0147 CTSU Data Transmittal Form Yes No Fillable Fileable Form and instruction attach_1j_n0147dtf.pdf
Private Sector 0 0 0

Attach 1K - Site Initiated Data Update Form (DUF), Protocol: NCCTG N0147 No Health Health Care Services
11 Attach 1K - Site Initiated Data Update Form (DUF), Protocol: NCCTG N0147 Yes No Fillable Fileable Form and instruction attach_1k_N0147duf.zip
Private Sector 0 0 0

Attach 1L - TAILORX/PACCT 1 CTSU Data Transmittal Form No Health Health Care Services
12 Attach 1L - TAILORX/PACCT 1 CTSU Data Transmittal Form Yes No Fillable Fileable Form and instruction attach_1l_Pacctdtf.zip
Private Sector 0 0 0

Attach 1K - Data Clarification Form No Health Health Care Services
11 Data Clarification Form No No Fillable Printable Form and instruction attachment_1k_dcf.pdf
Individuals or Households 4092 1364 0

Attach 1N - Unsolicited Data Modification Form (UDM), Protocol:TAILORx/PACCT1 No Health Health Care Services
14 Attach 1N - Unsolicited Data Modification Form (UDM), Protocol:TAILORx/PACCT1 Yes No Fillable Fileable Form and instruction attach_1n_pacudm.pdf
Private Sector 0 0 0

Attach 1O - Z4032 CTSU Data Transmittal Form No Health Health Care Services
15 Attach 1O - Z4032 CTSU Data Transmittal Form Yes No Fillable Fileable Form and instruction attach_1o_z4032_DTF.zip
Private Sector 0 0 0

Attach 1P - Z1031 CTSU Data Transmittal Form No Health Health Care Services
16 Attach 1P - Z1031 CTSU Data Transmittal Form Yes No Fillable Fileable Form and instruction attach_1p_1031dtf.zip
Private Sector 0 0 0

Attach 1Q - Z1041 CTSU Data Transmittal Form No Health Health Care Services
17 Attach 1Q - Z1041 CTSU Data Transmittal Form Yes No Fillable Printable Form and instruction attach_1q_1041dtf.zip
Private Sector 0 0 0

Attach 1R - Z6051 CTSU Data Transmittal Form No Health Health Care Services
18 Attach 1R - Z6051 CTSU Data Transmittal Form Yes No Fillable Printable Form and instruction attach_1r_6051dtf.zip
Private Sector 0 0 0

Attach 1L - RTOG 0834 CTSU Data Transmittal Form No Health Health Care Services
12 RTOG 0834 CTSU Data Transmittal Form No No Fillable Printable Form and instruction attachment_1l_rtog0834.pdf
Individuals or Households 720 120 0

Attach 1T - CTSU 7868 Data Transmittal Form No Health Health Care Services
20 Attach 1T - CTSU 7868 Data Transmittal Form Yes No Fillable Fileable Form and instruction attach_1t_7868dtf.zip
Private Sector 0 0 0

Attach 1U - Site Initiated Data Update Form, protocol 7868 No Health Health Care Services
21 Attach 1U - Site Initiated Data Update Form, protocol 7868 Yes No Fillable Printable Form and instruction attach_1u_7868duf.zip
Private Sector 0 0 0

Attach 1M - MC0845(8233) CTSU Data Transmittal No Health Health Care Services
13 MC0845 (8233) CTSU Data Transmittal Form No No Fillable Printable Form and instruction attachment_1m_8233form.pdf
Individuals or Households 600 100 0

Attach 1W - 8121 CTSU Data Transmittal Form No Health Health Care Services
23 Attach 1W - 8121 CTSU Data Transmittal Form Yes No Fillable Printable Form and instruction attach_1w_8121dtf.zip
Private Sector 0 0 0

Attach 1X- Site Initiated Data Update Form, Protocol 8121 No Health Health Care Services
24 Attach 1X- Site Initiated Data Update Form, Protocol 8121 Yes No Fillable Printable Form and instruction attach_1x_8121duf.zip
Private Sector 0 0 0

Attach 1Y - USMCI 8214/Z6091: CTSU Data Transmittal No Health Health Care Services
25 Attach 1Y - USMCI 8214/Z6091: CTSU Data Transmittal Yes No Fillable Printable Form and instruction attach_1y_8214dtf.zip
Private Sector 0 0 0

Attach 1Z - USMCI 8214/Z6091 Crossover Request/Checklist Transmittal Form No Health Health Care Services
26 Attach 1Z - USMCI 8214/Z6091 Crossover Request/Checklist Transmittal Form Yes No Fillable Printable Form and instruction attach_1z_8214crsov.pdf
Private Sector 0 0 0

Attach 1o - CTSU Patient Enrollment Transmittal Form No Health Health Care Services
15 CTSU Patient Enrollment Transmittal Form No No Fillable Printable Form and instruction attachment_1o_ptentf.pdf
Individuals or Households 2400 400 0

Attach 1P - CTSU P2C Enrollment Transmittal Form No Health Health Care Services
16 CTSU P2C Enrollment Transmittal Form No No Fillable Printable Form and instruction attachment_1p_p2centf.pdf
Individuals or Households 180 30 0

Attach 1Q - CTSU Transfer Form No Health Health Care Services
17 CTSU Transfer Form No No Fillable Printable Form and instruction attachment_1q_transfer.pdf
Individuals or Households 240 40 0

Attach 1R - CTSU System Account Request Form No Health Health Care Services
18 CTSU System Account Request Form Yes No Fillable Fileable Form and instruction attachment_1r_csarf.pdf
Individuals or Households 240 80 0

Attach 1S - CTSU Request for Clinical Brochure No Health Health Care Services
19 CTSU Request for Clinical Brochure No No Fillable Printable Form and instruction attachment_1s_clinbroch.pdf
Individuals or Households 900 150 0

Attach 1T - CTSU Supply Request Form No Health Health Care Services
20 CTSU Supply Request Form No No Fillable Printable Form and instruction attachment_1t_supply.pdf
Individuals or Households 900 150 0

Attach 2 - CTSU Web Site Customer Satisfaction Survey No Health Health Care Services
23 OPEN-Website Survey Yes Yes Fillable Fileable Form and instruction attachment_2_websurvey.docx
Individuals or Households 275 69 0

Attach 3 - CTSU Helpdesk Customer Satisfaction Survey No Health Health Care Services
22 Help Desk Survey Customer Satisfaction Survey Yes Yes Fillable Fileable Form and instruction attachment_3_hdsurvey.docx
Individuals or Households 325 81 0

Attach 4 - CTSU Oncology Patient Enrollment Network (OPEN) Survey No Health Health Care Services
23 Oncology Patient Enrollment Network (OPEN) Survey Yes Yes Fillable Fileable Form and instruction attachment_4_OPEN survey.pdf
State, Local, and Tribal Governments 60 15 0

Attach 1N - CTSU Generic Data Transmittal Form No Health Health Care Services
14 CTSU Generic Data Transmittal Form Yes No Fillable Fileable Form and instruction attachment_1n_gendata.pdf
Individuals or Households 6000 1000 0

Attach 1E_CTSU Site Addition Form No Health Health Care Services
5 Site Addition Form Yes No Fillable Fileable Signable Form and instruction attachment_1e_siteadd.pdf
Individuals or Households 300 25 0

Attach 5 - Protocol and Information Office (PIO) External Customer Satisfaction No Health Health Care Services
24 Protocol and Information Office (PIO) External Customer Satisfaction Yes Yes Fillable Fileable Form and instruction attachment_5_PIO survey.docx
Individuals or Households 100 8 0

Attach 6 - Concept Clinical Trial Survey No Health Health Care Services
25 Concept Clinical Trial Survey Yes Yes Fillable Fileable Form and instruction attachment_6_conceptsurvey.docx
Individuals or Households 500 42 0

Attach 7 - Prospective Clinical Trial Survey No Health Health Care Services
26 Prospective Clinical Trial Survey Yes Yes Fillable Fileable Form and instruction attachment_7_prospectivesurvey.docx
Individuals or Households 1000 83 0

Attach 8 - Low Accruing Clinical Trial Survey No Health Health Care Services
27 Low Accrual Clinical Trial Survey Yes Yes Fillable Fileable Form and instruction attachment_8_lowaccruingsurvey.docx
Individuals or Households 1000 83 0

2014-01-03-05:00

0925-0625 201311-0925-004 0925
             
        "NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)"
             
          
        
The National Cancer Institute (NCI) Central Institutional Review Board (CIRB) provides a centralized approach to human subject protection and provides a cost efficient approach avoiding duplication of effort at each institution. The CIRB provides the services of a fully constituted IRB and provides a comprehensive and efficient mechanism to meet regulatory requirements pertaining to human subject protections including: initial reviews, continuing reviews, review of amendments, and adverse events. The Initiative consists of three central IRBs: Adult CIRB - late phase emphasis, Adult CIRB - early phase emphasis, and Pediatric CIRB. CIRB membership includes oncology physicians, surgeons, nurses, patient advocates, ethicists, statisticians, pharmacists, attorneys and other health professionals. The benefits of the CIRB Initiative reaches research participants, investigators and research staff, Institutional Review Boards (IRB), and Institutions. Benefits include: study participants having dedicated review of NCI-sponsored trials for participant protections, access to more trials more quickly and access to trials for rare diseases, accrual to trials begin more rapidly, ease of opening trials, elimination of need to submit study materials to local IRBs, and elimination of the need for a full board review. The benefits to the National Clinical Trials Network and Experimental Therapy-Clinical Trials Network include a cost efficient approach that avoids duplication of efforts at each institution. A variety of information collection tools to support NCI's CIRB activities which include: worksheets, forms and a survey that is provided to all customers contacting the CIRB helpdesk. 2016-12-31-05:00 Active Mikia Currie 3014350941 No No No 6085 2199 0

CIRB Helpdesk Survey (Attach 1B) No Health Health Care Services
1 Survey (Attachment 1B) Yes Yes Fillable Fileable Form and instruction 1B_Survey_2013.pdf
Individuals or Households 1500 250 0

NCI CIRB Institution Enrollment Worksheet (Attach 2C) No Health Health Care Services
2c NCI CIRB Signatory Yes Yes Fillable Fileable Form and instruction 2C_NCI_CIRB_Enrollment_Form_06212013.doc
Individuals or Households 40 160 0

IRB Staff at Signatory Institution's IRB (Attach 2D) No Health Health Care Services
2d IRB Staff at Signatory Institution's IRB Yes Yes Fillable Fileable Form and instruction 2D_IRB Staff_SI_IRB.docx
Individuals or Households 25 4 0

Investigator at Signatory Institution (Attach 2E) No Health Health Care Services
2e Investigator at Signatory Institution Yes Yes Fillable Fileable Form and instruction 2E_Personnel_SignatoryInstitution.doc
Individuals or Households 65 11 0

Research Staff at Signatory Institution (Attach 2F) No Health Health Care Services
2f Research Staff at Signatory Institution Yes Yes Fillable Fileable Form and instruction 2F_Research Staff_SI.docx
Individuals or Households 65 11 0

Investigator at Affiliate Institution (Attach 2G) No Health Health Care Services
2g Investigator at Affiliate Institution with an IRB Yes Yes Fillable Fileable Form and instruction 2G_Investigator_AI withIRB.docx
Individuals or Households 25 4 0

Research Staff at Affiliate Institution (Attach 2H) No Health Health Care Services
2h Research Staff at Affiliate Institution with an IRB Yes Yes Fillable Fileable Form and instruction 2H_Research Staff_AI withIRB.docx
Individuals or Households 25 4 0

IRB at Signatory Institution (Attach 2L) No Health Health Care Services
2l IRB at Signatory Institution Yes Yes Fillable Fileable Form and instruction 2L_IRB at SI.docx
Individuals or Households 25 4 0

Component Institution at Signatory Institution (Attach 2M) No Health Health Care Services
2m Component Institution at Signatory Institution Yes Yes Fillable Fileable Form and instruction 2M_Component atSI.docx
Individuals or Households 65 11 0

IRB at Affiliate Institution (Attach 2N) No Health Health Care Services
2n IRB at Affiliate Institution Yes Yes Fillable Fileable Form and instruction 2N_IRB at AI.docx
Individuals or Households 25 4 0

Institution Affiliate Institution without an IRB (Attach 2O) No Health Health Care Services
2o Affiliate Institution without an IRB Yes Yes Fillable Fileable Form and instruction 2O_AI without IRB.docx
Individuals or Households 25 4 0

Request for 30-Day Access Form (Attach 2A) No Health Health Care Services
2a Request for 30 Day Website Access Form Yes Yes Fillable Fileable Form and instruction 2A_30-day Website Access Form_2011.doc
Individuals or Households 25 4 0

Facilitated Review Acceptance Form (FRAF) (Attach 2P) No Health Health Care Services
2p Facilitated Review Acceptance Form Yes Yes Fillable Fileable Form and instruction 2P_FR Acceptance Form.doc
Individuals or Households 300 50 0

Study Review Responsibility Transfer Form (Attach 2Q) No Health Health Care Services
2q Study Review Responsibility Transfer Form Yes Yes Fillable Fileable Form and instruction 2Q_SRRT Form_072310_screenshot_REV.doc
Individuals or Households 80 13 0

CIRB New Board Member Biographical Sketch Form (Attach 3B) No Health Health Care Services
3b CIRB Board Member Biographical Sketch Form Yes Yes Fillable Fileable Form and instruction 3B - CIRB_New BMO_BioSketch.doc
Individuals or Households 25 6 0

CIRB New Board Member Contact Information Form (Attach 3C) No Health Health Care Services
3c CIRB Board Member Contact Information Form No No Fillable Fileable Form and instruction 3C - CIRB_New BMO_ContactInfo.doc
Individuals or Households 25 4 0

CIRB New Board Member W-9 (Attach 3D) No Health Health Care Services
3d CIRB Board Member W-9 Yes No Printable Only Form and instruction 3D - CIRB_New BMO_W-9.doc
Individuals or Households 25 6 0

Direct Deposit Form (Attach 4) No Health Health Care Services
4 CIRB Direct Deposit Form No No Printable Only Form and instruction 4 - CIRB Direct Deposit Form_CIRB_OMB_PRV_TITLE.doc
Individuals or Households 25 6 0

CIRB New Board Member Non-Disclosure Agreement (NDA) (Attach 3E) No Health Health Care Services
3e CIRB Board Member Non-Disclosure Agreement (NDA) Yes Yes Fillable Fileable Form and instruction 3E - CIRB_New BMO_NDA.doc
Individuals or Households 25 4 0

NCI Adult CIRB Application and Adult-Peds Treatment Studies (Attach 5A) No Health Health Care Services
5a NCI Adult/Pediatric CIRB Application for Treatment Studies Yes Yes Fillable Fileable Form and instruction 5A_Application_Treatment_FINAL 012511.doc
Individuals or Households 25 50 0

NCI Pediatric CIRB Application (Attach 5B) No Health Health Care Services
21a NCI Pediatric CIRB Application Yes Yes Fillable Fileable Form and instruction Attach 5B - CIRB Peds_NEW.pdf 21a NCI Pediatric CIRB Application Yes Yes Fillable Fileable Form and instruction Attach 5B - CIRB Peds_Change with Highlights.pdf 21 NCI Pediatric CIRB Application Yes Yes Fillable Fileable Form and instruction Attachment 5B - CIRB_Peds_Appl_ 110110.pdf
Private Sector 0 0 0

Adult/Pediatric CIRB Application - Ancillary Studies (Attach 5B ) No Health Health Care Services
22 Adult/Pediatric CIRB Application - Ancillary Studies Yes Yes Fillable Fileable Form and instruction 5B_Application_Ancillary Protocol Review_021911.doc
Individuals or Households 10 20 0

Summary of CIRB Application Revisions (Attach 5D) No Health Health Care Services
5d Summary of CIRB Application Revisions Yes Yes Fillable Fileable Form and instruction 5D_Application_Revisions_Summary.doc
Individuals or Households 20 10 0

Adult/Pediatric CIRB Application for Continuing Review (Attach 5C) No Health Health Care Services
5c NCI Adult/Pediatric CIRB Application for Continuing Review Yes Yes Fillable Fileable Form and instruction 5C_Application_CR_FINAL_v021911.rtf
Individuals or Households 80 80 0

Adult Initial Review of Cooperative Group Protocol (Attach 6A) No Health Health Care Services
6a Adult Initial Review of Cooperative Group Protocol Yes Yes Fillable Fileable Form and instruction 6A_IR_FB_ADULT_Reviewer Worksheet.doc
Individuals or Households 15 60 0

Pediatric Initial Review of Cooperative Group Protocol (Attach 6B) No Health Health Care Services
6b Pediatric Initial Review of Cooperative Group Protocol Yes Yes Fillable Fileable Form and instruction 6B_IR_FB_PEDS_Reviewer Worksheet.doc
Individuals or Households 15 60 0

Adult CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6G) No Health Health Care Services
6g Adult Cooperative Group Response to CIRB Review Yes Yes Fillable Fileable Form and instruction 6G_SCResponse_FB_ADULT_Reviewer Form.doc
Individuals or Households 15 15 0

Pediatric CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attach 6H) No Health Health Care Services
6h Pediatric Cooperative Group Response to CIRB Review Yes Yes Fillable Fileable Form and instruction 6H_SCResponse_FB_PEDS_Reviewer Form.doc
Individuals or Households 10 10 0

Adult Amendment of Cooperative Group Protocol (Attach 6E) No Health Health Care Services
6e Adult Amendment of Cooperative Group Protocol Yes Yes Fillable Fileable Form and instruction 6E_AR_FB_ADULT_Reviewer Worksheet_061913.doc
Individuals or Households 10 20 0

Pediatric Amendment of Cooperative Group Protocol (Attach 6F) No Health Health Care Services
6f Pediatric Amendment of Cooperative Group Protocol Yes Yes Fillable Fileable Form and instruction 6F_AR_FB_PEDS_Reviewer Worksheet.doc
Individuals or Households 10 20 0

Adult Continuing Review of Cooperative Group Protocol (Attach 6C) No Health Health Care Services
6c Adult Continuing Review of Cooperative Group Protocol Yes Yes Fillable Fileable Form and instruction 6C_CR_FB_ADULT_Reviewer Worksheet.doc
Individuals or Households 130 130 0

Pediatric Continuing Review of Cooperative Group Protocol (Attach 6D) No Health Health Care Services
6d Pediatric Continuing Review of Cooperative Group Protocol Yes Yes Fillable Fileable Form and instruction 6D_CR_FB_PEDS_Reviewer Worksheet.doc
Individuals or Households 70 70 0

Pediatric Pharmacist's Review of a Cooperative Group Study (Attach 6J) No Health Health Care Services
2 Pediatric Pharmacist's Review of a Cooperative Group Study Yes Yes Fillable Fileable Form and instruction 6J_Pharma_FB_PEDS_Reviewer Form.doc
Individuals or Households 20 40 0

CIRB Statistical Reviewer Form (Attach 6K) No Health Health Care Services
6k CIRB Statistical Reviewer Form Yes Yes Fillable Fileable Form and instruction 6K_Stat_FB_Reviewer Form.doc
Individuals or Households 30 15 0

CIRB SAE Reviewer Worksheet (Attach 6K) No Health Health Care Services
35 CIRB SAE Reviewer Worksheet Yes Yes Fillable Fileable Form and instruction Attachment 6K - CIRB SAE SAE Worksheet to Reviewer_Template_110110.pdf
Private Sector 0 0 0

Research Staff at Affiliated Institution without an IRB (Attach 2J) No Health Health Care Services
4 Researcg Staff at Affiliate Institution without an IRB Yes Yes Fillable Fileable Form and instruction 2J_Research Staff_AI without IRB.docx
Individuals or Households 25 4 0

Institutional Contact for Signatory Institution (Attach 2K) No Health Health Care Services
5 Institutional Contact for Signatory Institution Yes Yes Fillable Fileable Form and instruction 2K_ InstitutionalContact for SI.docx
Individuals or Households 65 11 0

Annual Institutional Worksheet About Local Context (Attach 2R) No Health Health Care Services
2r Annual Institution Worksheet About Local Context Yes Yes Fillable Fileable Form and instruction 2R_Annual SI Worksheet About LC_screenshot_REV.docx
Individuals or Households 120 40 0

Investigator at Affiliate Institution without IRB (Attach 2I) No Health Health Care Services
3 Investigator at Affiliate Institution without IRB No Yes Fillable Fileable Form and instruction 2I_Investigator_AI without IRB.docx
Individuals or Households 25 4 0

Annual Principal Investigator Worksheet About Local Context (Attach 2S) No Health Health Care Services
7 Annual Principal Investigator Worksheet ABout Local Context Yes Yes Fillable Fileable Form and instruction 2S_Annual PI Worksheet About LC_screenshot_REV.docx
Individuals or Households 120 40 0

Study-Specific Worksheet About Local Context (Atttach 2T) No Health Health Care Services
8 Study-Specific Work sheet About Local Context Yes Yes Fillable Fileable Form and instruction 2T_Study-Specific Worksheet About LC 122012_screenshot doc_REV.docx
Individuals or Households 220 73 0

Study Closure or Transfer of Study Review Responsibility Form (Attach 2U) No Health Health Care Services
9 Study Closure or Transfer of Study Review Responsibility Form Yes Yes Fillable Fileable Form and instruction 2U_Study Closure or Transfer of Study Resp_011513_screenshot_REV.docx
Individuals or Households 120 20 0

Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form (Attach 2V) No Health Health Care Services
10 Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form Yes Yes Fillable Fileable Form and instruction 2V_Potential UP_SCN_Form_011513_screenshot_REV.docx
Individuals or Households 120 30 0

Add or Remove Signatory and /or Component Institution Personnel (Attach 2W) No Health Health Care Services
11 Add or Remove Signatory and /or Component Institution Personnel Yes Yes Fillable Fileable Form and instruction 2W_Add or Remove Sig or CI Personnel.doc
Individuals or Households 120 20 0

Add or Remove Affiliate Institution Personnel (Attach 2X) No Health Health Care Services
2x Add or Remove Affiliate Institution Personnel Yes Yes Fillable Fileable Form and instruction 2X_Add or Remove _AI Personnel.doc
Individuals or Households 120 20 0

Add or Remove Component Institution (Attach 2Y) No Health Health Care Services
13 Add or Remove Component Institution Yes Yes Fillable Fileable Form and instruction 2Y_Add or Remve_CI.doc
Individuals or Households 120 20 0

Add or Remove Affiliate Institution (Attach 2Z) No Health Health Care Services
14 Add or Remove Affiliate Institution Yes Yes Fillable Fileable Form and instruction 2Z_Add or Remove AI.doc
Individuals or Households 120 20 0

One Time Study Roll Over Worksheet (Attach 2ZA) No Health Health Care Services
15 One Time Study Roll Over Worksheet Yes Yes Fillable Fileable Form and instruction 2ZA_One Time Study Rollover Worksheet About Local Context 062211.docx
Individuals or Households 120 20 0

Change of Signatory Institution PI Form (Attach 2ZB) No Health Health Care Services
16 Change of Signatory Institution PI Form Yes Yes Fillable Fileable Form and instruction 2ZB_Change of SI_PI_Form_082412.docx
Individuals or Households 120 20 0

Locally-Developed Material Submission Form (Attach 5E) No Health Health Care Services
17 Locally-Developed Material Submission Form Yes Yes Fillable Fileable Form and instruction 5E_Locally-Developed_Material_Submission_Form 022812.doc
Individuals or Households 15 4 0

Application Request to Review Translated Documents (Attach 5F) No Health Health Care Services
18 Application Request to Review Translated Documents Yes Yes Fillable Fileable Form and instruction 5F_Application for Translation Review_per071211 Clean.doc
Individuals or Households 15 4 0

Determination of Unanticipated Problem (UP) and/or Serious or Continuing Noncompliance (SCN) (Attach 6L) No Health Health Care Services
20 Determination of Unanticipated Problem (UP) and/or Serious or Continuing Noncompliance (SCN) Yes Yes Fillable Fileable Form and instruction 6L_UP_FB_Reviewer Form.doc
Individuals or Households 40 7 0

Adult Expedited Amendment Review (Attach 6M) No Health Health Care Services
21 Adult Expedited Amendment Review Yes Yes Fillable Fileable Form and instruction 6M_AR_ER_ADULT_Reviewer Worksheet_v5_041612.doc
Individuals or Households 350 175 0

Ped Expedited Amendment Review (Attach 6N) No Health Health Care Services
21 Ped Expedited Amendment Review Yes Yes Fillable Fileable Form and instruction 6N_AR_ER_PEDS_Reviewer Worksheet_v5_041612.doc
Individuals or Households 150 75 0

Adult Expedited Continuing Review (Attach 6O) No Health Health Care Services
22 Adult Expedited Continuing Review Yes Yes Fillable Fileable Form and instruction 6O_CR_ER_ADULT_Reviewer Checklist_v5_041612.doc
Individuals or Households 120 60 0

Ped Expedited Continuing Review (Attach 6P) No Health Health Care Services
23 Ped Expedited Continuing Review Yes Yes Fillable Fileable Form and instruction 6P_CR_ER_PEDS_Reviewer Worksheet_v5_041612.docx
Individuals or Households 70 35 0

Adult Expedited Study Closure (Attach 6Q) No Health Health Care Services
24 Adult Expedited Study Closure (Attach 6Q) Yes Yes Fillable Fileable Form and instruction 6Q_Adult_ER_ClosureWksht_v1.3_041513_Adult.doc
Individuals or Households 20 7 0

Ped Expedited Study Closure (Attach 6R) No Health Health Care Services
25 Ped Expedited Study Closure (Attach 6R) Yes Yes Fillable Fileable Form and instruction 6R_Ped_ER_ClosureWksht_v1.3_041513_Pediatric.doc
Individuals or Households 20 7 0

Adult Expedited Study Chair Response to Required Mod (Attach 6S) No Health Health Care Services
26 Adult Expedited Study Chair Response to Required Mod (Attach 6S) Yes Yes Fillable Fileable Form and instruction 6S_Adult_ER_SCRWksht_v1.3_041513_Adult.doc
Individuals or Households 350 88 0

Ped Expedited Study Chair Response to Required Mod (Attach 6T) No Health Health Care Services
27 Ped Expedited Study Chair Response to Required Mod (Attach 6T) Yes Yes Fillable Fileable Form and instruction 6T_Ped_ER_SCRWksht_v1.3_041513_Pediatric.doc
Individuals or Households 150 38 0

Reviewer Worksheet of Translated Documents (Attach 6U) No Health Health Care Services
28 Reviewer Worksheet of Translated Documents Yes Yes Fillable Fileable Form and instruction 6U_Rev Worksheet for Translation Review per071211.doc
Individuals or Households 15 4 0

Reviewer Advertisement Checklist (Attach 6V) No Health Health Care Services
29 Reviewer Advertisement Checklist (Attach 6V) Yes Yes Fillable Fileable Form and instruction 6V_RecMat_FB_Reviewer Worksheet_112612.doc
Individuals or Households 10 3 0

Adult Pharmacist's Review of a Cooperative Group Study (Attach 6I) No Health Health Care Services
29 Adult Pharmacist's Review of a Cooperative Group Study Yes Yes Fillable Fileable Form and instruction 6I_Pharma_FB_ADULT_Reviewer Form.doc
Individuals or Households 10 20 0

Authorization Agreement and Division of Responsibilities b/w NCI CIRB and Signatory Institution (Attach 2B) No Health Health Care Services
2b Authorization Agreement and Division of Responsibilities between CIRB and Signatory Institution Yes Yes Fillable Fileable Form and instruction 2B_AuthAgreement_DofR.doc
Individuals or Households 340 170 0

2013-12-26-05:00

0925-0626 201012-0925-004 0925
             
        "Gulf Long-Term Follow-Up Study for Oil Spill Clean-Up Workers and Volunteers (NIEHS)"
             
          
        
The purpose of the GuLF Study is to investigate potential short- and long-term health effects associated with oil spill clean-up activities and exposures surrounding the Deepwater Horizon disaster; and secondarily to create a resource for additional collaborative research on focused hypotheses or subgroups. Over 55,000 persons participating in oil-spill clean-up activities have been exposed to a range of known and suspected toxins in crude oil, burning oil, and dispersants, to excessive heat; and possibly stress due to widespread economic and lifestyle disruption . Exposures range from negligible to potentially significant, however, the potential long-term human health consequences are largely unknown due to a dearth of research in this area. Participants will be recruited from across job/exposure groups of primarily English, Spanish, or Vietnamese speaking adults (accommodations for other languages developed as appropriate) who performed oil-spill clean-up-related work ("exposed") and similar persons who engaged in no clean-up-related work ("unexposed" controls), and followed in either an Active Follow-up Cohort (N~27,000) or a Passive Follow-up Cohort (N~28,000). 2014-02-28-05:00 Active Mikia Currie 3014350941 No No No 55000 52000 0

Gulf Study Participants No General Science and Innovation Scientific and Technological Research and Innovation
1 Enrollment Yes Yes Paper Only Form and instruction GuLFOMBattachment7REVISEDAppendix_I_-_Telephone_Scripts_and_Questionnaire20110120.pdf 2 Baseline Yes Yes Paper Only Form and instruction GuLFOMBattachment8REVISEDAppendix_J_-_Home_Visit_Scripts_and_Questionnaire20110120.pdf
Individuals or Households 55000 52000 0

2011-01-21-05:00

0925-0627 201103-0925-002 0925
             
        "GENERIC CLEARANCE FOR SURVEYS OF THE OFFICE OF EXTRAMURAL RESEARCH (OD)"
             
          
        
The mission of the National Institutes of Health (NIH) is to improve human health through biomedical and behavioral research. The NIH implements this mission by conducting intramural research in its own laboratories; supporting extramural research by scientists at universities, medical schools, hospitals, and research institutes; training basic and clinical research investigators; and fostering and supporting biomedical communication as well as public health information dissemination. OER/OD/NIH exercises overall oversight for the policies and procedures governing the award of financial support representing more than 80% of the total NIH budget ($30.5 billion in FY2010) to the extramural scientific community and academic research institutions through both assistance and acquisition mechanisms by the Institutes and Centers (ICs) which comprise the NIH. 2014-02-28-05:00 Active Mikia Currie 3014350941 No No No 294600 74010 0

OER SBIR Program Office Post-Conference Survey of the 2011 SBIR/STTR Conference Attendees No Health Health Care Services
1 Survey Yes Yes Fillable Fileable Form and instruction SBIR Conference Feedback _OMB Cleared No 0925-0627_7-26-11_Final.pdf
Individuals or Households 450 75 0

NIH External Constituency Surveys No Health Health Care Services
3 Advisory Council Survey Yes Yes Fillable Fileable Form and instruction Attach 3 - Advisory Council Web-Based Survey Instrument.pdf 2 Reviewer Survey Yes Yes Fillable Fileable Form and instruction Attach 2 - Reviewer Web-based Survey Instrument.pdf 1 Applicant Survey Yes Yes Fillable Fileable Form and instruction Attach 1 - Applicant Web-based Survey Instrument.pdf
Individuals or Households 4710 2293 0

Survey of Loan Repayment Program Participants No Health Health Care Services
1 DLR Survey Screenshots Yes Yes Fillable Fileable Form and instruction Attachment 3 - DLR Survey Screenshots_.docx
Individuals or Households 1800 600 0

NIH CAP 2013 Feedback Form No Health Health Care Services
1 CAP Feedback Form (Screenshot) Yes Yes Fillable Printable Form and instruction CAP_Feedback_Screenshot_9.9.13_Revised.docx
Private Sector 68 17 0

NIH Postdoctoral Benefits Survey No Health Consumer Health and Safety
1 NIH Postdoctoral Benefits Survey Yes Yes Fillable Fileable Form and instruction NIH Postdoctoral Benefits Survey_Questionnaire Screenshots 12.2013.doc
Private Sector 250 375 0

2011-03-04-05:00

0925-0628 201101-0925-001 0925
             
        "National Epidemiologic Survey on Alcohol and Related Conditions-III (NIAAA)"
             
          
        
The National Epidemiologic Survey on Alcohol and Related Conditions - III (NESARC-III) is a nationally representative survey of 46,500 adult Americans that will collect data on alcohol use disorders and their associated disabilities in addition to collecting saliva samples for the purpose of understanding the prevalence, risk factors, health disparities, economic costs and gene-environment interactions related to alcohol use disorders and their associated disabilities. There is a small reliability (n=1,000) and a small validity (n=700) methodological component (interviewing NESARC-III survey proper respondents twice) and a proposed pilot study (n=100). 2014-04-30-04:00 Active Mikia Currie 3014350941 No No No 48300 47800 0

Adults-NESARC-III No Health Health Care Services Individuals or Households 44900 44900 0

Adults-including respondents participating in re-interview with AUDADIS-V or PRISM No Health Health Care Services Individuals or Households 2000 1500 0

Adults-Reinterview, Validity Study No Health Health Care Services Individuals or Households 1400 1400 0

2011-04-08-04:00

0925-0629 201101-0925-005 0925
             
        "National Evaluation of the Clinical and Translational Science Awards (CTSA) Initiative (NCRR)"
             
          
        
The CTSA Initiative is administered by the Division of Clinical Research Resources (DCRR) within NCRR. The Initiative was designed to spur the transformation of the biomedical research enterprise in the United States so that new treatments can be developed more efficiently and delivered more quickly to patients. The Initiative enables institutions to create an integrated academic home for clinical and translational science that has the resources to train and advance multi- and interdisciplinary investigators and research teams. CTSAs engage basic, translational, and clinical investigators, community clinicians, clinical practices, networks, professional societies, and industry to develop new professional interactions, programs, and research projects. The CTSA Initiative is designed to fundamentally change the organization and operating paradigm of research in major academic medical centers by providing infrastructure resources to support clinical and translational science activities and training for the next generation of scientists. 2014-04-30-04:00 Active Mikia Currie 3014350941 No No No 903 452 0

Users No Health Health Care Services
1 Users Survey Yes Yes Paper Only Form and instruction User Survey CTSA OMB attach 1.doc
Individuals or Households 125 63 0

Nonusers No Health Health Care Services
2 Nonusers Yes Yes Paper Only Form and instruction NonUser Survey CTSA OMB attach 1.doc
Individuals or Households 40 20 0

Trainees/Scholars No Health Health Care Services
3 Trainees/Scholars Survey Yes Yes Paper Only Form and instruction Trainees Scholar Survey CTSA OMB attach 1.doc
Individuals or Households 400 200 0

Mentors No Health Health Care Services
4 Mentors Survey Yes Yes Paper Only Form and instruction Mentor Survey CTSA OMB attach 1.doc
Individuals or Households 338 169 0

2011-04-08-04:00

0925-0630 201211-0925-006 0925
             
        "Transfusion-transmitted retrovirus and hepatitis virus rates and risk factors: Improving the safety of the US blood supply through hemovigilance  (NHLBI)"
             
          
        
Information on current risk factors in blood donors as assessed using analytical study designs is largely unavailable in the US. This project represents a collaborative pilot research study that will include a comprehensive interview study of viral infection positive blood donors at the American Red Cross (ARC), Blood Systems Inc. (BSI) and New York Blood Center (NYBC) in order to identify the current predominant risk factors for virus positive donations and will also establish a donor biovigilance capacity that currently does not exist in the US. At this time it is not easy to integrate risk factor data and disease marker surveillance information within or across different blood collection organizations because common interview procedures and laboratory confirmation procedures are not being used and so we cannot easily tabulate and analyze behavioral risks or viral infections in US blood donors. This creates the potential for gaps in our understanding of absolute incidence and prevalence as well as risks that could lead to transfusion-transmitted disease. 2014-04-30-04:00 Active Mikia Currie 3014350941 No No No 4150 2407 0

Blood Donors No Health Public Health Monitoring
1 Survey No No Paper Only Form and instruction 2674-1 Applicant Informaiton with NIH Commons OMB[1].pdf
Individuals or Households 4150 2407 0

2012-11-09-05:00

0925-0631 201102-0925-003 0925
             
        "Recruitment and Screening for the Insight into Determination of Exceptional Aging and Longevity (IDEAL) Study (NIA)"
             
          
        
The purpose of the project for which we are seeking OMB approval is to conduct recruitment and screening for the Insight into the Determination of Exceptional Aging and Longevity (IDEAL) Study. The IDEAL Study cohort will be compared to current Baltimore Longitudinal Study of Aging (BLSA) participants who were no longer healthy or fully functional when they reached the age of 80. A secondary objective of the IDEAL Study is to identify physiological, environmental and behavioral characteristics that are risk factors for loss of a person's healthy aging status over time. 2014-04-30-04:00 Active Mikia Currie 3014350941 No No No 1500 701 0

Individuals No Health Health Care Services
1 Telephone Interview Yes Yes Paper Only Form and instruction Attachment 5 Telephone Interview v5 (2578 - Activated Traditional).pdf 3 Phone Questionnaire Yes Yes Paper Only Form and instruction PhoneQuestionnaire v6 (35261 - Traditional).pdf 2 Physical Exam Yes Yes Paper Only Form and instruction Attachment 8-PhysicalExam v3 (59451- Activated Traditional).pdf
Individuals or Households 1500 701 0

2011-04-08-04:00

0925-0632 201102-0925-010 0925
             
        "Online Skills Training for PCPs on Substance Abuse (NIDA)"
             
          
        
The purpose of the data collection is to evaluate an educational program developed with funding from NIDA through a Small Business Innovation Research (SBIR) contract. This project is developing online training and education materials for primary care physicians (PCPs). "Primary care physician" is defined as a physician who specializes in family medicine, internal medicine, pediatrics in primary care, obstetrics or gynecology in primary care, and emergency medicine for acute primary care problems. The educational goal of these materials is to teach PCPs about screening, brief intervention, and treatment to referral (SBIRT) for substance abuse. The project will create a multimedia, interactive program with didactic online learning and skills training via video and Internet based chat experiences mimicking the "Objective Structured Clinical Examination" (OSCE) interactions familiar to PCPs from their professional training. 2014-04-30-04:00 Active Mikia Currie 3014350941 No No No 240 180 0

Physicians No Education Higher Education
2 Assessment Yes Yes Fillable Fileable Form and instruction N44DA-9-2214-Attachment5AssessmentForms_March2011.doc 2 Assessment Yes Yes Paper Only Form and instruction 1 Screener Yes Yes Paper Only Form and instruction 1 Screener Yes Yes Fillable Fileable Form and instruction N44DA-9-2214Attachment3ScreeningTool_March2011.doc
Individuals or Households 240 180 0

2011-04-08-04:00

0925-0633 201103-0925-003 0925
             
        "Generic Submission of Technology Transfer Center (TTC) External Customer Satisfaction Surveys (NCI)"
             
          
        
The current study is designed to assess the needs and attitudes of external customers (i.e., industrial biotechnology, pharmaceutical, and medical device executives) who are current and potential collaborators and licensees for NIH technologies and who have a strategic view of their needs with respect to research collaborations. The needs of for-profit companies and not-for-profit organizations that conduct research and development in biomedical applications (TTC external customers) have never been assessed systematically. Input from these groups is essential for defining workflow process improvements for services provided by the NCI TTC to the research community. The purpose of this study is to: obtain information on the satisfaction of TTC's external customers with TTC customer services; collect information of preferred and expected communications channels of TTC's external customers; and assess the strategic direction of companies engaging in collaborations and alliances with the NIH. The results will be used to strengthen the operations of the NCI TTC, including the Competitive Service Center. Specifically, new data on customer needs will be used to assess progress relative to existing process goals, revise them as necessary, and establish new goals and priorities for meeting customer needs. 2014-02-28-05:00 Active Mikia Currie 3014350941 No No No 4000 1333 0

Sub-study #1_TTC External Customer Satisfaction Survey No General Science and Innovation Scientific and Technological Research and Innovation
1 Sub-study #1 Yes Yes Fillable Fileable Form and instruction Attach 1_TTC_Consent and Survey_12-13-10 JDH.doc
Private Sector 2052 684 0

2011-04-25-04:00

0925-0634 201103-0925-005 0925
             
        "Testing successful health communications surrounding aging-related issues from the National Institute on Aging (NIA)"
             
          
        
NIA Office of Communications and Public Liaison (OCPL) can better meet NIA's communications mission by developing evidence-based materials. This will require OCPL to conduct primary research with older adults, caregivers, health professionals and other people who work with older people to determine what health and aging topics are of interest and not represented by NIA's current materials. OCPL must also work directly with these audiences to determine the most effective presentation of NIA's health information through the development of new materials and through outreach to raise awareness of NIA's resources. NIA plans to conduct formative research with its key audiences--older people, caregivers, health professionals, and others who work with older people. This type of research involves (1) assessing audiences' trusted/preferred sources for information, knowledge, attitudes, behaviors, and other characteristics for the planning/development of health messages and communications strategies and (2) pretesting health messages and outreach strategies while they are in developmental form to assess audience response, including their likes and dislikes. 2014-05-31-04:00 Active Mikia Currie 3014350941 No No No 1890 702 0

Focus Groups with Senior Center Staff/Administrators No Health Health Care Services
2 questionaire Yes Yes Fillable Fileable Form NIA Focus Group Question Guide-2.docx 1 Pre questionaire Yes Yes Fillable Fileable Form NIA pre-focus group questionnaire-2.docx
Individuals or Households 54 45 0

Focus Groups with Family Caregivers No Health Health Care Services
1 Pre-Focus Group Form No No Printable Only Form and instruction 0925-0634 NIA pre-focus group questionnaire--family caregivers rev 9.27.2012.doc 1 Focus Group Questionnaires (Guide) No No Printable Only Form and instruction 0925-0634 NIA Focus Group Question Guide--family caregiver rev 9.27.2012.doc
Individuals or Households 60 70 0

2011-05-02-04:00

0925-0636 201105-0925-002 0925
             
        "cancer Biomedical Informatics Grid (caBIG)(R) Support Service Provider (SSP) Program (NCI)"
             
          
        
The collection of information from Support Service Provider (SSP) applicants, is critical to both ensuring that the goals and objectives of the cancer Biomedical Informatics Grid, or caBIG(R), -- an open source, open access information network that connects the cancer research community and enables the sharing of tools and data through a common, standards-based electronic infrastructure -- will be maintained and furthered by the organizations designated as SSPs and facilitating NCI's ability to exercise appropriate stewardship of the caBIG trademarks. 2014-02-28-05:00 Active Mikia Currie 3014350941 No No No 15 360 0

caBIG Support Service Provider Program Call for Applications No Health Health Care Services
1 Call for Applications Yes Yes Fillable Fileable Form and instruction Attach 1_caBIG_SSP_Announcement.pdf
Private Sector 15 360 0

2011-07-24-04:00

0925-0638 201105-0925-006 0925
             
        "NIH Toolbox for Assessment of Neurological and Behavioral Function (NIA)"
             
          
        
Although there are many studies that collect information on aspects of neurological function and behavioral health (e.g., cognition, sensation, motor functioning, emotion), there is little uniformity among the measures used to assess these constructs. When individual studies employ unique assessment batteries, comparisons between studies and combining data from multiple studies are quite challenging. Thus, investigators have expressed the need for brief, standard assessment tools to be used across diverse study designs and populations. For example, in 2005, a report (Hendrie et al., Alzheimer's & Dementia, vol. 2, 12-32, 2006) was submitted to the staff of the trans-NIH Cognitive and Emotional Health Project (CEHP) that suggested, among other ideas, the need for "standard questionnaires to measure cognitive and emotional health". In response to these issues, the National Institutes of Health (NIH) Toolbox initiative seeks to assemble brief, comprehensive assessment tools to measure cognitive, emotional, sensory and motor function that will be useful to clinicians and researchers in a variety of settings, with a particular emphasis on measuring outcomes in large longitudinal or epidemiologic studies and prevention or intervention trials across the lifespan. Such comprehensive measures are rarely included in studies of this type, due in part to the lack of brief, well-validated instruments. 2014-07-31-04:00 Active Saleda Perryman No No No 19350 37800 0

Adult Study Participants (baseline only + 1 retest) No Health Health Care Services
35 Locomotion 4-meter Walk Test Yes Yes Fillable Fileable Form and instruction Attach 35 Locomotion 4 Meter Walk Test.pdf 33 Dexterity 9-hole Pegboard Yes Yes Fillable Fileable Form and instruction Attach 33 9 Hole Pegboard.pdf 32 Supplemental Emotional Health Questionaire Yes Yes Fillable Fileable Form and instruction Attach 32 Supplemental Emotional Health Questionnaires.xls 31 Emotional Health Questionaire Yes Yes Fillable Fileable Form and instruction Attach 31 Emotional Health Questionnaires for Toolbox.xlsx Yes Yes Fillable Fileable Instruction Attach 30 Instructions for Emotional Health Questionnaire.pdf 29 Word Accentuation (Spanish only) Yes Yes Fillable Fileable Form and instruction Attach 29 Spanish Word Accentuation Test.pdf 28 Vocabulary Comprehension Yes Yes Fillable Fileable Form and instruction Attach 28 Vocabulary Comprehension.pdf 27 Handedness Assessment Yes Yes Fillable Fileable Form and instruction Attach 27 Determining Handedness.pdf 26 Reading Recognition Yes Yes Fillable Fileable Form and instruction Attach 26 Reading Recognition.pdf 24 Pattern Comparison Yes Yes Fillable Fileable Form and instruction Attach 24 Pattern Comparison.pdf 23 Oral Symbol Digit Modalities Yes Yes Paper Only Form and instruction Attach 23 Oral Symbol Digit Modalities Test.pdf 22 List Sorting Yes Yes Fillable Fileable Form and instruction Attach 22 List Sorting.pdf 20 Imitation Based Assessment of Memory Yes Yes Fillable Fileable Form and instruction Attach 20 Flanker.pdf 19 Bateria III Picture Vocabulary (Spanish only) Yes Yes Fillable Fileable Form and instruction Attach 19 Bateria III Picture Vocabulary.pdf 18 Dimensional Card Change Sort Yes Yes Fillable Fileable Form and instruction Attach 18 Dimensional Change Card Sort.pdf 17 Tactile Discrimination Test Yes Yes Fillable Fileable Form and instruction Attach 17 Tactile Discrimination Test.pdf 15 Brief Kinesthesia Test Yes Yes Fillable Fileable Form and instruction Attach 15 Brief Kinesthesia Test.pdf 14 Vision Health Related QOL Survey Yes Yes Fillable Fileable Form and instruction Attach 14 Vision Health-Related Quality of Life Survey.pdf 13 Dynamic Visual Acuity (DVA) No Yes Fillable Fileable Form and instruction Attach 13 Dynamic Visual Acuity (DVA).pdf 12 Toolbox Taste Test Yes Yes Fillable Fileable Form and instruction Attach 12 Toolbox Taste Test.pdf 11 Sucrose Preference Test Yes Yes Fillable Fileable Form and instruction Attach 11 Sucrose Preference Test.pdf 10 PA Ages 18-85 Yes Yes Fillable Fileable Form and instruction Attach 10 Pain Assessment Ages 18-85.pdf 4 Ordor Identification Yes Yes Fillable Fileable Form and instruction Attach 4 Odor Identification Ages 10-85.pdf 3 Words in Noise Yes Yes Fillable Fileable Form and instruction Attach 3 Words-In-Noise Test (WIN).pdf 59 Education Proxy Report for Children Yes Yes Fillable Fileable Form and instruction Attach 59 Education Proxy Report for Children.pdf 58 Education Adult Self-Report Yes Yes Fillable Fileable Form and instruction Attach 58 Education Adult Self-Report.pdf 6 University of Penn Smell Identification Yes Yes Fillable Fileable Form and instruction Attach 6 University of Pennsylvania Smell Identification Test (UPSIT).pdf 1 Automated Audiometry from the NIH Toolbox (AANT) Yes Yes Fillable Fileable Form and instruction Attach 1 Automated Audiometry for the NIH Toolbox (AANT).pdf 2 Hearing Handicap Inventory (HHI) Yes Yes Fillable Fileable Form and instruction Attach 2 Hearing Handicap Inventory.pdf 36 Grip Strength Dynamometry Yes Yes Fillable Fileable Form and instruction Attach 36 Grip Strength Dynamometry.pdf 37 Strength Knee Extension Yes Yes Fillable Fileable Form and instruction Attach 37 Strength Knee Extension.pdf 38 Balance Accelerometer Measure Yes Yes Fillable Fileable Form and instruction Attach 38 Balance Accelerometer Measure (BAM).pdf 39 Initial Adult Questionaire Yes Yes Fillable Fileable Form and instruction Attach 39 Initial Questionnaire - Adult.pdf 41 Additional Somatosensation Questions Yes Yes Fillable Fileable Form and instruction Attach 41 Additional Somatosensation Questions.pdf 42 Additional Audition Olfaction Taste Yes Yes Fillable Fileable Form and instruction Attach 42 Additional Audition Olfaction Taste Questions.pdf 43 Cognition Information Form Yes Yes Fillable Fileable Form and instruction Attach 43 Cognition Information Form.pdf 44 Health Care Access and Utilization Yes Yes Fillable Fileable Form and instruction Attach 44 Health Care Access and Utilization.pdf 45 Instrumental Activities of Daily Living Yes Yes Fillable Fileable Form and instruction Attach 45 Instrumental Activities of Daily Living (IADL) - Adults.pdf 46 Applied Cognition Adult Yes Yes Fillable Fileable Form and instruction Attach 46 Applied Cognition - Adults.xlsx 52 PROMIS 29 Participant Yes Yes Fillable Fileable Form and instruction Attach 52 PROMIS 29 - Participant.pdf 57 EtOH (Alcohol) Questionaire No No Fillable Fileable Form and instruction Attach 57 EtOH Questionnaire.pdf 34 Endurance 2-Minute Walk Test Yes Yes Fillable Fileable Form and instruction Attach 34 Endurance 2 Minute Walk Test (2MWT).pdf 56 Falls Efficscy Scale-International Yes Yes Fillable Fileable Form and instruction Attach 56 Falls Efficacy Scale-International (Short FES-I).pdf 55 Text Anxiety Scale Yes Yes Fillable Fileable Form and instruction Attach 55 Test Anxiety Scale (TAS).pdf
Individuals or Households 5850 17550 0

Children (baseline only + retest) No Health Health Care Services
4 Ordor Identification Yes Yes Fillable Fileable Form and instruction Attach 4 Odor Identification Ages 10-85.pdf 3 Words in Noise Yes Yes Fillable Fileable Form and instruction Attach 3 Words-In-Noise Test (WIN).pdf 6 University of Penn Smell Identification Yes Yes Fillable Fileable Form and instruction Attach 6 University of Pennsylvania Smell Identification Test (UPSIT).pdf 1 Automated Audiometry from the NIH Toolbox (AANT) Yes Yes Fillable Fileable Form and instruction Attach 1 Automated Audiometry for the NIH Toolbox (AANT).pdf 23 Oral Symbol Digit Modalities Yes Yes Paper Only Form and instruction Attach 23 Oral Symbol Digit Modalities Test.pdf 22 List Sorting Yes Yes Fillable Fileable Form and instruction Attach 22 List Sorting.pdf 20 Imitation Based Assessment of Memory Yes Yes Fillable Fileable Form and instruction Attach 20 Flanker.pdf 19 Bateria III Picture Vocabulary (Spanish only) Yes Yes Fillable Fileable Form and instruction Attach 19 Bateria III Picture Vocabulary.pdf 18 Dimensional Card Change Sort Yes Yes Fillable Fileable Form and instruction Attach 18 Dimensional Change Card Sort.pdf 17 Tactile Discrimination Test Yes Yes Fillable Fileable Form and instruction Attach 17 Tactile Discrimination Test.pdf 9 Pain Assessment Ages 13-17 Yes Yes Fillable Fileable Form and instruction Attach 9 Pain Assessment Ages 13-17.pdf 8 Pain Assessment Ages 8-12 Yes Yes Fillable Fileable Form and instruction Attach 8 Pain Assessment Ages 8-12.pdf 7 Pain Assessment Ages 3-7 Yes Yes Fillable Fileable Form and instruction Attach 7 Pain Asssessment Proxy Ages 3-7.pdf 5 Odor Identification Yes Yes Fillable Fileable Form and instruction Attach 5 Odor Identification Ages 3-9.pdf 55 Text Anxiety Scale Yes Yes Fillable Fileable Form and instruction Attach 55 Test Anxiety Scale (TAS).pdf 57 EtOH (Alcohol) Questionaire No No Fillable Fileable Form and instruction Attach 57 EtOH Questionnaire.pdf 52 PROMIS 29 Participant Yes Yes Fillable Fileable Form and instruction Attach 52 PROMIS 29 - Participant.pdf 51 Pediatric Funtional Assessment of Chronic Illness Therapy Fatigue Yes Yes Fillable Fileable Form and instruction Attach 51 Pediatric Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F).pdf 50 Pediatric PROMIS Physical Function Mobility Yes Yes Fillable Fileable Form and instruction Attach 50 PROMIS Pediatric Physical Function Mobility.pdf 49 Pediatric PROMIS Physical Function Upper Extremity Yes Yes Fillable Fileable Form and instruction Attach 49 PROMIS Pediatric Physical Function Upper Extremity.pdf 47 Pediatric Perceived Cognitive Child Yes Yes Fillable Fileable Form and instruction Attach 47 Pediatric Perceived Cognitive Function (PCF) - Child.pdf 42 Additional Audition Olfaction Taste Yes Yes Fillable Fileable Form and instruction Attach 42 Additional Audition Olfaction Taste Questions.pdf 41 Additional Somatosensation Questions Yes Yes Fillable Fileable Form and instruction Attach 41 Additional Somatosensation Questions.pdf 40 Initial Child/Proxy Questionaire Yes Yes Fillable Fileable Form and instruction Attach 40 Initial Questionnaire-Proxy and Child.pdf 38 Balance Accelerometer Measure Yes Yes Fillable Fileable Form and instruction Attach 38 Balance Accelerometer Measure (BAM).pdf 37 Strength Knee Extension Yes Yes Fillable Fileable Form and instruction Attach 37 Strength Knee Extension.pdf 36 Grip Strength Dynamometry Yes Yes Fillable Fileable Form and instruction Attach 36 Grip Strength Dynamometry.pdf 35 Locomotion 4-meter Walk Test Yes Yes Fillable Fileable Form and instruction Attach 35 Locomotion 4 Meter Walk Test.pdf 34 Endurance 2-Minute Walk Test Yes Yes Fillable Fileable Form and instruction Attach 34 Endurance 2 Minute Walk Test (2MWT).pdf 33 Dexterity 9-hole Pegboard Yes Yes Fillable Fileable Form and instruction Attach 33 9 Hole Pegboard.pdf 32 Supplemental Emotional Health Questionaire Yes Yes Fillable Fileable Form and instruction Attach 32 Supplemental Emotional Health Questionnaires.xls 31 Emotional Health Questionaire Yes Yes Fillable Fileable Form and instruction Attach 31 Emotional Health Questionnaires for Toolbox.xlsx Yes Yes Fillable Fileable Instruction Attach 30 Instructions for Emotional Health Questionnaire.pdf 29 Word Accentuation (Spanish only) Yes Yes Fillable Fileable Form and instruction Attach 29 Spanish Word Accentuation Test.pdf 28 Vocabulary Comprehension Yes Yes Fillable Fileable Form and instruction Attach 28 Vocabulary Comprehension.pdf 27 Handedness Assessment Yes Yes Fillable Fileable Form and instruction Attach 27 Determining Handedness.pdf 26 Reading Recognition Yes Yes Fillable Fileable Form and instruction Attach 26 Reading Recognition.pdf 24 Pattern Comparison Yes Yes Fillable Fileable Form and instruction Attach 24 Pattern Comparison.pdf 15 Brief Kinesthesia Test Yes Yes Fillable Fileable Form and instruction Attach 15 Brief Kinesthesia Test.pdf 14 Vision Health Related QOL Survey Yes Yes Fillable Fileable Form and instruction Attach 14 Vision Health-Related Quality of Life Survey.pdf 13 Dynamic Visual Acuity (DVA) No Yes Fillable Fileable Form and instruction Attach 13 Dynamic Visual Acuity (DVA).pdf 12 Toolbox Taste Test Yes Yes Fillable Fileable Form and instruction Attach 12 Toolbox Taste Test.pdf 11 Sucrose Preference Test Yes Yes Fillable Fileable Form and instruction Attach 11 Sucrose Preference Test.pdf
Individuals or Households 6750 16875 0

Parent Proxies (baseline only + retest) No Health Health Care Services
54 Socio-demographic form Yes Yes Fillable Fileable Form and instruction Attach 54 Sociodemographic Form- Parent.pdf 7 Pain Assessment Ages 3-7 Yes Yes Fillable Printable Form and instruction Attach 7 Pain Asssessment Proxy Ages 3-7.pdf 51 Pediatric Funtional Assessment of Chronic Illness Therapy Fatigue Yes Yes Fillable Fileable Form and instruction Attach 51 Pediatric Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F).pdf 48 Pediatric Perceived Cognitive Proxy Yes Yes Fillable Fileable Form and instruction Attach 48 Pediatric Perceived Cognitive Function (PCF) - Proxy.pdf 44 Health Care Access and Utilization Yes Yes Fillable Fileable Form and instruction Attach 44 Health Care Access and Utilization.pdf 43 Cognition Information Form Yes Yes Fillable Fileable Form and instruction Attach 43 Cognition Information Form.pdf 27 Handedness Assessment Yes Yes Fillable Fileable Form and instruction Attach 27 Determining Handedness.pdf 59 Education Proxy Report for Children Yes Yes Fillable Fileable Form and instruction Attach 59 Education Proxy Report for Children.pdf 40 Initial Child/Proxy Questionaire Yes Yes Fillable Fileable Form and instruction Attach 40 Initial Questionnaire-Proxy and Child.pdf 53 School Performance and Activities Yes Yes Fillable Fileable Form and instruction Attach 53 School Performance and Activities.pdf 8 Pain Assessment Ages 8-12 Yes Yes Fillable Fileable Form and instruction Attach 8 Pain Assessment Ages 8-12.pdf 42 Additional Audition Olfaction Taste Yes Yes Fillable Fileable Form and instruction Attach 42 Additional Audition Olfaction Taste Questions.pdf 41 Additional Somatosensation Questions Yes Yes Fillable Fileable Form and instruction Attach 41 Additional Somatosensation Questions.pdf 32 Supplemental Emotional Health Questionaire Yes Yes Fillable Fileable Form and instruction Attach 32 Supplemental Emotional Health Questionnaires.xls 31 Emotional Health Questionaire Yes Yes Fillable Fileable Form and instruction Attach 31 Emotional Health Questionnaires for Toolbox.xlsx Yes Yes Paper Only Instruction Attach 30 Instructions for Emotional Health Questionnaire.pdf 9 Pain Assessment Ages 8-12 Yes Yes Fillable Fileable Form and instruction Attach 9 Pain Assessment Ages 13-17.pdf
Individuals or Households 6750 3375 0

2011-07-25-04:00

0925-0639 201106-0925-003 0925
             
        "NCI Cancer Genetics Services Directory Web-Based Application and Update Mailer"
             
          
        
The NCI Cancer Genetics Services Directory on NCI's Web site Cancer.gov is a searchable collection of information about professionals who provide services related to cancer genetics (http://www.cancer.gov/cancertopics/genetics/directory). These services include cancer risk assessment, genetic counseling, and genetic susceptibility testing. The professionals have applied to be in the directory using an online application form and have met basic criteria outlined on the form. There are currently 567 genetics professionals listed in the directory. Approximately 30 new professionals are added to the directory each year. The directory has been collecting applications from 1996 through February, 2011 when they were informed to discontinue until OMB approval. The applicants are nurses, physicians, genetic counselors, and other professionals who provide services related to cancer genetics. The information collected on the application form includes name, professional qualifications, practice locations, and the area of specialization. The information is updated annually using a Web-based update mailer that mirrors the application form. The NCI Cancer Genetics Services Directory is a unique resource for cancer patients and their families who are looking for information about their family risk of cancer and genetic counseling. Collecting applicant information and verifying it annually by using the NCI Cancer Genetics Services Directory Application Form and Web-based Update Mailer is important for providing this information to the public and for keeping it current. 2014-08-31-04:00 Active Saleda Perryman No No No 660 180 0

Application for Inclusion in NCI Cancer Genetics Services Directory (PDQ)(R) No Health Illness Prevention
1 Application for Inclusion in NCI Cancer Genetics Services Directory (PDQ?) Yes Yes Fillable Fileable Form Attach 1_Application_CGDirectory.pdf
Individuals or Households 60 30 0

Update Mailer No Health Health Care Services
2 Update Mailer Yes Yes Fillable Fileable Form Attach 3_UpdateMailer_CGDirectory.pdf
Individuals or Households 600 150 0

2011-08-12-04:00

0925-0640 201105-0925-003 0925
             
        "Interactive Diet and Activity Tracking in AARP (iDATA):  Biomarker Based Validation Study (NCI)"
             
          
        
The measurement error structure of the ASA24 and ACT24 needs to be evaluated. The iDATA Study will compare objectively measured energy expenditure, protein, nutrients, and physical activity with the self-reported intakes of energy, protein, nutrients, and physical activity using the ASA24 and ACT24, as well as conventional self-report instruments for assessing diet and physical activity in a free-living population aged 50 to 74 years and residing in the Pittsburgh, Pennsylvania area. To date there has not been a comparable effort to understand the properties and measurement error structure of self-report physical activity instruments. The burgeoning epidemic of obesity highlights the need to explore this in both aspects of energy balance - dietary intake and energy expenditure through physical activity. Other studies have shown significant disagreement between typical, long-term memory-based self-reported activity and objective wearable motion detection devices. To address this, NCI has developed a new internet-based instrument, ACT24, which measures the participant's past 24-hour activities in order to improve the accuracy of self-reported physical activity. Results from previous studies have indicated that multiple 24-hour dietary recalls over the course of one year provide more accurate information about usual dietary exposure and create less bias in estimated risk compared with the typical Food Frequency Questionnaires (FFQ) that asks participants to remember dietary information over the entire past year. An obstacle to the 24-hour recall method is that it is typically administered by interviewers, and is prohibitively expensive to use in large studies, especially multiple administrations. In response, NCI has developed a self-administered internet-based version, ASA24, which allows multiple recalls to be collected at very limited study expense and relatively low participant burden. 2014-08-31-04:00 Active Mikia Currie 3014350941 No No No 34826 15061 0

Att 1 Pre-Screening Telephone Interview No Health Consumer Health and Safety
1 Att 1 Pre-Screening Telephone Interview Yes Yes Fillable Fileable Form Att.1 Pre-Screener Telephone Interview.docx
Individuals or Households 1334 334 0

Att 3 Clinic Eligibility Screening Interview No Health Consumer Health and Safety
2 Att 3 Clinic Eligibility Screening Interview No No Paper Only Form Att.3 Clinic Eilgibility Screening Interview.docx
Individuals or Households 742 124 0

Att 5 Fasting Blood Protocol and Form No Health Consumer Health and Safety
3 Att 5 Fasting Blood Protocol and Form Yes Yes Fillable Fileable Form and instruction Att.5 Fasting Blood Protocol and Form.docx
Individuals or Households 1484 247 0

Att 6 DLW Protocol and Form.doc No Health Consumer Health and Safety
4 Att 6 DLW Protocol and Form.doc Yes Yes Fillable Fileable Form Att.6 DLW Protocol and Form.doc
Individuals or Households 776 517 0

Att 7 RMR Protocol No Health Consumer Health and Safety
5 Att 7 RMR Protocol Yes Yes Fillable Fileable Form and instruction Att.7 RMR Protocol.doc
Individuals or Households 776 388 0

Att 8 Heart Rate Monitor Log No Health Consumer Health and Safety
6 Att.8 Heart Rate Monitor Log No No Paper Only Form and instruction Att.8 Heart Rate Monitor Log.docx
Individuals or Households 34 20 0

Att 10 FitnessTest protocol No Health Consumer Health and Safety
7 Att 10 FitnessTest protocol Yes Yes Fillable Fileable Form Att.10 FitnessTest protocol.doc
Individuals or Households 742 186 0

Att.11A and 11B PARQ PARmedX No Health Consumer Health and Safety
8 Att.11A and 11B PARQ PARmedX Yes Yes Fillable Fileable Form Att.11A and 11B PARQ PARmedX.pdf
Individuals or Households 742 62 0

Att.12 PA Monitor Log No Health Consumer Health and Safety
9 Att.12 PA Monitor Log No No Paper Only Form and instruction Att.12 PA Monitor Log.doc
Individuals or Households 1484 866 0

Att.13 Anthropometry No Health Consumer Health and Safety
10 Att.13 Anthropometry Yes Yes Fillable Fileable Form Att.13 Anthropometry.doc
Individuals or Households 2226 371 0

Att.14 24 hr Urine Collection Log No Health Consumer Health and Safety
11 Att.14 24 hr Urine Collection Log No No Paper Only Form and instruction Att.14 24 hr Urine Collection Log.doc
Individuals or Households 1484 1484 0

Att.15 Saliva collection instructions No Health Consumer Health and Safety
12 Att.15 Saliva collection instructions No No Paper Only Form and instruction Att.15 Saliva collection instructions.doc
Individuals or Households 2226 371 0

Att.16 7-Day Food Checklist iDATA No Health Consumer Health and Safety
13 Att.16 7-Day Food Checklist iDATA Yes Yes Paper Only Form and instruction Att.16 7-Day Food Checklist iDATA.pdf
Individuals or Households 1484 1484 0

Att.17 4 Day Food Record iDATA No Health Consumer Health and Safety
14 Att.17 4 Day Food Record iDATA No No Paper Only Form and instruction Att.17 4 Day Food Record iDATA.pdf
Individuals or Households 1484 1484 0

Att.18 Harvard Lifestyle Questionnaire for iDATA No Health Consumer Health and Safety
15 Att.18 Harvard Lifestyle Questionnaire for iDATA Yes Yes Fillable Fileable Form Att.18 Harvard Lifestyle Questionnaire for iDATA.pdf
Individuals or Households 1484 247 0

Att.19 CHAMPS Activities Questionnaire No Health Consumer Health and Safety
16 Att.19 CHAMPS Activities Questionnaire Yes Yes Fillable Fileable Form Att.19 CHAMPS Activities Questionnaire.doc
Individuals or Households 1484 371 0

Att.20 AARP Physical Activity questions No Health Consumer Health and Safety
17 Att.20 AARP PA questions Yes Yes Fillable Fileable Form Att.20 AARP PA questions.doc
Individuals or Households 1484 247 0

Att.21 Sedentary Behavior Questionnaire No Health Consumer Health and Safety
18 Att.21 Sedentary Behavior Questionnaire Yes Yes Fillable Fileable Form Att.21 Sedentary Behavior Questionnaire.docx
Individuals or Households 1484 495 0

Att.22 Stanford Physical Activity Screener No Health Consumer Health and Safety
19 Att.22 Stanford Physical Activity Screener Yes Yes Fillable Fileable Form Att.22 Stanford Physical Activity Screener.doc
Individuals or Households 1484 198 0

Att.32 ASA24 No Health Consumer Health and Safety
20 Att.32 ASA24 https://asa24.westat.com Yes Yes Fillable Fileable Form Att.32 ASA24.docx
Individuals or Households 4452 2226 0

Att.33 DHQ No Health Consumer Health and Safety
21 Att.33 DHQ http://riskfactor.cancer.gov/dhq2/webquest/ Yes Yes Fillable Fileable Form Att.33 DHQ.docx
Individuals or Households 1484 1113 0

Att.34 ACT24 No Health Consumer Health and Safety
22 Att.34 ACT24 http://act24demo.westat.com Yes Yes Fillable Fileable Form Att.34 ACT24.docx
Individuals or Households 4452 2226 0

2011-08-25-04:00

0925-0641 201106-0925-002 0925
             
        "Generic Submission for Formative Research, Pre-testing, Stakeholder Measures and Advocate Forms at NCI"
             
          
        
This is a request for OMB to approve this generic submission package on behalf of the NCI Office of Advocacy Relations (OAR). In addition to collecting information for research and customer service, OAR will request information from advocates in order to match them appropriately to NCI activities based on their interest and experience. Approval is requested for the conduct of multiple studies annually using such methods as interviews, focus groups, and various types of surveys. 2014-09-30-04:00 Active Mikia Currie 3014350941 No No No 5925 3675 0 2011-09-01-04:00

0925-0642 201108-0925-002 0925
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery"
             
          
        
This collection of information is necessary to enable NIH to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with NIH's programs. 2014-09-30-04:00 Active Mikia Currie 3014350941 No No No 6500 8750 0

Sub-study #1_The Cancer Genome Atlas (TCGA) Data User Platform Survey No Health Consumer Health and Safety
1A TCGA Email and Survey Yes Yes Fillable Fileable Form and instruction #1_Attach 1A_Survey_10-5-2011.doc
Individuals or Households 220 4 0

Revised Bundled Sub-study #2 and #3_Usability Testing for DCEG Newsletter Linkage and SEER Consolidated Cancer Statistics Tool No Health Consumer Health and Safety
3F SEER Moderator Guide for Media Yes No Printable Only Form and instruction #3_SEER_Attach F_Guide Media.docx 3D SEER Moderator Guide for HC Professionals Yes No Printable Only Form and instruction #3_SEER_Attach D_Guide Health Professional.docx 3E SEER Moderator Guide for Researcher Yes No Printable Only Form and instruction #3_SEER_Attach E_Guide Researcher.docx 3C SEER Moderator Guide for Public Yes No Printable Only Form and instruction #3_SEER_Attach C_Guide Public.doc 3A and 3B SEER Screener for HC Prof and Public Yes No Printable Only Form and instruction #3_SEER_Attach A&B_Screener for Health Prof and Public.doc 2.1 and 2.5 DCEG Facilitator's Guide and System Usability Scale Yes No Printable Only Form and instruction #2_DCEG_Attach 1 & 5_Facilitator Guide and SUS.doc
Individuals or Households 42 43 0

Sub-study #4_Multi-Part Plan for Research and Development of the Solar Cell Mobile Application No General Science and Innovation Scientific and Technological Research and Innovation
4 Attach 8 MP Interviews Guide & Questions Yes No Printable Only Form and instruction #4_SC_Attach8_medprofinterviews_questions.docx 2 Attach 4 CogInterview Screen & Pre-and Post-tests Yes No Printable Only Form and instruction #4_SC_Attach4_REVISE_coginter_screen_preposttests.docx 5 Attach 10 Use Test Interview Guide & Questions Yes No Printable Only Form and instruction #4_SC_Attach10_androidusabilitytest_questions.docx 1 Attach 2 Beta Test Screen & Survey Yes No Printable Only Form and instruction #4_SC_Attach2_betatest_screen_survey.docx 3 Attach 6 Focus Group Screen & Questions Yes No Printable Only Form and instruction #4_SC_Attach6_REVISE_focusgroup_screen_questions.docx
Individuals or Households 195 68 0

Bundled Sub-studies #5 DCP Survey, #6 R2R Survey, and #7 PS-OC Survey No Health Consumer Health and Safety
3B #7_Attach2B_Education Yes Yes Fillable Fileable Form and instruction #7_OSPO_Attach 2B_Education and Training Unit Leaders (Sections A and E).pdf 3A #7_Attach 2A_Administrators Yes Yes Fillable Fileable Form and instruction #7_OSPO_Attach 2A_Administrators (Section A).pdf 3F #7_Attach2F_Advocates Yes Yes Fillable Fileable Form and instruction #7_OSPO_Attach 2F_Advocates (Section F).pdf 3D #7_Attach2D_Project Investigators Yes Yes Fillable Printable Form and instruction #7_OSPO_Attach 2D_Project Investigators (Sections C & J).pdf 3G #7_Attach2G_Advisors Yes Yes Fillable Fileable Form and instruction #7_OSPO_Attach 2G_External Advisors & Scientists Not Associated (Section G).pdf 3E #7_Attach2E_Outreach Yes Yes Fillable Fileable Form and instruction #7_OSPO_Attach 2E_Outreach and Education Unit Leaders (Section D).pdf 3H #7_Attach2H_Trainees Yes Yes Fillable Fileable Form and instruction #7_OSPO_Attach 2H_Trainees (Sections H &J).pdf 2 R2R Survey Yes Yes Fillable Fileable Form and instruction #6_Attach 1_R2R Survey _Screenshots_1-30-12.docx 1 DCP Survey Screenshots Yes Yes Fillable Fileable Form and instruction #5_Attach 2_DCP_Survey_Screenshots.pdf 3C #7_Attach2C_Principal Yes Yes Fillable Fileable Form and instruction #7_OSPO_Attach 2C_Principal and Scientific Investigators (Sections B & J).pdf
Individuals or Households 2217 351 0

Sub-study #8_HD*Calc Customer Satisfaction Survey for Private Sector Respondents No Health Consumer Health and Safety
1 Full Survey with Skips Yes Yes Fillable Fileable Form and instruction _8_Attach_2_Full_Survey_with_identified_skips_HD_Calc[1].docx
Private Sector 19 3 0

Sub-Study #9 & #10 - HD*Calc Customer Satisfaction Survey for Different Category of Respondents: State (#9) and Federal Respondents (#10) No Health Consumer Health and Safety
1 HD Calc Survey Yes Yes Fillable Fileable Form and instruction Attach 2_Full Survey with identified skips_HD Calc.docx
Federal Government 7 1 0

Sub-studies #11 & #12 - Web-based Surveys of Cancer Research in Media 2010 Workshop (#11) & Smokefree.gov Users (#12) No Health Consumer Health and Safety
5 #12 Smokefree.gov Screenshots Part 2 Yes Yes Fillable Fileable Form and instruction #12_Attach 1B_TCRB Screenshot_5-8-2012.jpg 1 Follow-Up Survey_English Yes Yes Fillable Fileable Form and instruction #11_Attach11B_Follow-up Survey_English.docx 2 Follow-Up Survey_Portuguese Yes Yes Fillable Fileable Form and instruction #11_CRIM_Attach11C_Follow-up Screenshots_Portuguese.doc 3 Follow-Up Survey_Spanish Yes Yes Fillable Fileable Form and instruction #11_CRIM_Attach11D_Follow-up Screenshots_Spanish.docx 4 #12 Smokefree.gov Screenshots Part 1 Yes Yes Fillable Fileable Form and instruction #12_Attach 1A_TCRB Screenshot_5-8-2012.jpg
Individuals or Households 3025 256 0

Sub-study #13 - Focus Groups to Assess Implementation of the NCCCP-developed Template for Community Outreach (TCO) No Health Illness Prevention
1 Moderator's Guide No No Printable Only Form and instruction #13_Attach 2_TCO Moderator Guide .docx
Private Sector 15 23 0

Sub-study #14 - CCR Clinical Trials at NIH - Join Our Mailing List/Update Your Profile Business Contact Information No Health Consumer Health and Safety
2 Update CCR Mailing List Yes Yes Fillable Fileable Form and instruction #14_Attach 2_Update Your Profile.doc 1 Join CCR Mailing List Yes Yes Fillable Fileable Form and instruction #14_Attach 1_Join Our Mailing List.doc
Individuals or Households 1600 133 0

Sub-Study #15: The Surveillance, Epidemiology, and End Results (SEER) Residual Tissue Repository Program: Survey to Assess Service Delivery and Product Quality No Health Consumer Health and Safety
1 RTR Survey Yes Yes Fillable Fileable Form and instruction #15_Attach 3_RTR survey screenshots.pdf
Individuals or Households 72 6 0

Sub-Study #16 - International Focus Group to Inform Economic Barriers and Challenges to Biobankers No Health Public Health Monitoring
1 Moderator's Guide No No Printable Only Form and instruction #16_Attach_2_ModeratorGuide_BBRB.docx
Private Sector 25 38 0

Sub-study #18_Cancer Imaging Program (CIP) Web Site Usability Testing No Health Consumer Health and Safety
2 Usability Test No No Printable Only Form and instruction Attach5_UsabilityScript_CIP.doc 1 Screener No No Printable Only Form and instruction Attach4_Screener_CIP.docx
Individuals or Households 74 28 0

Sub-study #19_Epidemiology and Genomics Research Program (EGRP) Communications Survey No Health Consumer Health and Safety
1 EGRP Listserv Survey Yes Yes Fillable Fileable Form and instruction Attachment 2 - EGRP Communications Survey 12 5 12.pdf
Federal Government 2000 333 0

Bundled Sub-studies #20, #21 and #22 Website Usability Testing No Health Consumer Health and Safety
1 CPCC #20 Screener Yes No Printable Only Form and instruction CPCC_#20_Attach2 Recruitment Screener.docx 2 CPCC #20 Facilitator's Guide Yes No Printable Only Form and instruction CPCC_#20_Attach5 Facilitator's Guide Final.doc 3 DCPDIV #21 Screener Yes No Printable Only Form and instruction DCP Div_#21_Attach2 Recruitment Screener.docx 4 DCPDIV #21 Facilitator's Guide Yes No Printable Only Form and instruction DCP Div_#21_Attach3 Facilitator's Guide.doc 5 DCP NSRG Screener Yes No Printable Only Form and instruction DCP NSRG_#22_Attach2 Recruitment Screener.docx 6 DCP NSRG Facilitator's Guide Yes No Printable Only Form and instruction DCP NSRG_#22_Attach3 Facilitator's Guide.doc
Individuals or Households 132 72 0

Sub-study #23 NCCOR Website Usability Testing No Health Consumer Health and Safety
2 Facilitator's Guide - Measures No No Printable Only Form and instruction NCCOR_#23_Attach_5 Facilitator's guide Measures_2-19-2013.docx 1 Facilitator's Guide - Catalogue No No Printable Only Form and instruction NCCOR_#23_Attach_4 Facilitator's guide Catalogue Surv_2-19-2013_REV.docx 3 Recruit Phone Call No No Printable Only Form and instruction NCCOR_#23_Attach_6 Fup Recruit Phone call_2-19-2013.docx
Individuals or Households 91 54 0

Sub-study #26_Life in A Day Phone Application Study (Usability Study) No Health Consumer Health and Safety
1 Screener_Life No No Printable Only Form and instruction Attach1_Life in a Day_Screener.docx 2 Day 1 Script No No Printable Only Form and instruction Attach2_Day1_Initial interview script_Life.docx 3 Day 3 Script No No Printable Only Form and instruction Attach3_Day3_Followup interview script_Life.docx
Individuals or Households 61 46 0

Sub-study #24 - Needs Assessment for the NCI Office of Cancer Survivorship's Web site (OCS) No Health Consumer Health and Safety
2 OCS Screener for Professionals No No Printable Only Form and instruction OCS_#24_Attach3 Screener for Professionals_4-10-2013.docx 1 OCS Screener for Public No No Printable Only Form and instruction OCS_#24_Attach1 Screener for Public_4-10-2013.doc 3 Facilitator's Guides for All Groups No No Printable Only Form and instruction OCS_#24_Attach6 Facilitator's Guide All Audiences_4-10-2013.doc
Individuals or Households 120 66 0

REVISED Sub-study #25_ Center for Cancer Training (CCT) Web Site Usability Testing No Health Consumer Health and Safety
2 CCT Usability Script No No Printable Only Form and instruction CCT_#25_Attach3_Usability_Script_CCT.doc 1 CCT Screener No No Printable Only Form and instruction CCT_#25_Attach1_Screener_REV.docx
Individuals or Households 66 24 0

Sub-study #27_Satisfaction with Cancer Research Programs in Underserved Communities (CGH) No Health Consumer Health and Safety
1 Facilitator Conducted Survey No No Printable Only Form and instruction Attach1_CGH_Survey_5-3-2013.doc
Individuals or Households 150 50 0

Sub-study #28_Customer Satisfaction and Feedback about the NCI Best Practices for Biospecimen Resources No Health Consumer Health and Safety
1 BBRB Standards Survey Yes Yes Fillable Fileable Form and instruction Attachment1_BBRB_SurveyOMB_5-14-2013.docx
Individuals or Households 1000 167 0

Sub-study #29_Satisfaction with Global Cancer Research Day 2013 No Health Consumer Health and Safety
1 CGH Global Meeting Survey Yes Yes Fillable Fileable Form and instruction Attach2_GlobalDaySurvey.pdf
Individuals or Households 120 20 0

Sub-study #32_Protocol and Information Office (PIO) External Customer Satisfaction Survey No Health Consumer Health and Safety
1 PIO Survey Yes Yes Fillable Fileable Form and instruction Attachment 1_PIO External Survey.docx
Individuals or Households 100 8 0

Sub-study #33_User Simulation Study for NIH-SSA Collaboration to Improve Disability Determination (Revised) No Income Security General Retirement and Disability
4 Debriefing Interview for Feds No No Printable Only Form and instruction Attach E_REVISED Debriefing Interview Questions for Feds.doc 3 Initial Screenshot of CAT Yes Yes Fillable Fileable Form and instruction Attach C_ CAT Instrument Screen Shot.doc 1 Item Bank Behavioral Health Questions Yes Yes Fillable Fileable Form and instruction Attach A_REVISED_All Behavioral Health CAT Items_11-5-2013.doc 2 Item Bank Physical Function Questions Yes Yes Fillable Fileable Form and instruction Attach B_REVISED_All PF CAT Items_11-5-2013.doc
Individuals or Households 125 63 0

Sub-study #34_NCI Office of Cancer Nanotechnology Laboratory (caNanoLab) Survey No General Science and Innovation Scientific and Technological Research and Innovation
1 Survey Yes Yes Fillable Fileable Form and instruction Attachment B_caNanoLab Survey.pdf
Individuals or Households 60 10 0

Sub-study #35_Cognitive Interviewing for Item Bank in Computer Adaptive Testing Instrument No Health Consumer Health and Safety
2 Consent Form Yes No Printable Only Form and instruction Attachment 4_Consent_Cog Testing_OMB.pdf 1 Moderator's Guide Yes No Printable Only Form and instruction Attachment 3_CogIntervModerator Guide.docx
Individuals or Households 140 76 0

#36 Clinical Proteomic Tumor Analysis Consortium (CPTAC) Surveys No Health Consumer Health and Safety
2B CPTAC Survey screenshots Yes Yes Fillable Fileable Form and instruction Attach2B_ Survey_CPTAC_Screenshots.docx 1B TCGA Survey Screenshots Yes Yes Fillable Fileable Form and instruction Attach1B_Survey_TCGA_Screenshots.docx
Individuals or Households 300 50 0

2011-09-20-04:00

0925-0643 201110-0925-003 0925
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NICHD)"
             
          
        
This collection of information is necessary to enable the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with NICHD's programs. 2014-10-31-04:00 Active Mikia Currie 3014350941 No No No 45600 14850 0

Back to Sleep Brand Identity Testing No Health Health Care Services
1 Screener No No Paper Only Form and instruction Back To Sleep Screener for Caregivers_0925-0643.docx 2 Moderators Guide Yes Yes Paper Only Form and instruction Back To Sleep Moderators Guide for Caregivers_0925-0643[1].docx
Individuals or Households 54 122 0

Back to Sleep Brand Identity Testing No Health Health Care Services
2 Moderators Guide Yes Yes Paper Only Form and instruction Back To Sleep_Attachment B_Moderators Guide for Private Sector Health Professionals_0925-0643.docx 1 Screener Yes Yes Paper Only Form and instruction Back To Sleep_Attachment A_Screener for Private Sector Health Professionals_0925-0643.docx
Private Sector 23 52 0

Back to Sleep Brand Identity Testing No Health Health Care Services
2 Moderators Guide Yes Yes Paper Only Form and instruction Back To Sleep_Attachment B_Moderators Guide for State-Local-Tribal Health Professionals_0925-0643.docx 1 Screener Yes Yes Paper Only Form and instruction Back To Sleep_Attachment A_Screener for State-Local-Tribal Health Professionals_0925-0643.docx
State, Local, and Tribal Governments 23 52 0

Non-Medically Indicated Induction Prior to 39 Weeks of Gestation Focus Groups No Health Health Care Services
1 Screener Yes Yes Paper Only Form and instruction Pre-term_birth_recruitment_screener_0925-0643.docx 3 Pregnant Women Yes Yes Paper Only Form and instruction Pre-term_Birth_Telephone_Focus_Group_Guide_pregnant_women_0925-0643_rev 4-10-12.docx 2 Focus Group fathers Yes Yes Paper Only Form and instruction Pre-term_Birth_Telephone_Focus_Group_Guide_fathers_0925-0643_rev 4-10-12.docx
Individuals or Households 45 68 0

Safe to Sleep Campaign Focus Groups with the Breastfeeding/Lactation Support Community No Health Health Care Services
2 Moderator's Guide for Breastfeeding Women No No Paper Only Form and instruction NICHD_focus_group_breastfeeding_women_MODERATOR_GUIDE.docx 1 Recruitment Screener for Breastfeeding Women No No Paper Only Form and instruction NICHD_focus_group_breastfeeding_women_RECRUITMENT_SCREENER.docx 3 Recruitment Screener for Pregnant Women No No Paper Only Form and instruction NICHD_focus_group_pregnant_women_RECRUITMENT_SCREENER.docx 4 Moderator's Guide for Pregnant Women No No Paper Only Form and instruction NICHD_focus_group_pregnant_women_MODERATOR_GUIDE.docx
Individuals or Households 18 18 0

Nurses' Continuing Education Program on Sudden Infant Death Syndrome (SIDS)--Customer Satisfaction Survey No Health Health Care Services
1 Nurse CE Program Survey Yes Yes Fillable Fileable Form and instruction NICHD Nurse CE Program Survey_12 13.pdf
Private Sector 18400 4600 0

NICHD Postpartum Depression (PPD) Focus Groups No Health Health Care Services
7 Recruitment Screener PPD Moms No No Paper Only Form and instruction 0925-0643_RECRUITMENT_SCREENER_PPD MOMS_final.docx 6 Recruitment Screener Mom telephone focus group No No Paper Only Form and instruction 0925-0643_RECRUITMENT_SCREENER_GENERAL MOMS_TELEPHONE FOCUS GROUPS_final.docx 5 Moderators Guide PPD Moms No No Paper Only Form and instruction 0925-0643_MODERATOR_GUIDE_PPD MOMS_final.docx 4 Moderators Guide general mom No No Paper Only Form and instruction 0925-0643_MODERATOR_GUIDE_GENERAL MOMS_final.docx 3 Moderator Guide Fathers No No Paper Only Form and instruction 0925-0643_MODERATOR_GUIDE_FATHERS_final.docx 2 Recruitment Screener Mom In-person Focus Group No No Paper Only Form 0925-0643_RECRUITMENT_SCREENER_GENERAL MOMS_IN-PERSON FOCUS GROUP_final.docx 1 Recruitment Screener Fathers No No Paper Only Form 0925-0643_RECRUITMENT_SCREENER_FATHERS_final.docx
Individuals or Households 96 108 0

2011-10-31-04:00

0925-0644 201108-0925-001 0925
             
        "Simulations for Drug Related Science Education (NIDA)"
             
          
        
This is a request to evaluate an interactive multimedia module developed by ArchieMD. This evaluation seeks to determine whether the multimedia module Archie MD: The Science of Drugs (1) Increases students' knowledge in brain and heart biology and the effects drugs have on the body (2) Increases positive attitudes towards science education for high school students (3) Reinforce or instill negative attitudes towards substance abuse. In order to test the effectiveness of the interactive multimedia module, data will be collected in the form of pre and post test surveys from 10th and 11th grade high school students utilizing the developed module. The findings will provide valuable information regarding information pertaining to the use of interactive multimedia educational modules in high school science classrooms and their ability to increase knowledge and change attitudes and perceptions. 2014-10-31-04:00 Active Saleda Perryman No No No 1080 450 0

High School Students No Education Elementary, Secondary, and Vocational Education
1 Pre Test Yes Yes Fillable Fileable Form and instruction Pre-Test Appendix1v7 20 11.doc 2 Post Feedback Questionaire Yes Yes Fillable Fileable Form and instruction Post Feedback Questions appendix2v7 20 11.doc
Individuals or Households 1080 450 0

2011-10-31-04:00

0925-0645 201111-0925-003 0925
             
        "A Generic Submission for Theory Development and Validation (NCI)"
             
          
        
In order to carry out NCI's legislative mandate to conduct and support research with respect to the causes and prevention of cancer, it is beneficial for NCI, through initiatives in the Behavioral Research Program (BRP), to conduct and support behavioral research informed by and informing theory. Formative research in the area of theory development and validation would provide the basis for developing effective cancer prevention and control strategies, allow for a better understanding of theoretical constructs that influence decisions and actions related to cancer, and ultimately contribute to reducing the U.S. cancer burden. Data collections that result from this generic clearance would inform and clarify the use of theory in BRP-supported initiatives and funding announcements. Specifically, this research would allow NCI to conduct research to: 1) Identify psychological, biobehavioral, demographic, and individual difference predictors of cancer prevention and control behaviors and outcomes; 2) Develop and refine integrative theories; 3) Identify and observe theoretical and innovative trends in cancer prevention and control research; and 4) Determine feasibility and usefulness of collaborative and multidisciplinary approaches to cancer prevention and control. Respondents will be members of the public including, but not limited to, health professionals, physicians, and researchers. 2014-12-31-05:00 Active Saleda Perryman No No No 11500 6000 0

Sub-study #1_Self-Affirmation and Affect No Health Consumer Health and Safety
1 Self-Affirmation Survey Yes Yes Fillable Fileable Form and instruction #1_Attach 1A_Self-Affirm Suvey.doc
Individuals or Households 800 400 0

Sub-study #3 Self-Affirmation REVISED No Health Consumer Health and Safety
1 Self-Affirm Survey Yes Yes Fillable Fileable Form and instruction #3B_Attach_Self- Affirm Survey_Screenshots.doc
Individuals or Households 250 125 0

Sub-Study #2_Informed Consent and Incidental Emotion No Health Consumer Health and Safety
2 Questionnaire (Screenshots) Yes Yes Fillable Fileable Form and instruction #2Cii_Attach_IC_Questionnaire-ScreenShots.docx 1 Screener No No Printable Only Form and instruction #2F_Attach_IC_Screener.doc
Individuals or Households 520 287 0

Sub-study #4_Alternative Tobacco Products Study No Health Consumer Health and Safety
5 Moderators Guide and Interview No No Printable Only Form and instruction E2_Moderator Guide Final ET 5-31-2013.docx 3 Eye Tracking Survey Yes Yes Fillable Fileable Form and instruction D_Eye Tracking Questionnaire_5-31-2013.doc 4 Moderator Guide & Focus Group No No Printable Only Form and instruction E1_Moderator Guide Final ET+FG 5-31-2013.docx 2 and 3 Attachment B and D Screenshots Yes Yes Fillable Printable Form and instruction B&D Screenshots Baseline & Eye Track Qx_5.31.13[1].pdf 2 Baseline Survey Yes Yes Fillable Fileable Form and instruction B_Baseline Questionnaire 5-6-2013.doc 1 Screener No No Printable Only Form and instruction G_Screeners 5-31-2013.docx
Individuals or Households 192 72 0

Sub-study #5_Patient Perspectives and Simulated Clinical Interactions No Health Consumer Health and Safety
1 Simulated Clinical Interaction Survey Yes Yes Fillable Fileable Form and instruction Attach5B_Questionniare_Screenshots.pdf
Individuals or Households 700 350 0

Sub-study #6_Validating scale to assess cancer-related risk perceptions No Health Consumer Health and Safety
2 Survey 2 Yes Yes Fillable Fileable Form and instruction #6 Attachment 6C Survey 2.pdf 3 Survey 3 Yes Yes Fillable Fileable Form and instruction #6 Attachment 6D Survey 3.pdf 1 Survey 1 Yes Yes Fillable Fileable Form and instruction #6 Attachment 6B Survey 1.pdf
Individuals or Households 1500 625 0

2011-12-12-05:00

0925-0647 201109-0925-001 0925
             
        "Biospecimen and Physical Measurements Formative Research Methodology Studies for the National Children?s Study (NICHD)"
             
          
        
Faced with the challenge of how to address the potential risks of many environmental factors that may be affecting the health and development of children, the President's Task Force on Health Risks and Safety Risks to Children concluded in 1999 that a large study to define the actual risks associated with broad environmental exposures is an essential first step. Following the recommendation of the task force, the U.S. Congress passed the Children's Health Act of 2000 which directed the National Institute of Child Health and Human Development (NICHD) to conduct a national longitudinal study of environmental influences (including physical, chemical, biological, and psychosocial influences) on children's health and development. The National Institute of Environmental Health Sciences (NIEHS), the Centers for Disease Control and Prevention (CDC), and the U.S. Environmental Protection Agency (EPA) joined the NICHD in planning the study. 2015-01-31-05:00 Active Saleda Perryman No No No 113000 60000 0

Methods of Biospecimen Collection for Women, Infants and Children No Health Health Care Services Individuals or Households 1125 234 0

LOI2-BIO-19 - Integration of salivary analytes into the NCS: Evaluation of Feasibility, Efficiency, and Benefits No General Science and Innovation Scientific and Technological Research and Innovation
Yes Yes Paper Only Instruction Attach S4 Goal 2_Saliva Collection Do's and Don'ts.docx 2.2 Goal 2 Home Visit Demographics Yes Yes Fillable Printable Form and instruction Attach 2c Goal 2_Home Visit Demographics Questionnaire.docx 1.3 Goal 1 Demographic and Health Yes Yes Fillable Fileable Form and instruction Attach 1d Goal 1_Demographic Health Behavior Questionnaire.doc Yes Yes Paper Only Instruction Attach S5 Goal 2_Sample Shipping Instructions.docx Yes Yes Paper Only Instruction Attach S3 Goal 2_Saliva Collection Diagrams.docx 2.4 Goal 2 Saliva Collection Log Yes Yes Fillable Printable Form and instruction Attach S2 Goal 2_DemoMotherInfantChild Saliva Collection Sheets.docx Yes Yes Paper Only Instruction Attach S1 Goal 2_Home Visit Saliva Collection Guide.docx 2.3 Goal 2 Follow-Up Telephone Interview Yes Yes Paper Only Form and instruction Attach 2d Goal 2_ Follow Up Telephone Interview.docx 2.1 Goal 2 Telephone Screening Script Yes Yes Paper Only Form and instruction Attach 2a Goal 2_TelephoneScreeningScript.docx 1.1 Goal 1 Telephone Screening Script Yes Yes Paper Only Form and instruction Attach 1b Goal 1_TelephoneScreeningScript.docx
Individuals or Households 2362 495 0

LOI3-RT-01-N GC/MS methods to determine environmental factors on fetal and newborn gene expression No General Science and Innovation Scientific and Technological Research and Innovation Individuals or Households 1300 150 0

2012-01-05-05:00

0925-0648 201112-0925-001 0925
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (OD/OER)"
             
          
        
This collection of information is necessary to enable the National Institutes of Health to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the agency's programs. 2015-01-31-05:00 Active Saleda Perryman No No No 759000 148074 0

Focus Groups on Interlibrary Loan/Resource Sharing Needs in the National Network of Libraries of Medicine No Health Health Care Services
1 Focus Groups Yes Yes Printable Only Form and instruction NLM Survey Instrument_ Focus Group Questions Revised.docx
Private Sector 27 27 0

NIAMS KAI's Client Survey No Health Health Care Services
1 Survey Yes Yes Fillable Printable Form and instruction NIAMS Client Survey through Survey Monkey Update 09Apr2012.docx
Individuals or Households 29 5 0

National Multicultural Outreach Initiative (NMOI) Pilot Study No Health Health Care Services
1 Health Planner Survey Yes Yes Fillable Printable Form and instruction Health Planner Survey Monkey Screen shots 04 17 12.docx
Individuals or Households 700 233 0

Practicum Participant Survey No Health Health Care Services
1 Practicum Participant Survey Yes Yes Fillable Fileable Form and instruction Practicum Survey Screen Shots_03202012.docx
Individuals or Households 381 159 0

OBSSR Online Card Sort No Health Health Care Services
1 Online Card Sort Yes Yes Fillable Fileable Form and instruction OBSSR Online CardSort_Screens.docx
Individuals or Households 50 8 0

Comment Card for Soliciting Feedback on NEI Public Inquiry Response No Health Health Care Services
1 Comment Card Yes Yes Paper Only Form and instruction Survey instrument-NEI 05-01-12.docx
Individuals or Households 4200 350 0

ONLINE SURVEY FOR NIDCD INSIDE NEWSLETTER No Health Health Care Services
1 Online Survey No Yes Fillable Fileable Form and instruction NIDCD Inside Survey Screenshots.pdf
Individuals or Households 284 71 0

Semi-structured telephone interview for end users who are stakeholders in PROMIS No Health Health Care Services
1 Survey Yes Yes Printable Only Form and instruction PROMIS Semi-structured Interview Questions FINAL.docx
Individuals or Households 15 10 0

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Customer Satisfaction Survey No Health Health Care Services
1 Survey Yes Yes Paper Only Form and instruction CSS OMB Submission questions v2.docx
Individuals or Households 1800 60 0

Requirements Gathering for Patient-Centered Communication (PCC) Web-based Application for NCI No Health Health Care Services
3 Patient Protocol Yes Yes Printable Only Form and instruction _2_Attach_6_PatienProtocol_PCCUsability.doc 5 System Usability Scale Yes Yes Printable Only Form and instruction #2_Attach_8_SUScale.docx 2 Individual Interviews Moderator's Guide Yes Yes Printable Only Form and instruction _1_Attach_2_Provid_Inter_Guide_PCC_Require.docx 1 Group Interviews Moderator's Guide Yes Yes Printable Only Form and instruction _1_Attach_1_Group_Inter_Guides_PCC_Require[1].docx 4 Support Person Protocol Yes Yes Printable Only Form and instruction _2_Attach_7_SupportProtocol_PCCUsability.doc
Individuals or Households 65 65 0

Web-based Survey of DIRLINE database (NLM) No Health Public Health Monitoring
1 NLM Survey Instument Yes Yes Printable Only Form and instruction NLM DIRLINE_survey instrument_fast track request (2).docx
Private Sector 150 13 0

NLM Routine Customeer Feedback Collection No Health Public Health Monitoring
1B Routine Customer Feedback Form (Screenshots) Yes No Fillable Printable Form NLM Email_Web Customer Service Screenshots 7.2012 FINAL.pdf 1 Routine Customer Feedback Form Yes Yes Fillable Printable Form NLM Customer Service Satisfaction Survey 2012 7.2012 FINAL.doc
Individuals or Households 500 42 0

NLM IndexCat User Survey No Health Health Care Services
1 NLM Cat Index Cat Survey (Screenshots) Yes Yes Fillable Fileable Form and instruction NLM HMD IndexCat Survey Screen Shot.pdf
Private Sector 200 17 0

NIH Office of the Ombudsman, Center for Cooperative Resolution, user feedback survey No Health Health Care Services
1 Online Survey Yes Yes Fillable Fileable Form and instruction NIHOmbuds_usersurvey_screenshot_3.doc
Individuals or Households 300 50 0

Survey on Interlibrary Loan/Resource Sharing Needs in the National Network of Libraries of Medicine, 2013 No Health Health Care Services
1 Survey Yes Yes Fillable Fileable Form and instruction NLM_LO Survey Instrument_ SurveyMonkey Questions.pdf
Private Sector 2100 420 0

NCI Epidemiology and Genomics Research Program (EGRP) Sequencing Meeting Planning Survey No Health Health Care Services
1 EGRP Meeting Yes No Fillable Fileable Form and instruction Attach 2_EGRP_Meeting_Survey.doc
Individuals or Households 60 10 0

Loan Repayment Program Survey: Renewal Application Process No Health Health Care Services
1 LRP Screenshots Yes Yes Fillable Fileable Form and instruction Attachement 3 - LRP Renewal Application Process Screenshots.pptx
Individuals or Households 60 5 0

NCAAM Clearinghouse Telephone Survey No Health Health Care Services
1 NCAAM Clearinghouse Telephone Survey Yes Yes Paper Only Form and instruction APPENDIX A Survey Instrument- rev 4.1.2013.doc
Individuals or Households 275 23 0

It's a Noisy Planet. Protect Their Hearing. Campaign: Customer Satisfaction Survey No Health Health Care Services
2 Parent Survey Yes Yes Fillable Fileable Form and instruction Parent_Survey_Screenshots.pdf 1 Customer Satisfaction Survey Yes Yes Fillable Fileable Form and instruction Customer_Satisfaction_Survey_Screenshots.pdf
Individuals or Households 550 105 0

User Survey for IHM database and website No Health Health Care Services
1 IHM Survey Yes Yes Fillable Fileable Form and instruction NLM IHM SurveyMonkey screen shot.pdf
Private Sector 100 8 0

NCCAM Customer Service Data Collection for the NCCAM Clinical Digest e-Newsletter No Health Public Health Monitoring
1 NCCAM Clinical Digest e-Newsletter Survey Yes Yes Fillable Fileable Form and instruction NCCAM Clinical Digest e-Newsletter screenshots of survey (3).doc
Individuals or Households 570 48 0

Omnibus Survey of General Satisfaction with NIH Communication Issues No Health Health Care Services
1 Omnibus Survey Yes Yes Fillable Fileable Form and instruction App_B_Omnibus_Survey_Rand_Screenshots.docx
Individuals or Households 2000 67 0

Advocacy Organization Interviews No Health Health Care Services
1 Advocate Interview Guide No No Paper Only Form and instruction Appendix A_Advocate Interview Guide.docx
Individuals or Households 18 9 0

Grants Process Satisfaction Survey No Health Health Care Services
1 Researcher Survey Yes Yes Fillable Fileable Form and instruction App B_Researcher Survey Screens.pdf 2 Researcher Survey Text Version Yes Yes Fillable Fileable Form and instruction App A_Researcher Survey Text Version.pdf
Individuals or Households 1000 83 0

ClinicalTrials.gov Results Database Train-the-Trainer Workshop Feedback Survey No Health Health Care Services
1 Train-the-Trainer Workshop Feedback Survey Yes Yes Fillable Fileable Form and instruction NLM Train the Trainer Survey Instrument[1].pdf
Private Sector 90 18 0

Traveling Exhibition Host Survey No Health Health Care Services
1 Traveling Exhibition Host Survey Yes Yes Printable Only Form and instruction NLM HMD Traveling Exhibition Host Survey instrument and FU Phone Call.docx
Individuals or Households 250 125 0

NLM Emergency Access Initiative Satisfaction Survey No Health Health Care Services
1 EAI Satisfaction Survey Yes Yes Fillable Fileable Form and instruction NLM EAI Fast Track Survey Instrument (Survey Monkey screenshots).pdf
Individuals or Households 500 17 0

NIAMS KAI's Client Survey No Health Health Care Services
1 Client Survey Yes Yes Fillable Fileable Form and instruction NIAMS Survey 2013 Printscreens.docx
Individuals or Households 29 5 0

NCI Patient Education Publications Survey No Health Health Care Services
1 NCI Patient Education Publications Survey Yes Yes Fillable Fileable Form and instruction AttachB Survey Screenshots 8-20-13_REV.pdf
Individuals or Households 200 33 0

User Survey for finding aids software/application and website No Health Health Care Services
1 Finding Aid Survey Yes Yes Fillable Fileable Form and instruction Finding Aid Survey (Revised 10-18-13).pdf
Private Sector 100 17 0

NHLBI Health Information Center (HIC) Customer Satisfaction Survey Plan No Health Health Care Services
1 Online Survey Yes Yes Fillable Fileable Form and instruction NHLBI Customer Satisfaction Survey Online Form.docx 1 Telephone Survey No No Paper Only Form and instruction HIC IVR Customer Satisfaction Survey for Quality Test.docx
Individuals or Households 950 45 0

Qualitative Research to Explore Young People's Choices to Pursue a Career as a Physician Scientist No Health Consumer Health and Safety
3 Young Faculty Moderator Guide Yes Yes Fillable Fileable Form and instruction Young Faculty Moderator Guide FINAL 12-02-13 FOCUS GROUPS.doc 1 Recruitment and Screening Form Yes Yes Fillable Fileable Form and instruction Recruitment Messages and Screening Tool for Student Focus Groups 12-03-13.doc 2 Research Student Modertaor Guide Yes Yes Fillable Printable Form and instruction Research Student Moderator Guide FINAL 12-02-13 - FOCUS GROUPS].doc
Individuals or Households 330 183 0

Qualitative Research to Explore Young People's Choices to Pursue a Career as a Physician Scientist (Interviews) No Health Consumer Health and Safety
1 Research Dean Interview Guide Yes Yes Printable Only Form and instruction Research Dean Interview Guide12-10-13 FINAL.doc 2 Woman Physician-Scientist -Interview Guide Yes Yes Printable Only Form and instruction Woman Physician-Scientist Interview Guide 12-10-13 FINAL.doc
Individuals or Households 45 23 0

2012-01-12-05:00

0925-0649 201307-0925-004 0925
             
        "The Healthy Communities Study: How Communities Shape Childrens Health (NHLBI)"
             
          
        
The following submission provides information on Wave 2 of the National Heart, Lung, and Blood Institute's (NHLBI) planned "Healthy Communities Study (HCS): How Communities Shape Children's Health." An Information Collection Request (ICR) package was previously submitted to the Office of Management and Budget (OMB) and approval obtained for the first three years of planned data collection activities for the HCS, including Wave 1 of the study (OMB Notice of Approval 0925-0649 expiration date 1/31/2015). Four Communities were part of Wave 1 and the data was collected over the summer of 2012; Wave 2 consists of 264 new communities. Due to changes to the study protocol that resulted from the Wave 1 experience, a new ICR package is being submitted for Wave 2 of the study. The information is organized to respond directly to the 18 itemized subsections of Section A (Justification) of the Supporting Statement for Paperwork Reduction Act Submissions. A general description of the scope of work for the study is included below, as well as specific items in the Supporting Statement for Paperwork Reduction Act Submissions. Please refer to Attachment 1 for a list of study glossary of terms. 2016-08-31-04:00 Active Saleda Perryman No No No 69010 29505 0

Parents (screening) No Health Health Care Services
1 Family Screener No No Paper Only Form and instruction FINAL_HCS_SSA_ATTACH 5_FAMILY SCREENING_Jan 2013.docx
Individuals or Households 39600 6600 0

Parents/Caregivers No Health Health Care Services
2 Family Household Visit Protocol Overview No No Paper Only Form and instruction FINAL_HCS_SSA_ATTACH 6_PARENT PROTOCOL_Jan 2013 v2.docx
Individuals or Households 7128 11120 0

Second Parents No Health Health Care Services
3 Family Household Visit Protocol Overview No No Paper Only Form and instruction FINAL_HCS_SSA_ATTACH 7_2ND PARENT PROTOCOL_Jan 2013 v2.docx
Individuals or Households 3564 416 0

Parents/Caregivers (who refused) No Health Health Care Services
4 Parents/Caregivers (who refuse) No No Paper Only Form and instruction FINAL_HCS_SSA_ATTACH 8_PARENT REFUSAL PROTOCOL_Jan 2013.docx
Individuals or Households 880 147 0

Children No Health Health Care Services
5 Family Household Visit Protocol Overiview for Child No No Paper Only Form and instruction FINAL_HCS_SSA_ATTACH 9_CHILD PROTOCOL_Jan 2013 v2.docx
Individuals or Households 7128 7413 0

Key Informats (screening) No Health Health Care Services
6 KI Screening Protocol Overview No No Paper Only Form and instruction FINAL_HCS_SSA_ATTACH 12_KI SCREENING_Jan 2013.docx
Individuals or Households 3520 293 0

Key Informants No Health Health Care Services
7 Key Informant Interview Protocol No No Paper Only Form and instruction FINAL_HCS_SSA_ATTACH 13_KI PROTOCOL_Jan 2013.docx
Individuals or Households 1056 2376 0

Food Service Personnel No Health Health Care Services
9 School Lunch Observations No No Paper Only Form and instruction FINAL_HCS_SSA_ATTACH 15_SCHOOL LUNCH OBS_Jan 2013.docx
Individuals or Households 352 29 0

Physical Education Instructiors No Health Health Care Services
10 PARA No No Paper Only Form and instruction FINAL_HCS_SSA_ATTACH 16_SCHOOL PARA_Jan 2013.docx
Individuals or Households 352 88 0

State Health Department Employees No Health Health Care Services
1 Health Department Script Yes Yes Fillable Fileable Form and instruction HCS_SSA_ATTACH 18_HEALTH DEPT SCRIPT_SEPTEMBER 2011 FINAL for OMB.docx
Individuals or Households 0 0 0

Physicians/Medical Secretaries No Health Health Care Services
8 Medical Record Retrieval No No Paper Only Form and instruction FINAL_HCS_SSA_ATTACH 20_RECORD SELECT-RETRIEVAL PROTOCOL_Jan 2013.docx
Individuals or Households 4990 832 0

District Food Service Administrator/Manager No Health Health Care Services
11 School Food Environment Instrument No No Paper Only Form and instruction FINAL_HCS_SSA_ATTACH 18_SCHOOL FOOD ENV SURVEY_Jan 2013.docx
Individuals or Households 88 44 0

School Liaisons No Health Health Care Services
13 School Physical Activity and Nutrition Policies and No No Paper Only Form and instruction FINAL_HCS_SSA_ATTACH 19_SCHOOL POLICIES SURVEY_Jan 2013.docx
Individuals or Households 352 147 0

2013-08-06-04:00

0925-0650 201201-0925-004 0925
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIMH)"
             
          
        
This collection of information is necessary to enable the Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Mental Health (NIMH) following to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the Agency's programs. 2015-01-31-05:00 Active Saleda Perryman No No No 85350 13224 0

Customer Satisfaction Surevys - E-mail Services and On-line Ordering No Health Public Health Monitoring
2 On-line Ordering Survey Yes Yes Fillable Printable Form NIMH Publication Ordering Service Customer Satisfaction Survey script 7 19 2012 Final.doc 1 E-mail Services Yes Yes Fillable Printable Form NIMH E-mail Service Customer Satisfaction survey script 7 19 2012 Final.doc
Individuals or Households 1700 142 0

2012-01-30-05:00

0925-0651 201111-0925-007 0925
             
        "Genetic Testing Registry (OD)"
             
          
        
In 2010, NIH announced its plan to develop the Genetic Testing Registry (GTR), a centralized, online resource that will provide information about the availability and scientific basis of genetic tests. With an increasing number of genetic tests available, NIH recognized the importance of making information about these tests easily accessible to health care providers, researchers, patients, consumers, payers, and others. The overarching goal of the GTR is to advance the public health and research in the genetic basis of health and disease. As such, the Registry will have several key functions, including (1) encouraging providers of genetic tests to enhance transparency by publicly sharing information about the availability and utility of their tests; (2) providing an information resource for the public, including health care providers, patients, and researchers, to locate laboratories that offer particular tests; and (3) facilitating genetic and genomic data-sharing for research and new scientific discoveries. The GTR will be created, designed, and maintained by the NIH National Center for Biotechnology Information (NCBI) with input from the stakeholder community and oversight by an NIH steering group. Respondents to the GTR are expected to include clinical laboratories, test manufacturers, researchers, and entities that report and interpret tests performed elsewhere. The GTR is not limited to U.S. respondents; it will also include submissions from outside the United States. Information will be collected and managed using an online submission system. 2015-02-28-05:00 Active Seleda Perryman 202 690-5521 No No No 9240 27720 0

Laboratory Personnel No Health Health Care Services
1 Registry Yes Yes Fillable Fileable Form and instruction Attachment2_GTR Screenshots[1].pdf
Private Sector 9240 27720 0

2012-02-29-05:00

0925-0652 201202-0925-002 0925
             
        "End-of-Life and Palliative Care Science Needs Assessment: Funding Source Questionnaire (NINR)"
             
          
        
Despite the multiple recommendations from the Institute of Medicine calling for investment in end-of-life and palliative care (EOL PC) research, there is a limited understanding of who the stakeholders in EOL PC science are, the funding trends for EOL PC science (now and in the future), and the impact of past, current, and future partnerships between government, philanthropic organizations, academic research institutes, and/or others in building this important field of science. While no data were available, findings from one review indicate that directed funding streams for EOL PC research by federal and major philanthropic sources are not fully addressing the breadth and depth of EOL PC scientific issues encompassing the field, and research funding may be shrinking. The National Institute for Nursing Research (NINR) seeks to implement a needs assessment of EOL PC science funding trends and topics. This formative data will inform NINR, NIH Institutes and Centers, and other Federal and non-Federal Agencies about current EOL PC funding trends and priorities and create synergies for federal, private, and academic research networks to stimulate research capacity in this field. As part of the EOL PC research needs assessment, the Funding Source Questionnaire will identify funding organizations of EOL PC research studies published from 1997 through 2010, when a funding source was not cited or the funding source information was unclear in the research publication. This information will be used in the analysis of the published EOL PC research literature to determine which, if any, agencies or organizations funded the published research. This information will aid in understanding EOL PC research funding trends so that future funding of EOL PC research grants can be better coordinated by NIH, other Federal agencies, and non-government organizations and philanthropic groups. 2015-03-31-04:00 Active Seleda Perryman 202 690-5521 No No No 1840 147 0

Researchers No Health Health Care Services
1 Funding Source Questionnaire Yes Yes Fillable Fileable Form and instruction Attachment 1- FUNDING SOURCE QUESTIONNAIRE v5(rev 03-01-2012).docx
Individuals or Households 1840 147 0

2012-03-08-05:00

0925-0653 201202-0925-003 0925
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NINR)"
             
          
        
This collection of information is necessary to enable the Agency to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the Agency's programs. 2015-03-31-04:00 Active Saleda Perryman No No No 4425 3075 0

Focus Groups on proposed materials for a pediatric palliative care communications campaign No Health Health Care Services
2 Focus Group Moderator Guide Yes Yes Fillable Fileable Form and instruction Appendix C_Focus Group Moderator Guide.doc 1 Focus Group Screener and Consent Yes Yes Fillable Fileable Form and instruction Appendix B_Screenshots Focus Group Screener and consent.pdf 3 Focus Group Screenshots Yes Yes Fillable Fileable Form and instruction Appendix D_Screenshots Focus Group.pdf
Private Sector 69 44 0

2012-03-12-04:00

0925-0654 201209-0925-002 0925
             
        "A multi-center international hospital-based case-control study of  lymphoma in Asia (AsiaLymph) (NCI)"
             
          
        
This is a request for an extension of the "AsiaLymph Study" which includes non-substantive changes to the questionnaire but no changes to burden requested, scope or methodology of the study. The project focuses on collecting critically needed information to understand and reduce the cancer burden from lymphoid malignancies in the Asian population, the incidence of which has risen in recent decades. Specifically, environmental exposures to industrial emissions, genetic susceptibility, viral exposures, early life exposures, ultraviolet (UV) radiation exposures, and other risk factors for lymphoma overall and specifically for populations in Asia will continue to be examined. 2015-10-31-04:00 Active Saleda Perryman No No No 8606 5302 0

Patient Screener, Core & Occupational Exposure Questionnaires_AsiaLymph (Attachments 3, 4 & 5) No Health Consumer Health and Safety
3F Screener and Core Questionnaire-Taiwan (Chinese) Yes Yes Fillable Fileable Form and instruction Attach 3F -Screen&CoreQx_Taiwan_Chinese.pdf 3E Screener and Core Questionnaire-Taiwan (English) Yes Yes Fillable Fileable Form and instruction Attach 3E -Screen&CoreQx_Taiwan_English.pdf 3D Screener and Core Questionnaire-Chengdu (Chinese) Yes Yes Fillable Fileable Form and instruction Attach 3D -Screen&CoreQx_Chengdu_Chinese.pdf 3C Screener and Core Questionnaire-Chengdu (English) Yes Yes Fillable Fileable Form and instruction Attach 3C -Screen&CoreQx_Chengdu_English.pdf 3B Screener and Core Questionnaire-Hong Kong (Chinese) Yes Yes Fillable Fileable Form and instruction Attach 3B -Screen&CoreQx_HongKong_Chinese.pdf 3H Screener and Core Questionnaire-Tianjin (Chinese) Yes Yes Fillable Fileable Form and instruction Attach 3H -Screen&CoreQx_Tianjin_Chinese.pdf 3A Screener and Core Questionnaire-Hong Kong (English) Yes Yes Fillable Fileable Form and instruction Attach 3A -Screen&CoreQx_HongKong_English.pdf 4 Occupational Job Exposure Modules - examples Yes Yes Fillable Fileable Form and instruction Attach 4 - Occupational_Job_Modules-_examples revised 2-26-12.docx 5 Occupational Job Exposure Modules - complete set Yes Yes Fillable Fileable Form and instruction Attach 5 - Occupational_Job_Modules_-_complete_set revised 2-26-12.docx 3G Screener and Core Questionnaire-Tianjin (English) Yes Yes Fillable Fileable Form and instruction Attach 3G -Screen&CoreQx_Tianjin_English.pdf
Individuals or Households 5300 4108 0

Pathologist Administrative Form (Attachment 8) No Health Consumer Health and Safety
8 Administrative form for the Pathologist Yes Yes Fillable Fileable Form and instruction Attach 8 -_Admin_form_pathologist_REV_07-02-12.pdf
Individuals or Households 1102 92 0

Interviewer Administrative Forms (Attachment 9) No Health Consumer Health and Safety
9 Administrative forms for the Interviewer Yes Yes Fillable Fileable Form and instruction Attach 9 -_Admin_forms_interviewers_REV_07_02_12.pdf
Individuals or Households 2204 1102 0

2012-10-19-04:00

0925-0655 201202-0925-001 0925
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIDA)"
             
          
        
This collection of information is necessary to enable the Agency to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the Agency's programs. 2015-03-31-04:00 Active Mikia Currie 3014350941 No No No 2220 1548 0

Neuroscience Information Framework Search Survey No Health Health Care Services
1 NIF Survey Yes Yes Fillable Fileable Form and instruction NIDA- Fast Track (OMB Cntrl # 0925-0655) Screenshot Neuroscience Information Framework Search Survey 01022013.pdf
Individuals or Households 100 17 0

NIDA for Teens Web Site on Usefulness and Knowledge to be Learned No Health Health Care Services
No No Paper Only Instruction NIDA Fast Track (OMB Cntrl # 0925-0655)- Instructions for Teachers.docx 1 Student Survey Screenshots Yes Yes Fillable Fileable Form NIDA Fast Track (OMB Cntrl #0925-0655) - Student Survey Screenshot.pdf 2 Teacher Survey Screenshots Yes Yes Fillable Fileable Form NIDA Fast Track (OMB Cntrl #0925-0655) -Teacher Survey Screenshot.pdf No No Paper Only Instruction NIDA Fast Track (OMB Cntrl #0925-0655) - Instructions for Students.docx
Individuals or Households 420 190 0

2012-03-19-04:00

0925-0656 201112-0925-002 0925
             
        "Cancer Risk in U.S. Radiologic Technologists:  Fourth Survey (NCI)"
             
          
        
The Radiation Epidemiology Branch and the University of Minnesota have followed a nationwide cohort of 146,022 U.S. radiologic technologists (USRT) since 1982 to assess cancer and other disease risks associated with long-term repeated low doses of ionizing radiation. The USRT Study is the largest cohort of medical radiation workers studied to date and the only one with substantial numbers of women, extensive covariate data, incident and fatal cancer and other outcomes, estimates of individual historical occupational radiation doses, personal medical radiation doses, and personal and residential solar ultraviolet radiation (UVR) doses. Three OMB-approved questionnaires have been administered during 1983-2005 along with the collection of biospecimens for breast and thyroid cancer cases and comparison subjects. Study objectives for the next five years are to: (a) assess risks of cancer and other diseases from long-term low-dose occupational and personal medical radiation exposures; (b) assess risks of cancer and other diseases from occupational exposure to emerging and evolving radiologic modalities (i.e. nuclear medicine, interventional radiography); (c) assess risks of skin and other cancers from solar ultraviolet radiation exposures; (d) replicate main genotype effects for breast cancer reported from genome-wide association studies (GWAS) and evaluate genetic determinants for thyroid and skin cancers; and (e) evaluate gene-radiation and ionizing-ultraviolet radiation interactions for breast, thyroid, skin and other cancers. A fourth questionnaire survey will collect information on work history with nuclear medicine and interventional radiography procedures to improve dosimetry, new cancer and other disease outcomes, and other disease risk factors to further clarify the role of radiation and other factors in risks of cancer and other disease incidence and mortality. 2015-04-30-04:00 Active Saleda Perryman No No No 37053 14746 0

Fourth Survey CORE Module (Attachment 1A) No Health Consumer Health and Safety
1A CORE module Yes No Printable Only Form and instruction Attachment 1A-USRT_4Survey_091411.pdf
Individuals or Households 21700 10850 0

Fourth Survey NM Module (Attachment 1B) No Health Consumer Health and Safety
1B Nuclear Medicine Module Yes No Printable Only Form and instruction Attachment 1B-NuclearMed_091411.pdf
Individuals or Households 7000 2333 0

Fourth Survey FG Module (Attachment 1C) No Health Consumer Health and Safety
1C Fluoroscopically-guided (FG) Interventional Module Yes No Printable Only Form and instruction Attachment 1C-Fluoroscopy_091411.pdf
Individuals or Households 6300 1050 0

Medical Validation (Attachment 3) No Health Consumer Health and Safety Individuals or Households 2053 513 0

2012-04-23-04:00

0925-0657 201203-0925-001 0925
             
        "NIEHS DERT Extramural Grantee Data Collection"
             
          
        
The National Institute of Environmental Health Sciences, Division of Extramural Research and Training (DERT), is requesting a generic clearance to conduct assessment of selected science portfolios. A framework for examining research impact has been developed. DERT proposes to extend our ability to analyze our portfolios through primary data collection. The purpose of the proposed primary data collection is to obtain information from grantees regarding the impact of their funded research in the short-, intermediate- and long-term. This will be done through a survey of grantees that includes questions about the impact of funding on career development, the field of research, commercial product development, clinical practice, business and industry practices, and long-term human and environmental health, as well as satisfaction program support. Each researcher will receive an invitation to complete a 15-minute, close-ended, survey on the web. A paper option will be provided. 2015-06-30-04:00 Active Saleda Perryman No No No 600 300 0 2012-06-11-04:00

0925-0658 201202-0925-004 0925
             
        "Application for Collaboration with the NIH Center for Translational Therapeutics (NCTT)"
             
          
        
The mission of the National Institutes of Health Center for Translational Therapeutics (NCTT) is to translate fundamental research into patient treatments by establishing creative partnerships and developing innovative approaches to advance the science of drug discovery. The NCTT (1) is an intramural organization, and (2) solicits collaborators in the NIH-novel area of preclinical drug development. NCTT will use the data collected to determine the suitability of the Principal Investigators/Research Scientists(applicants)for collaboration with NCTT staff and programs. 2015-06-30-04:00 Active Saleda Perryman No No No 510 510 0

Online Collaborator Solicitation No Health Consumer Health and Safety
Attachment 1 Online Collaborator Solicitation Yes No Fillable Fileable Form and instruction Attachment 1 - Online Collaborator Solicitation - Final.pdf
Individuals or Households 170 170 0

NCTT Project Information Template No Health Consumer Health and Safety
2 NCTT Project Information Template Yes Yes Fillable Fileable Form and instruction Attachment 2 - NCTT Project Information Template.pdf
Individuals or Households 170 170 0

Solicitation Instructions (TRND) No Health Consumer Health and Safety
3 Solicitation Instructions (TRND). Yes Yes Fillable Fileable Form and instruction Attachment 3 - Solicitation Instructions (TRND).pdf
Individuals or Households 100 100 0

Solicitation Instructions (BrIDGs) No Health Consumer Health and Safety
4 BrIDGs Program Online Collaborator Solicitation Yes Yes Fillable Fileable Form and instruction BrIDGs Program Online Collaborator Solicitation (2).pdf
Individuals or Households 70 70 0

2012-06-11-04:00

0925-0659 201112-0925-003 0925
             
        "The SSA-NIH Collaboration to Improve the Disability Determination Process: Validation of IRT-CAT Tools (CC)"
             
          
        
This research includes the feasibility of comprehensively examining function through development of Computer Adaptive Tests (CAT) that could improve the SSA disability determination process. To validate the CAT assessments that have been developed, the contractor will administer both the BU-HDR CAT and established legacy instruments in a small sample of adults who report their current employment status as "permanently disabled". 2015-06-30-04:00 Active Mikia Currie 3014350941 No No No 1000 500 0

Patients No Health Immunization Management
1 Demographics Yes Yes Fillable Fileable Form and instruction Attachment 1_Socio demographic Information Collected.docx 2 Screener Yes Yes Fillable Fileable Form and instruction Attachment 2_screener questions.docx 3 Item Banks No No Fillable Fileable Form and instruction OMB Copy of Item Banks.pdf 4 PROMIS Yes Yes Fillable Fileable Form and instruction PROMIS item bank.pdf
Individuals or Households 1000 500 0

2012-06-12-04:00

0925-0660 201204-0925-001 0925
             
        "Solar Cell: A Mobile UV Manager for Smart Phones (NCI)"
             
          
        
The small business conducting the research hopes to begin information collection at the end of May when ultraviolet radiation (UV) in sunlight is at its highest. The overall primary objective of this project is to produce, deploy, and evaluate the effectiveness of a state-of-the-art software application for smart phones (i.e., mobile application), Solar Cell. This software application supports decision-making related to sun protection and exposure by Americans to reduce the risk of developing skin cancer attributable to chronic and severe UV exposure and developing other cancers attributable to vitamin D deficiency. 2014-02-28-05:00 Active Saleda Perryman No No No 2365 308 0

Appendix H: Telephone Screener for Solar Cell No Health Consumer Health and Safety
1 Screener No No Printable Only Form and instruction Appen_G_TelephoneScreener_162012.docx
Individuals or Households 1875 63 0

Appendix A: Pretest Survey No Health Consumer Health and Safety
1 Solar Cell Pretest Yes Yes Fillable Fileable Form and instruction Appen_A_Solar Cell Pretest_REV_05312012.docx
Individuals or Households 245 82 0

Appendix B: Post-Test Survey No Health Consumer Health and Safety
2 Solar Cell Posttest Yes Yes Fillable Fileable Form and instruction Appen_B_Solar Cell Posttest_04092012.docx
Individuals or Households 245 163 0

2012-06-13-04:00

0925-0661 201206-0925-004 0925
             
        "Neuropsychosocial Measures Formative Research Methodology Studies for the National Childrens Study (NICHD)"
             
          
        
This information collection involves the collection of neurodevelopmental and psychosocial measures gathered via physical examinations, designed experimental tasks, surveys, focus groups, and/or cognitive interviews to assess physical, emotional, and neurological development, psychosocial growth and adaptation, and behavioral changes in both children and adults. This Neuropsychosocial Generic Clearance will allow the NCS to develop best-practice protocols and by answering several questions surrounding child development. 2015-06-30-04:00 Active Saleda Perryman No No No 11500 19500 0

LOI2 QUEX 8 Development and Validation of an Autism Case Confirmation Approach for Use in the National Children's Study No General Science and Innovation Scientific and Technological Research and Innovation
1.4 LO12 QUEX-8 Autism Diagnostic Screener (ADI-S) Yes Yes Printable Only Form and instruction Attach_4_LOI2-QUEX-8_-_Autism_Diagnostic_Interview-Screener_(ADI-S).docx 1.2 LOI2 QUEX-8 Exemplar Telephone Script Yes Yes Paper Only Form and instruction Attach 2 LOI2-QUEX-8 Exemplar Telephone Script.pdf 1.6 LOI2 QUEX-8 Screening Tool for Autism in Toddlers (STAT-NCS) Yes Yes Paper Only Form and instruction Attach 6 LOI2-QUEX-8 - Screening Tool for Autism in Toddlers (STAT-NCS).docx 1.5 LOI2 QUEX-8 Parent Video-Guided Self Report (VGPR) Yes Yes Paper Only Form and instruction Attach 5 LOI2-QUEX-8 - Parent Video-Guided Self Report (VGPR).pdf
Individuals or Households 1425 1275 0

LOI2-QUEX-5 Bayley-3 Short Form for the National Children's Study AND LOI3-MHLTH-09 A Methodological Study to Assess Mental Disorders for NCS Birth Parents No General Science and Innovation Scientific and Technological Research and Innovation
1.5 Survey Yes Yes Paper Only Form and instruction B.5 LOI3-MHLTH-09 Revised CIDI.docx 1.2 Survey - Placeholder for Copyrighted Item Yes Yes Paper Only Form and instruction A.7 LOI2-QUEX-5 Bayley Instrument Cover Sheet.docx 1.3 Survey Yes Yes Paper Only Form and instruction B.3 LOI3-MHLTH-09 Recruitment Script.docx 1.1 Survey Yes Yes Paper Only Form and instruction A.1 LOI2-QUEX-5 Exemplar Telephone Screener.docx 1.4 Survey Yes Yes Paper Only Form and instruction B.4 LOI3-MHLTH-09 Parental Mental Health Screen.docx
Individuals or Households 5050 1589 0

2012-06-26-04:00

0925-0662 201205-0925-005 0925
             
        "Web-Based Assessment of the Clinical Studies Support Center (CSSC)"
             
          
        
A Web-based questionnaire will be administered to Chairs and members of monitoring boards to learn their opinions about specific CSSC activities and their satisfaction with the performance of CSSC staff. 2015-06-30-04:00 Active Mikia Currie 3014350941 No No No 90 30 0

Board Chairs No Health Health Care Services
3 Chair Questionaire Yes Yes Printable Only Form and instruction Attachment #3 CSSC Chair Questionnaire.docx 5a Assessment Screens Chairs Yes Yes Fillable Fileable Form and instruction Attachment #5a-Draft CSSC Assessment Screens Final CHAIRS.docx
Individuals or Households 11 4 0

Board Members No Health Health Care Services
4 Member Questionaire Yes Yes Paper Only Form and instruction Attachment #4 CSSC Member Questionnaire.docx 5b Assessment Screens Members Yes Yes Fillable Fileable Form and instruction Attachment #5b- Draft CSSC Assessment Screens-Members.docx
Individuals or Households 79 26 0

2012-06-27-04:00

0925-0663 201209-0925-001 0925
             
        "Generic Clearance for Cognitive Testing of Instrumentation and Materials for the PATH Study (NIDA)"
             
          
        
This request is for cognitive interviewing and testing of instrumentation and materials associated with the NIH/FDA study called PATH. PATH is designed to establish a population-based framework to monitor the behavioral and health impacts of smoking prevention programs. This generic clearance is designed to inform the development of the instrumentation for the PATH study's baseline and follow-up waves of data and biospecimens collection. Cognitive testing will help to ensure that their design and content are valid and meet the PATH study's objectives. Additionally, results from cognitive testing will inform the feasibility (scientific robustness), acceptability (burden to participants and study logistics) and cost of the information collection to help minimize its estimated cost and public burden. The study will use descriptive methods in analysis. 2015-11-30-05:00 Active Mikia Currie 3014350941 No No No 12000 6000 0 2012-11-27-05:00

0925-0664 201312-0925-006 0925
             
        "Population Assessment of Tobacco and Health (PATH) Study (NIDA)"
             
          
        
Enactment of the FSPTCA granted FDA regulatory authority over tobacco products to protect public health and reduce tobacco use among Americans, particularly young people. The NIH, through NIDA, is partnering with FDA's newly established Center for Tobacco Products (CTP) in a large-scale collaboration to conduct the PATH study. This national longitudinal study of tobacco use and health will provide epidemiological, population-based data about attitudes and perceptions related to the use of different existing and emerging tobacco products; patterns and trends in use of existing and emerging tobacco products; knowledge of the contents of tobacco products and of the consequences of their use; and on near- and longer-term health outcomes associated with tobacco product use. These data will advance the scientific knowledge base on tobacco use behaviors and health; and serve to establish a regulatory science framework for FDA's development, implementation, and evaluation of effective product regulations to reduce tobacco-related diseases, disabilities, and deaths in the U.S. population. The PATH study also fills a data gap with its longitudinal cohort design. It is the only national longitudinal study of tobacco use. As such, this study provides a unique opportunity to monitor and assess changes over time in patterns of use of tobacco products among study respondents. The study will collect national longitudinal survey data from a cohort of approximately 59,587 current, former, and never tobacco product users ages 12 years and older in the U.S. Biospecimens will also be collected from adult respondents to assess objective measures of exposure and prospectively monitor indicators of tobacco use-related harm. 2015-11-30-05:00 Active Saleda Perryman No No No 560451 136889 0

PATH/Baseline- Adults Household Screener No Health Immunization Management
1 Household Screener Yes Yes Fillable Fileable Form and instruction 3a - English. PATH Wave 1 Household Screener 7.5 2013-06-10.pdf
Individuals or Households 104725 24436 0

PATH/Baseline - Adults Individual Screener No Health Immunization Management
1 Individual Screener Yes Yes Fillable Fileable Form and instruction 3b - English. PATH Wave 1 Individual Screener 7.5 2013-06-10.pdf
Individuals or Households 59500 5950 0

PATHBaseline- Adult Extended Interview No Health Immunization Management
1 Extended Interview Yes Yes Fillable Fileable Form and instruction 3c - English. PATH Wave 1 Adult Extended Interview 7.5 2013-06-10.pdf
Individuals or Households 42730 38457 0

PATH/Baseline-Adults-Biospecimen: Urine No Health Immunization Management
1 Urine Collection Yes Yes Fillable Fileable Form and instruction 3d c - English Biospecimen collection forms - Urine 050813.pdf
Individuals or Households 42730 7122 0

PATH/Baseline- Adults -Tobacco Use Form No Health Immunization Management
1 Tobacco Use Form Yes Yes Fillable Fileable Form and instruction 3e - English. PATH Wave 1 Tobacco Use Form 2013-06-10.pdf
Individuals or Households 42730 2849 0

PATH/Baseline- Adults-Followup/Tracking Participant Information Form No Health Immunization Management
1 Revised Adult Tracking Information Form Yes Yes Fillable Fileable Form and instruction FRT2 Adult Participant Information Form REVISED 121313.doc 1 Follow-up/Tracking Participant Information Form Yes Yes Fillable Fileable Form and instruction 3f - English. Followup Tracking participant Information Form 050813.pdf
Individuals or Households 85460 11395 0

PATH/Baseline-Youth Extended Interview No Health Immunization Management
1 Youth Extended Interview Yes Yes Fillable Fileable Form and instruction 3g - English. PATH Wave 1 Youth Extended Interview 7.5 2013-06-10.pdf
Individuals or Households 16186 8633 0

PATH/Baseline- Adult-Parent Interview No Health Immunization Management
1 Parent Interview Yes Yes Fillable Fileable Form and instruction 3h - English. PATH Wave 1 Parent Interview 7.5 2013-06-10.pdf
Individuals or Households 16186 3777 0

PATH/Baseline- Adults - Followup/Tracking Participant Information Form for Youth (completed by parents) No Health Immunization Management
1 Follow-up/Tracking Participant Information Form (completed by parents) Yes Yes Fillable Fileable Form and instruction 3i-English. Followup Tracking Participant Information Form - Youth 050813.pdf
Individuals or Households 32372 4316 0

PATH - Adults - Followup/Tracking Participant Information Form for Shadow Sample Youth(completed ny Parents)/Field Test No Health Immunization Management
1 Shadow Sample Yes Yes Fillable Fileable Form and instruction 3j-English. Followup Tracking Participant Information Form - Shadow Sample Youth 050813.pdf
Individuals or Households 32372 4316 0

PATH/Baseline-Adults-Biospecimen: Buccal No Health Immunization Management
1 Buccal Collection Yes Yes Fillable Fileable Form and instruction 3d b - English Biospecimen collection forms - Buccal Cell 050813.pdf
Individuals or Households 42730 12819 0

PATH/Baseline-Adults-Biospecimen: Blood No Health Immunization Management
1 Blood Collection Yes Yes Fillable Fileable Form and instruction 3d a - English Biospecimen collection forms - Blood 050813.pdf
Individuals or Households 42730 12819 0

2013-12-19-05:00

0925-0665 201308-0925-004 0925
             
        "Process Evaluation of  the NIH Director's Early Independence Award Program (EIA) "
             
          
        
This study is to document the program operations and activities of the NIH Early Investigator Awards Program, in order to improve the program and guide future strategic and management decisions. Information will be collected from appplicants, extramural reviewers, and awardees. Two online customer satisfaction surveys will be used to collect information from applicants, a paper survey will be used for information collection from reviewers, and a paper survey, phone interviews, and online surveys will be used for information collection from Program awardees. 2015-12-31-05:00 Active Saleda Perryman No No No 467 183 0

Process Evaluation of the EIA Program - Paper Survey Editorial Review Board No Health Public Health Monitoring
1 Paper Survey for Editorial Board Reviewers No No Paper Only Form and instruction Attachment A.2 - Paper Survey for Editorial Board Reviewers.doc
Individuals or Households 15 4 0

On-line Survey for Early Indepenedence Principal Investigators No Health Public Health Monitoring
Attachment 6 Screenshots of EIA PI Survey Yes Yes Fillable Printable Form and instruction Screenshots Online survey EIA Principal Investigators (versions AB).pdf
Individuals or Households 40 30 0

Customer Satisfaction Online Survey for Applicants: Principal Investigators (Ver A and B) No Health Public Health Monitoring
Attachment A3.3 Screenshots of Customer Satisfaction Online Survey: PI (Ver A&B) Yes Yes Fillable Fileable Form and instruction Attachment A.3.3 - Screenshots Customer Satisfaction Online Survey for Applicants (Principal Investigators).pdf
Individuals or Households 150 38 0

Phone Interview Questions for Early Indepenedence Prncipal Investigators No Health Public Health Monitoring
Attachment A5 Phone Interview Questions for EI-PI No No Paper Only Form and instruction Attachment A.5 - Phone Interview EIA Principal Investigators (Versions A & B).doc
Individuals or Households 24 24 0

Paper Survey for Early Independence Principal Investigator No Health Public Health Monitoring
Attachment A4 Paper Survey for EI-PI No No Paper Only Form and instruction Attachment A.4 - Paper Survey for Early Independence Principal Investigators.doc
Individuals or Households 24 12 0

Customer Satisfaction On-line Survey for Applicants: Officials of Host Institutions No Health Public Health Monitoring
Attachment A3.4 Screenshots for Customer Satisfaction On-line Host Survey Yes Yes Fillable Fileable Form and instruction Attachment A.3.4 - Screenshots Customer Satisfaction Online Survey for Applicants (Host Institutions).pdf
Individuals or Households 150 38 0

Phone Interview Questions for Point of Contact at Host Institutions No Health Public Health Monitoring
Attachment A7 Phone Interview Questions for Host Institutes No No Paper Only Form and instruction Attachment A.7 - Phone Interview Point of Contact Host Institution.doc
Individuals or Households 24 24 0

Online Survey for Point of Contact of Host Institutions No Health Public Health Monitoring
Attachment 8 Screenshots of the Online POC EIA Host Survey Yes Yes Fillable Printable Form Screenshots Online Survey Point of Contact Host Institution.pdf
Individuals or Households 40 13 0

2013-08-22-04:00

0925-0666 201211-0925-008 0925
             
        "National Institute of Nursing Research (NINR) Summer Genetics Institute Alumni Survey"
             
          
        
The National Institute of Nursing Research (NINR) Summer Genetics Institute (SGI) is a summer training program for nursing scientists. The SGI is designed to increase the genetics research capability among graduate students and faculty, and develop and expand the basis for clinical practice in genetics among clinicians. 2015-12-31-05:00 Active Mikia Currie 3014350941 No No No 150 75 0

Researchers No Health Health Care Services
1 Survey Yes Yes Fillable Fileable Form and instruction Attachment 2_SGI survey_screenshots_v2.docx
Individuals or Households 150 75 0

2012-12-20-05:00

0925-0667 201401-0925-001 0925
             
        "NDAR Data Access Request"
             
          
        
Several National Institutes of Health (NIH) data repositories require applicants to complete a data access request form, generally consisting of an abbreviated Standard Form 424 and a data use certification. The use of this previously OMB-approved information collection form was an expedient measure to jumpstart the use of these databases. The National Institute of Mental Health (NIMH) recently received OMB-approval for use of the National Database for Autism Research (NDAR) Data Use Certification Form (Title: NDAR Data Access Request; OMB Control Number: 0925-0667; Expiration Date: 01/31/2016). NIMH is interested in renaming this form the "NIMH Data Access Request and Use Certification (DUC) Form" and using it to meet the unique data access needs of all NIMH data repositories. There are currently three data repositories/sets positioned to use the NIMH DUC form: NDAR, the NIH Pediatric MRI Data Repository (PedsMRI), and the NIMH Clinical Research Datasets (NCRD). 2016-09-30-04:00 Active Mikia Currie 3014350941 No No No 1040 1646 0

Principal Investigators/Research Assistants No Health Health Care Services
No No Paper Only Instruction NDAR DUC terms_final (040513).docx No No Paper Only Instruction NCRD DUC terms_final (040513).doc 1 NDAR Data Access Request (DUC) Form No No Paper Only Form NDAR_Data_Access_Request_DUC_PRA[2].docx 1 NIMH DUC (NDAR and PedsMRI) No No Paper Only Form NIMH DUC_final (NDAR and PedsMRI) (revised).docx 1 NIMH DUC (NCRD) No No Paper Only Form NIMH DUC_final (NCRD)(revised).docx No No Paper Only Instruction PedsMRI DUC terms_final (040513).doc
Individuals or Households 40 63 0

NIMH DUC - GRDR No Health Public Health Monitoring
2 NIMH DUC - GRDR No No Paper Only Form and instruction GRDR DUC (110713).doc
Individuals or Households 1000 1583 0

2014-01-10-05:00

0925-0668 201212-0925-001 0925
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIAID)"
             
          
        
This collection of information is necessary to enable NIAID to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the Agency's programs. 2016-01-31-05:00 Active Mikia Currie 3014350941 No No No 28000 48300 0

User Feedback on NIAID's International Clinical Research Regulatory Matrix (ICRRM). No Health Health Care Services
1 User Feedback ICRRM). Yes Yes Fillable Fileable Form and instruction Screen Shots for ICRRM Data Collection Final.pdf
Private Sector 2000 100 0

User Feedback on NIAID's International Clinical Research Regulatory Matrix (ICRRM) No Health Health Care Services
1 User Feedback on NIAID's (ICRRM) Yes Yes Fillable Fileable Form and instruction Screen Shots for ICRRM Data Collection Final.pdf
Federal Government 4000 200 0

Grantees' Perceptions Regarding the NIAID DAIDS Phased Innovation Award (R21/R33) Funding Mechanism No Health Health Care Services
1 Grantee Survey Yes Yes Fillable Fileable Form and instruction PIA Grantee Survey Screenshots - Final (Revised).docx
Private Sector 76 19 0

Evaluation Form for the Bridging the Career Gap for Underrepresented Minority Scientists workshop No Health Health Care Services
1 BTCG Survey No No Paper Only Form and instruction Survey Instrument-BTCG 2013.doc
Private Sector 100 8 0

2013-01-14-05:00

0925-0670 201301-0925-003 0925
             
        "NIH Information Collection Forms to Support Genomic Data Sharing for Research Purposes"
             
          
        
The sharing of research data supports the mission of the National Institutes of Health (NIH) and is essential to facilitate the translation of research results into knowledge, products, practices, and procedures that improve human health. By enabling secondary research questions to be addressed, data sharing also maximizes research investments. In 2008, NIH implemented the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) to enable the full value of GWAS data to be realized. GWAS data are maintained in a central data repository, the database of Genotypes and Phenotypes (dbGaP), which is administered by the National Center for Biotechnology Information (NCBI), part of the National Library of Medicine at NIH. 2016-03-31-04:00 Active Saleda Perryman No No No 1366 1646 0

Study Registration and Data Submission No Health Consumer Health and Safety
2 Online Form for Study Registration Yes Yes Fillable Fileable Form and instruction Attachment_1_Updated_Screen_Shots_of_Online_Form_for_Study_Registration[1].pptx
Private Sector 100 63 0

Data Access Request (DAR) No Health Consumer Health and Safety
2 Screen Shots of Online Forms form Data Access Request, Renewal, and Close-out Yes No Fillable Fileable Form and instruction Attachment 3_Screen Shots of Online Forms for DAR Renewal Close-out updated time.pptx
Private Sector 1266 1583 0

2013-03-20-04:00

0925-0671 201301-0925-001 0925
             
        "Stress and Cortisol Measurement for the National Childrens Study (NICHD)"
             
          
        
With this submission, the NCS seeks OIRA clearance to perform a multi-center substudy, called the Stress and Cortisol Measurement Substudy, aimed at developing a validated questionnaire that will reflect specific physiological measures of stress. This substudy will develop a common, core protocol for determining the most reliable, acceptable, and cost-efficient approach for assessing maternal stress in the form of a brief questionnaire that correlates with more invasive and burdensome approaches to the measurement of biological and physiological measures of stress. Birth outcomes have been selected for this substudy because they represent priority outcomes for the NCS, and they will be available and can be collected within the study timeframe. Identification of a standardized, validated approach to evaluate exposure to psychosocial stress during pregnancy will facilitate the measurement of stress as a variable of interest in the NCS by providing an efficient, low-burden approach to stress measurement. 2016-03-31-04:00 Active Mikia Currie 3014350941 No No No 1399 3147 0

Clinic Visit 1 No General Science and Innovation Scientific and Technological Research and Innovation
1.4 Survey Yes Yes Paper Only Form and instruction Attach 7.Visit 1 Stress Questionnaire.docx 1.3 Attach 6. Demographic and Health Survey Yes Yes Paper Only Form Attach 6. Demographic and Health Survey.docx 1.5 Survey Yes Yes Paper Only Form and instruction Attach 10. SLES Checklist.pdf 1.2 Form Yes Yes Paper Only Form Attach 4. Participant Contact Information Sheet.docx 1.1 Survey Yes Yes Fillable Printable Form and instruction Attach 2. Screening Tool.docx
Individuals or Households 700 972 0

Ambulatory Assessment Period No General Science and Innovation Scientific and Technological Research and Innovation
Yes Yes Paper Only Instruction Attach 19. Saliva Collection Participants Manual.docx Yes Yes Paper Only Other Attach 21. Saliva Specimen Log.doc Yes Yes Paper Only Instruction Attach 22. Electronic Diary Coordinators Manual.doc Yes Yes Paper Only Instruction Attach 23. Actiheart Procedures Coordinators Manual.doc 2.1 Attach 8. Take Home Packet Yes Yes Paper Only Form and instruction Attach 8. Take Home Packet.docx
Individuals or Households 233 1068 0

Clinic Visit 2 No General Science and Innovation Scientific and Technological Research and Innovation
3.1 Survey Yes Yes Paper Only Form and instruction Attach 9. Visit 2 Stress Questionnaire.docx
Individuals or Households 233 408 0

Follow Up Studies No General Science and Innovation Scientific and Technological Research and Innovation Individuals or Households 233 699 0

2013-03-25-04:00

0925-0672 201303-0925-005 0925
             
        "Pediatric Palliative Care Campaign Pilot Survey (NINR)"
             
          
        
NINR developed a Pediatric Palliative Care Campaign to address the communications challenges faced by health care providers who recommend and provide palliative care to pediatric populations. NINR is launching this effort to increase the use of palliative care for children living with serious illness or life-limiting conditions. The pilot campaign survey is designed to collect feedback from health care providers who are involved in pediatric palliative care to ensure that the information and materials being disseminated as part of the pilot are effective, relevant, and useful to health care providers and to better understand current perceptions, challenges, and information needs when it comes to discussing pediatric palliative care. Information obtained through this assessment is needed by NINR to evaluate the pilot campaign materials and to deliver strategic and actionable guidance for refining the materials so that they can be used by a wider audience of health care providers. Respondents to this survey will be health care providers at two pilot site hospitals who work with children living with serious illness or life-limiting conditions. 2016-05-31-04:00 Active Saleda Perryman No No No 50 26 0

Physicians (Pediatric Palliative Care Campaign Pilot Survey) No Health Health Care Services
1 Pediatric Palliative Care Campaign Pilot Survey Yes Yes Fillable Fileable Form and instruction Attachment 2_Survey Screenshots.pdf
Individuals or Households 25 13 0

Nurses (Pediatric Palliative Care Campaign Pilot Survey) No Health Health Care Services
1 Pediatric Palliative Care Campaign Pilot Survey Yes Yes Fillable Fileable Form and instruction Attachment 2_Survey Screenshots.pdf
Individuals or Households 25 13 0

2013-05-13-04:00

0925-0673 201303-0925-002 0925
             
        "Child Health Disparities Substudy for the National Children's Study (NCS)- Phase 1"
             
          
        
Phase I of the Child Health Disparities Substudy will involve conducting cognitive tests for content validity. The testing will focus on measures of health disparities, specifically health literacy, discrimination, stress and education level in mothers of small children across diverse populations. 2015-05-31-04:00 Active Mikia Currie 3014350941 No No No 160 68 0

Cognitive Interview Screener No General Science and Innovation Scientific and Technological Research and Innovation
1.1 Survey Yes Yes Paper Only Form and instruction Attach 2. In-person Screening Script.docx 1.2 Survey Yes Yes Paper Only Form and instruction Attach 3. Telephone Screening Script.doc 1.3 Survey Yes Yes Paper Only Form and instruction Attach 5. Cognitive Interview Screener.docx
Individuals or Households 100 8 0

Cognitive Interview Guide No General Science and Innovation Scientific and Technological Research and Innovation
2.1 Survey Yes Yes Paper Only Form and instruction Attach 6. Cognitive Interview Guide.docx
Individuals or Households 60 60 0

2013-05-15-04:00

0925-0674 201305-0925-001 0925
             
        "CLINICAL MYTH-TERIES: A VIDEO GAME ABOUT CLINICAL STUDIES (NHLBI)"
             
          
        
This project plans to develop a serious (educational) video game called Paper Kingdom for adolescents (8-14 years) to build upon core messages of the No More Hand Me Downs: Clinical Studies in Children web site supported by NHLBI. This game It will provide storylines with expeditions or pursuits where the player must help their 'brother' in the game take his medication. Through playing the game, users will encounter several obstacles which they must overcome and through which they will learn about clinical research. To complete each level they will demonstrate that they have understood the myths or misconceptions presented. In the end, they will help their brother through all of his concerns. Specific Aims of the study will be to: o Aim 1: Expand and refine Paper Kingdom game modules (content and direction) based on participatory evaluation with Scientific Advisors to address the Learning Objectives (LO). o Aim 2: Extend and refine Paper Kingdom game functionalities (usability and interactivity) based on feedback from the participatory evaluation from the Scientific Advisory Board, and focus groups with adolescents. Three focus groups with 10 participants each (n=30) are planned. o Aim 3: Evaluate the effectiveness of the Paper Kingdom approach to improving adolescent engagement, awareness, and knowledge about clinical studies in a pre/post randomized trial. We plan to recruit 250 adolescents for the evaluation. o Aim 4: Complete the final version of Paper Kingdom to be released to schools, health clinics, individuals and other interested parties. 2016-05-31-04:00 Active Saleda Perryman No No No 840 424 0

Adolescents (Wave One) No Health Health Care Services
3 Qualitative Focus Group Discussion and Screener No No Paper Only Form and instruction Attachment 3 - Qualitative Focus Group Discussion Guide and screener.docx
Individuals or Households 30 45 0

Adolescents (Wave Two) No Health Health Care Services
5 Screenshots of the Pre Post Evaluation Yes Yes Fillable Fileable Form and instruction Attachment 8 - Screenshots of Pre Post Evaluations.docx 4 Screen Pre Post Evaluation No No Paper Only Form and instruction Attachment 5 - Screen pre post eval.docx
Individuals or Households 250 333 0

Guardian (Wave One and Two) No Health Health Care Services
1 Consent for participation in Research No No Paper Only Form and instruction Attachment 1 - Consent for Participation in Research- Guardian.docx
Individuals or Households 280 23 0

Adolescents (Wave One and Two) No Health Health Care Services
2 Assent for Participation in research Child No No Paper Only Form and instruction Attachment 2 - Assent for Participation in Research- Child.docx
Individuals or Households 280 23 0

2013-05-22-04:00

0925-0675 201303-0925-001 0925
             
        "Generic Clearance for Methodological Studies in the Population Assessment of Tobacco and Health (PATH) Study (NIDA)"
             
          
        
This is a new 3-year clearance request for methodological studies to support the Population Assessment of Tobacco and Health (PATH) Study. The methodological studies will use a variety of approaches and will be limited in size, scope, and duration to identify ways to improve how the PATH Study achieves its objectives in each aspect of its implementation, data collection procedures, and techniques for achieving and maintaining high response, retention, and follow up rates. 2016-05-31-04:00 Active Saleda Perryman No No No 20000 89250 0 2013-05-22-04:00

0925-0676 201304-0925-001 0925
             
        "The National Cancer Institute (NCI) SmokefreeTXT (Text Message) Program Evaluation"
             
          
        
This is a request for OMB to approve the new submission titled, "The National Cancer Institute (NCI) SmokefreeTXT Program Evaluation" for two years. The Office of the Assistant Secretary for Health (OASH) at the Department of Health and Human Services (DHHS) has requested the National Cancer Institute (NCI) Tobacco Control Research Branch (TCRB) develop and manage the SmokefreeTXT evaluation program, as part of a larger series of eHealth/mHealth tobacco cessation intervention programs. This evaluation has implications for international work that HHS deems crucial in designing and implementing similar programs in a variety of other countries. In addition, HHS is interested in increasing the visibility of the SmokefreeTXT domestic program as part of the resources it promotes via large scale promotional campaigns. This study seeks to assess the efficacy of a text message smoking cessation intervention designed for young adult smokers ages 18 to 29. Study plans include examining how exposure to the SmokefreeTXT intervention affects participants' success at quitting smoking. There will be 3-arms to the study; participants will be enrolled for a maximum of 8 weeks of treatment in the SmokefreeTXT program, with frequency and duration of the treatment varying by study arm. Self-reported cessation data will be collected using the text-messaging service and web-based surveys. Respondents will complete 5 web-based surveys for: pre-treatment/baseline, 1 week post quit, 6 weeks post quit, 12 week and 24 week post-treatment questionnaires. 2015-05-31-04:00 Active Saleda Perryman No No No 26258 4250 0

Screener Questionnaire (Attachment 9) No Health Consumer Health and Safety
1 Screener Yes Yes Fillable Fileable Form and instruction Attach9_SFTXT_Screener_12062012.doc
Individuals or Households 10620 885 0

Baseline Questionnaire (Attachment 10) No Health Consumer Health and Safety
2 Baseline Yes Yes Fillable Fileable Form and instruction Attach10_SFTXT_Baseline Survey_12062012.doc
Individuals or Households 2124 1062 0

1 Week Post Quit Date Questionnaire (Attachment 14) No Health Consumer Health and Safety
3 1 Week Post Quit Date Questionnaire Yes Yes Fillable Fileable Form and instruction Attach14_SFTXT_1WeekPostQuitQx_12062012.doc
Individuals or Households 1700 425 0

6 Weeks Post Quit Date Questionnaire (Attachment 15) No Health Consumer Health and Safety
4 6 Weeks Post Quit Date Questionnaire Yes Yes Fillable Fileable Form and instruction Attach15_SFTXT_6WeekEndTreatQx_12062012.doc
Individuals or Households 1360 680 0

12 Week Post Quit Date Questionnaire (Attachment 19) No Health Consumer Health and Safety
5 12 Week Post Quit Date Questionnaire Yes Yes Fillable Fileable Form and instruction Attach19_SFTXT_12WeekSurvey_12062012.docx
Individuals or Households 1088 272 0

24 Week Post Quit Date Questionnaire (Attachment 20) No Health Consumer Health and Safety
6 24 Week Post Quit Date Questionnaire Yes Yes Fillable Fileable Form and instruction Attach20_SFTXT_24WeekSurvey_12062012.docx
Individuals or Households 870 218 0

Exit Scripts and Survey for Ineligibles (Attachment 13) No Health Consumer Health and Safety
7 Exit Scripts and Survey for Ineligibles Yes Yes Fillable Fileable Form and instruction Attach13_SFTXT_IneligibleScriptSurvey_12062012.docx
Individuals or Households 8496 708 0

2013-05-30-04:00

0925-0677 201306-0925-009 0925
             
        "National Institute of Neurological Disorders and Stroke FITBIR Data Access Request"
             
          
        
The National Institutes of Health (NIH) created the Federal Interagency Traumatic Brain Injury Research Informatics System, an informatics system and central data repository, housed at the NIH Center for Information Technology, to support and accelerate research on traumatic brain injuries (TBI). FITBIR collects a wide range of data types, including phenotypic and clinical data as well as medical images, derived from individuals who participate in TBI research, regardless of the source of funding. FITBIR provides the infrastructure to store, search across, retrieve, analyze, and share these varied types of data. 2016-08-31-04:00 Active Saleda Perryman No No No 40 63 0

FITBIR Data Access Request No Health Health Care Services
1 FITBIR Data Access Request Yes Yes Fillable Fileable Form and instruction FITBIR data access V2 6-6-13.doc
Individuals or Households 40 63 0

2013-08-14-04:00

0925-0678 201307-0925-006 0925
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NINDS)"
             
          
        
This collection of information is necessary to enable the National Institute of Neurological Disorders and Stroke to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the Agency's programs. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. 2016-08-31-04:00 Active Saleda Perryman No No No 44100 17250 0 2013-08-29-04:00

0925-0679 201307-0925-005 0925
             
        "Financial Sustainability of Human Tissue Biobanking (NCI)"
             
          
        
The purpose of this web-based survey is to collect information regarding the challenges that human tissue biobanks encounter in achieving financially sustainable operations. The survey will collect a combination of structured, quantitative, and free-text descriptive data that characterize the type and maturity of respondent biobanks, their sources of funding, and their usage of funding in conducting operations. The survey will also collect information describing the difficulties in maintaining funding sources and establishing new ones. Finally, the survey will elicit descriptions of techniques used to overcome the difficulties. A combination of domestic and international biobanks will be asked to participate in the survey. 2014-09-30-04:00 Active Saleda Perryman No No No 548 822 0

Financial Sustainability of Human Tissue Biobanking Survey No Health Consumer Health and Safety
1 Biobanking Survey HTTP://biobank-survey.healthcit.com Yes Yes Fillable Fileable Form and instruction Attach1-Questionnaire Screen Shots-2.docx
Private Sector 548 822 0

2013-09-12-04:00

0925-0680 201307-0925-007 0925
             
        "National Cancer Institute (NCI) Cancer Nanotechnology Platform Partnership Scientific Progress Reports"
             
          
        
The National Institutes of Health grantees are required to submit interim and final progress reports and other post-award documents associated with the monitoring, oversight, and closeout of an award. This submission represents a request for OMB to approve new program specific progress report guidelines for Cancer Nanotechnology Platform Partnerships (CNPP) awarded by the National Cancer Institute (NCI). 2016-09-30-04:00 Active Seleda Perryman 202 690-5521 No No No 24 72 0

CANCER NANOTECHNOLOGY PLATFORM PARTNERSHIPS (CNPP; U01) Guidelines for CNPP Annual and Interim Reports No Health Consumer Health and Safety
1 Annual and Interim Report No No Printable Only Form and instruction Attachment 1_U01 Reports Guidelines-5-1-2013.docx
Individuals or Households 24 72 0

2013-09-12-04:00

0925-0681 201307-0925-003 0925
             
        "Feedback Survey for the Brain Disorders in the Developing World Program of the John E. Fogarty International Center (FIC)"
             
          
        
This study seeks to evaluate the Brain Disorders in the Developing World grant program administered by the John E. Fogarty International Center (FIC) at the National Institutes of Health (NIH). The goals of the program are to support and facilitate global health research conducted by U.S. and international investigators, build partnerships between health research organizations in the U.S. and abroad, and train the next generation of scientists to address global health needs. Between FY 2003 and 2012, a total of 132 awards were made under the Brain Disorders program, and the total investment by FIC and its partners at NIH has been approximately $75 million. The proposed data collection consists of a web-based census survey of awardees as well as telephone interviews with selected awardees and trainees. The results of the evaluation study will be used by FIC leadership in planning for the future of the Brain Disorders program and to determine whether this model could potentially be used in other contexts. 2016-09-30-04:00 Active Mikia Currie 3014350941 No No No 211 123 0

Awardee Survey (LMIC) No Health Health Care Services
1 LMIC Yes Yes Fillable Fileable Form and instruction Att5 LMIC Survey Instrument.docx No No Paper Only Instruction Att1 Informed Consent.docx
Individuals or Households 112 65 0

Awardee Survey (US and HIC) No Health Health Care Services
No No Paper Only Instruction Att1 Informed Consent.docx 2 US and HIC Yes Yes Fillable Fileable Form and instruction Att4 US Survey Instrument.docx
Individuals or Households 99 58 0

2013-09-23-04:00

0925-0682 201308-0925-002 0925
             
        "NIMH Office of Autism Research Coordination (OARC) Portfolio Analysis "
             
          
        
The purpose of the ASD portfolio analysis is to collect research funding data from U.S. and international ASD research funders, to assist the Interagency Autism Coordinating Committee (IACC) in fulfilling the requirements of the Combating Autism Act, and to inform the committee and interested stakeholders of the funding landscape and current directions for ASD research. Specifically, these analyses will examine the extent to which current funding and research topics align with the IACC Strategic Plan for ASD Research. The findings will help guide future funding priorities by outlining current gaps and opportunities in ASD research as well as serving to highlight annual activities and research progress. OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 419. 2016-09-30-04:00 Active Saleda Perryman No No No 1650 419 0

Autism Spectrum Disorder (ASD) Research Funders - U.S. Federal No General Government Central Fiscal Operations
1 Data Call Spreadsheet Yes Yes Fillable Printable Form Attachment 5_Data Call Spreadsheet (revised2).xlsx Yes Yes Fillable Printable Instruction Attachment 4_Data Call Guidance_revised.docx
Federal Government 936 234 0

Autism Spectrum Disorder (ASD) Research Funders - U.S. Private No General Government Central Fiscal Operations
1 Data Call Spreadsheet Yes Yes Fillable Printable Form Attachment 5_Data Call Spreadsheet (revised2).xlsx Yes Yes Fillable Printable Instruction Attachment 4_Data Call Guidance_revised.docx
Private Sector 648 162 0

Autism Spectrum Disorder (ASD) Research Funders - International Government No General Government Central Fiscal Operations
1 Data Call Spreadsheet Yes Yes Fillable Printable Form Attachment 5_Data Call Spreadsheet (revised2).xlsx Yes Yes Fillable Printable Instruction Attachment 4_Data Call Guidance_revised.docx
Federal Government 30 14 0

Autism Spectrum Disorder (ASD) Research Funders - International Private No General Government Central Fiscal Operations
1 Data Call Spreadsheet Yes Yes Fillable Printable Form Attachment 5_Data Call Spreadsheet (revised2).xlsx Yes Yes Fillable Printable Instruction Attachment 4_Data Call Guidance_revised.docx
Federal Government 36 9 0

2013-09-26-04:00

0925-0683 201309-0925-001 0925
             
        "Palliative Care: Conversations Matter Evaluation (NINR)"
             
          
        
This is the next step in NINR's Palliative Care: Conversation Matters campaign. NINR previously submitted an OMB clearance request for the pilot phase of this campaign. The campaign is now being officially launched to a wider audience and this submission is for the campaign evaluation. Palliative Care: Conversations Matter addresses the communications challenges faced by health care providers who recommend and provide palliative care to pediatric populations. NINR is launching this effort to increase the use of palliative care for children living with serious illnesses or life-limiting conditions. The campaign surveys are designed to collect feedback from health care providers who are involved in pediatric palliative care to ensure that the information and materials being disseminated as part of the campaign are effective, relevant, and useful to health care providers. Information obtained through this assessment is needed by NINR to evaluate the campaign and to obtain guidance for future campaign efforts. Respondents to this survey will be health care providers at up to ten hospitals who work with children living with serious illnesses or life-limiting conditions. 2016-10-31-04:00 Active Saleda Perryman No No No 600 200 0

Physicians No Health Health Care Services
1 PRE AND POST SURVEYS Yes Yes Fillable Fileable Form and instruction Attachment 2_Pre and Post Surveys_Screenshots.pdf
Individuals or Households 300 100 0

Nurses No Health Health Care Services
1 PRE AND POST SURVEYS Yes Yes Fillable Fileable Form and instruction Attachment 2_Pre and Post Surveys_Screenshots.pdf
Individuals or Households 300 100 0

2013-10-30-04:00

0925-0684 201309-0925-002 0925
             
        "Awareness and Beliefs About Cancer (ABC) Survey"
             
          
        
The objective of the proposed study is gather data about American adults' awareness and beliefs about cancer. The ultimate goal is to determine how individuals' perceptions of cancer may influence their decisions to report signs and symptoms to health care providers, perhaps affecting the disease stage of diagnosis and the effectiveness of treatment. 2014-11-30-05:00 Active Mikia Currie 3014350941 No No No 10000 1334 0

ABC Screener (Attachment 2) No Health Consumer Health and Safety
1 ABC Survey-Screener No No Fillable Fileable Form Attach2_ABC Screener_5-1-2013.docx
Individuals or Households 8000 667 0

Awarness and Beliefs About Cancer (ABC) Study Survey (Attachment 3) No Health Consumer Health and Safety
2 Awareness and Beliefs about Cancer (ABC) Study Survey Yes Yes Fillable Fileable Form Attach3_ABC Survey_6-6-2013.docx
Individuals or Households 2000 667 0

2013-11-07-05:00

0925-0685 201311-0925-001 0925
             
        "Web-based Media Literacy Parent Training for  Substance Use Prevention in Rural Locations"
             
          
        
The goal of this project is to evaluate a media literacy substance use prevention intervention, Media Detective Family, for parents and their school-aged children using a randomized controlled trial and establish MDF as an evidence-based intervention. MDF reduces barriers to prevention efforts in rural areas by delivering the intervention on an interactive website or a mobile or wireless devise. MDF focuses on improving children's alcohol and tobacco use knowledge and intentions, and adults' and children's media literacy knowledge and skills. A total of approximately 200 parent-child pairs will be recruited from 6 rural counties in North Carolina and Texas, with 100 pairs randomly assigned to each condition (intervention/control). Information will be collected on knowledge, norms, skills, behavior, behavioral intentions, and demographic characteristics of participating children and adults. Data collection using audio computer-assisted self interviewing will occur at three time points: at pretest, after using MDF or a control computer program for one month, and at 3-month follow-up. Benefits will include improvements in critical thinking skills and parent-child communication about substances and the media, and an increase in rural families receiving evidence-based prevention programming. 2015-11-30-05:00 Active Saleda Perryman No No No 2000 1067 0

Permission and Consent Form No Health Health Care Services
1 Consent Form Yes Yes Fillable Fileable Form and instruction Attachment 14 Consent and permission forms.docx
Individuals or Households 200 33 0

Child Assent Form No Health Health Care Services
2 Child Assent Yes Yes Fillable Fileable Form and instruction Attachment 15 Assent Form.docx
Individuals or Households 200 33 0

Adult Pretest - Screenshot No Health Health Care Services
3 Adult Pretest -Screenshot Yes Yes Fillable Fileable Form Attachment 18 - Screenshot Adult Pretest - MDF.zip
Individuals or Households 200 167 0

Adult Post-test - Screenshot No Health Health Care Services
4 Adult Post-test -Screenshot Yes Yes Fillable Fileable Form Attachment 20 - Screenshot Adult Posttest - MDF.zip
Individuals or Households 200 150 0

Adult Follow-up - Screenshot No Health Health Care Services
5 Adult Follow-up Yes Yes Fillable Fileable Form Attachment 22 - Screenshot Adult Followup - MDF.zip
Individuals or Households 200 150 0

Adults Programs Usage Log No Health Health Care Services
6 Adults Usage Log Yes Yes Fillable Fileable Form Attachment 16 Data Collection Instrument_Adults Program Usage Log.docx
Individuals or Households 400 67 0

Child Pretest - Screenshot No Health Health Care Services
10 Child Pretest Yes Yes Fillable Fileable Form Attachment 24 - Screenshot Child Pretest - MDF.zip
Individuals or Households 200 167 0

Child Posttest -Screenshot No Health Health Care Services
11 Child Posttest Yes Yes Fillable Fileable Form Attachment 26 - Screenshot Child Posttest - MDF.zip
Individuals or Households 200 150 0

Child Followup- Screenshot No Health Health Care Services
12 Child Followup Yes Yes Fillable Fileable Form Attachment 28 - Screenshot Child Followup - MDF.zip
Individuals or Households 200 150 0

2013-11-21-05:00

0925-0686 201309-0925-005 0925
             
        "The Family Life, Activity, Sun, Health, and Eating Study (NCI)"
             
          
        
The FLASHE Study takes a dyadic approach to examine psychosocial, generational (parent-adolescent), and environmental correlates of cancer preventive behaviors. FLASHE will examine the science of cancer and obesity prevention by examining correlates of cancer preventive behaviors, mainly diet, activity, and sedentary behaviors (but also examining other behaviors such as sleep, sun-safety, and tobacco) in new ways not previously addressed comprehensively on other surveys in samples of parents and their adolescent children. The survey's goal is to advance understanding of the dynamic relationship between the environment, psychosocial factors, and cancer preventive behaviors from a dyadic perspective. Data collected will ultimately be a public use dataset and resource to the research community. FLASHE will be collecting data from parents and their adolescent children using a web survey format with a final estimated sample size of 2,500 dyads, with motion sensing data collected in a subsample of 900 adolescents. 2015-12-31-05:00 Active Mikia Currie 3014350941 No No No 11900 2243 0

Parent Self-Enrollment and Consent Instrument (Attachment F) No Health Consumer Health and Safety
1 Parent Self-Enrollment and Consent Instrument (Attachment F) Yes Yes Fillable Fileable Form Attach F - Parent Self-Enrollment Instrument.docx
Individuals or Households 1250 208 0

Parental Enrollment and Consent Instrument for Adolescent (Attachment G1) No Health Consumer Health and Safety
2 Parental Enrollment and Consent Instrument for Adolescent (Attachment G1) Yes Yes Fillable Printable Form Attach G1 - Parent Enrollment of Adolescent Instrument.docx
Individuals or Households 1250 208 0

Adolescent Assent Instrument (Attachment G2) No Health Consumer Health and Safety
3 Adolescent Assent Instrument (Attachment G-2) Yes Yes Fillable Fileable Form Attach G2 - Adolescent Assent Instrument.docx
Individuals or Households 1250 104 0

Adult Physical Activity Survey Instrument (Attachment H) No Health Consumer Health and Safety
4 Adult Physical Activity Survey Instrument (Attachment-H) https://www.research-survey.org/efm/wsb.dll/s/1g37 Yes Yes Fillable Fileable Form Attach H - Adult PA Instrument.docx
Individuals or Households 1250 417 0

Adolescent Physical Activity Survey Instrument (Attachment I) No Health Consumer Health and Safety
5 Adolescent Physical Activity Survey Instrument (Attachment I) https://www.research-survey.org/efm/wsb.dll/s/1g3e Yes Yes Fillable Fileable Form Attach I - Adolescent PA Instrument.docx
Individuals or Households 1250 417 0

Adult Diet Survey Instrument (Attachment J) No Health Consumer Health and Safety
6 Adult Diet Survey Intrument (Attachment J) https:/www.research-survey.org/efm/wsb.dll/s/1g3c Yes Yes Fillable Fileable Form Attach J - Adult Diet Instrument.docx
Individuals or Households 1250 313 0

Adolescent Diet Survey Instrument (Attachment K) No Health Consumer Health and Safety
7 Adolescent Diet Survey Instrument (Attachment K) https://ww.research-survey.org/efm/wsb.dll/s/1g3d Yes Yes Fillable Fileable Form Attach K - Adolescent Diet Instrument.docx
Individuals or Households 1250 313 0

Wear Log Instrument (Attachment L) No Health Consumer Health and Safety
8 Wear Log Instrument (Attachment L) No No Paper Only Form and instruction Attach L - Wear Log Instrument.pdf
Individuals or Households 3150 263 0

2013-12-13-05:00

0925-0687 201310-0925-002 0925
             
        "Interactive Informed Consent for Pediatric Clinical Trials"
             
          
        
Interactive Informed Consent for Pediatric Clinical Trials. This study will compare parents' and children's understanding of information about a hypothetical clinical trial presented using either a standard paper consent document or an interactive computer-based consent program. Parents' and children's understanding, regardless of whether they received the standard consent or the interactive computer-based program, will be by assessed by face-to-face interview. In addition, parents' and children's perceptions of, and satisfaction with, the information presented will be evaluated by completion of a short questionnaire. The primary hypothesis to be tested is that interactive computer-based research consent information is better understood and accepted by parents and children compared with the standard paper consent document. Given that many individuals have difficulty reading and interpreting standard written consent documents, this technology holds promise as a means to optimize the consent and assent process particularly among individuals with low literacy and numeracy skills. Respondents will interviewed to assess their baseline understanding of key elements of a clinical trial e.g., randomization, blinding, etc. They will then be randomized to either the standard paper consent or the interactive computer-based consent. Immediately after they will be tested again for their understanding of the key elements and interviewed to assess their understanding of the clinical trial details. 2015-12-31-05:00 Active Mikia Currie 3014350941 No No No 1988 173 0

Children Script consent No Health Health Care Services
1 Script Consent No Paper Only Form Attachment 7 Script Consent.docx
Individuals or Households 136 2 0

Children Pre-test interview No Health Health Care Services
1 Pre-Test No Paper Only Form Attachment 1a Pretest.docx
Individuals or Households 136 7 0

Children Post-test 1C interview No Health Health Care Services
1 Post-test 1C Interview No Paper Only Form Attachment 1c post test questions.docx
Individuals or Households 136 7 0

Children Post-test 1B interview No Health Health Care Services
1 Post-test 1B interview No Paper Only Form Attachment 1b post test interview.docx
Individuals or Households 136 27 0

Children Perceptions of the program No Health Health Care Services
1 Perceptions No Paper Only Form Attachment 2 Perceptions Questionnaire.docx
Individuals or Households 136 20 0

Children SORT-R3 for literacy No Health Health Care Services
1 SORT R3 No Paper Only Form Attachment 3 Sort R-3.pdf
Individuals or Households 136 11 0

Children SNS for numeracy No Health Health Care Services
No Paper Only Other Screenshot 3.pdf No Paper Only Other Screenshot 1.pdf No Paper Only Other Screenshot 2.pdf 1 SNS for Numeracy No Paper Only Form Attachment 4 SNS Questionnaire.docx
Individuals or Households 136 9 0

Parents Script consent No Health Health Care Services
1 Script Consent No Paper Only Form Attachment 7 Script Consent.docx
Individuals or Households 148 2 0

Parents Pre-test interview No Health Health Care Services
1 Pre-Test No Paper Only Form Attachment 1a Pretest.docx
Individuals or Households 148 7 0

Parents Post-test 1C interview No Health Health Care Services
1 Post-test 1C Interview No Paper Only Form Attachment 1c post test questions.docx
Individuals or Households 148 7 0

Parents Post-test 1B interview No Health Health Care Services
1 Post-test 1B interview No Paper Only Form Attachment 1b post test interview.docx
Individuals or Households 148 30 0

Parents Perceptions of the program No Health Health Care Services
1 Perceptions No Paper Only Form Attachment 2 Perceptions Questionnaire.docx
Individuals or Households 148 22 0

Parents SORT-R3 for literacy No Health Health Care Services
1 SORT R3 No Paper Only Form Attachment 3 Sort R-3.pdf
Individuals or Households 148 12 0

Parents SNS for numeracy No Health Health Care Services
No Paper Only Other Screenshot 1.pdf No Paper Only Other Screenshot 3.pdf No Paper Only Other Screenshot 2.pdf 1 SNS for Numeracy No Paper Only Form Attachment 4 SNS Questionnaire.docx
Individuals or Households 148 10 0

2013-12-26-05:00

0925-0688 201311-0925-003 0925
             
        "Evaluation of a Kidney Disease Education Program with Promotores in the Hispanic Community"
             
          
        
The National Kidney Disease Education Program (NKDEP) of the National Institutes of Health is evaluating a community kidney disease education program developed for promotores (community health workers) who teach Hispanics about diabetes care. Data for a pilot project and national dissemination of the materials will be collected through pretest and posttest surveys and in-depth interviews to finalize the draft educational and training materials and to assess the partiicipants' change in knowledge and awareness and reported behavior and health status. Without this information, NKDEP risks the possibility of inefficiently and ineffectively implementing its program with untested materials when disseminated nationally. 2015-12-31-05:00 Active Saleda Perryman No No No 441 101 0

Promotores (training pre-test, post-test, and qualitative in-depth interview post client session) No Health Immunization Management
1 Training pre-test post-test No No Paper Only Form and instruction Attachment 1 Promotores Training Pre-test and Post-test Survey.docx
Individuals or Households 12 1 0

Promotores (client pre-test, post-test, and second post-tests for experimenta and control groups) No Health Immunization Management
2 Client pre-test, pot-test, and second post-tests for experimental control groups No No Paper Only Form and instruction Attachment 3 Client Pre-test and Post-test Survey.docx
Individuals or Households 340 85 0

Client Group (pre-test, post-test, second post-tests for experimental and control groups) No Health Immunization Management
2 Client pre-test, pot-test, and second post-tests for experimental control group No No Paper Only Form and instruction Attachment 3 Client Pre-test and Post-test Survey.docx
Individuals or Households 85 14 0

Client Group (qualitative In-depth interview) No Health Immunization Management
3 In-depth Interview No No Paper Only Form and instruction Attachment 4 Client In-depth Interview Guide.docx
Individuals or Households 4 1 0

2013-12-31-05:00

0925-0689 201312-0925-001 0925
             
        "Electronic Application for NIH Certificates of Confidentialty (CoC E-application System)"
             
          
        
The recruitment of human research subjects into NIH funded studies is critical to the success of the agency's mission to enhance health, lengthen life, and reduce the burdens of illness and disability. However, human research subjects are often concerned about the potential negative consequences of access to their research data by individuals outside the research team. This situation can make it difficult to recruit subjects for research projects on sensitive topics. Recognizing this problem, in 1970, Congress enacted legislation to permit the Department of Health and Human Services (DHHS) to issue Certificates of Confidentiality (CoCs) to authorize covered researchers to protect the privacy of research subjects by withholding their names and identifying characteristics from those not connected with the research. The legislation was initially limited to research on the use and effect of drugs. Since then, the scope of the CoC legislation has been expanded several times, most recently in 1988. 1997, DHHS delegated the authority to issue CoCs to NIH and the other DHHS agencies that fund research. The Director of NIH further delegated this authority within NIH to the individual NIH Institutes and Centers (ICs). NIH's Office of Extramural Research (OER) is responsible for coordinating this activity across NIH. The information to be collected via the electronic CoC application system will be used by the NIH IC's to determine eligibility for a CoC and to help create the actual Certificate that will be issued to the requesting organization. Additionally, the system will assist NIH staff with the administrative management of requests, for example, by tracking progress of requests and key dates (receipt of request, issuance of CoC, expiration dates. Additionally, OER will use the data from the system for routine internal program monitoring for NIH. 2017-01-31-05:00 Active Saleda Perryman No No No 1000 1500 0

CoC Applicants - Private Sector No Health Public Health Monitoring
1 CoC Online Application (Screenshots) Yes Yes Fillable Printable Form and instruction NETE_OD_OEP_HumanSubjects_Aug13 (2).pdf
Private Sector 400 600 0

CoC Applicants- State and Local No Health Public Health Monitoring
1 CoC On-line Application ( Screenshots) Yes Yes Fillable Fileable Form and instruction NETE_OD_OEP_HumanSubjects_Aug13 (2).pdf
State, Local, and Tribal Governments 450 675 0

CoC Applicants- Small Business No Health Public Health Monitoring
1 CoC On-line Application (Screenshots) Yes Yes Fillable Fileable Form and instruction NETE_OD_OEP_HumanSubjects_Aug13 (2).pdf
Private Sector 50 75 0

CoC Applicants- Federal No Health Public Health Monitoring
1 CoC On-line Application (Screenshots) Yes Yes Fillable Fileable Form and instruction NETE_OD_OEP_HumanSubjects_Aug13 (2).pdf
Federal Government 100 150 0

2014-01-02-05:00

0925-0690 201312-0925-007 0925
             
        "Outcomes Evaluation of the National Cancer Institute (NCI) Cancer Prevention Fellowship Program (CPFP)"
             
          
        
This is a request for OMB to approve the new submission titled, "Outcomes Evaluation of the National Cancer Institute Cancer Prevention Fellowship Program" for 1 year. The National Cancer Institute's (NCI) Cancer Prevention Fellowship Program (CPFP) mission is to train early career scientists from diverse disciplines to become outstanding independent researchers and leaders. This postdoctoral program conducted on-site at NCI has been in existence for over 25 years and has approximately 200 alumni. Despite its long existence, there has not been a comprehensive systematic, formal evaluation of career outcomes of CPFP trainees in the history of the program at NCI. The current study will focus on the implementation of a new survey instrument to capture career outcomes from CPFP alumni and two comparison groups, CPFP applicants and NCI F32 awardees. With the diversity of disciplines represented by CPFP alumni, the results of this evaluation will be of broad interest to the biomedical research training community. 2015-01-31-05:00 Active Saleda Perryman No No No 550 197 0

Attachment 1 - Survey of Alumni No Health Consumer Health and Safety
1 SURVEY OF ALUMNI Yes Yes Fillable Fileable Form and instruction Attach 1B.Survey of Alumni (Word Document).11-5-13.docx
Individuals or Households 160 67 0

Attachment 2 - Survey of Applicants No Health Consumer Health and Safety
2 SURVEY OF APPLICANTS Yes Yes Fillable Fileable Form and instruction Attach 2B.Survey of Applicants (Word Document).11-5-13.docx
Individuals or Households 170 57 0

Attachment 3 - Survey of F32 Awardees No Health Consumer Health and Safety
3 Survey of F32 Awardees Yes Yes Fillable Fileable Form and instruction Attach 3B.Survey of F32 Awardees (Word Document).11-5-13.docx
Individuals or Households 220 73 0

2014-01-27-05:00

0925-0691 201401-0925-002 0925
             
        "Ethical Dilemmas in Surgery and Utilization of Hospital Ethics Consulation Service:  A Survey "
             
          
        
This survey is intended to collect information about the ethical dilemmas that surgeons have faced in their practices over the past year, and assess their experiences, if any, with their hospital consultation services. Specifically, the information gathered in this study will be valuable in understanding the ethical dilemmas that surgeons face, the utility of institution ethics consultations services for surgeons, and to identify what barriers, if any, discourage surgeons from utilizing these services. The results of this study can be used by medical professionals, hospitals, and bioethicists in several important ways. First, they will provide a better understanding the ethical dilemmas that surgeons face in their practices. Second, they will provide understanding of factors that determine the current utilization of hospital consultation services by surgeons. Third, information collected on the barriers to surgeons' use of ethics consultation services will provide better insight into the perspective and culture of surgery as it relates to ethical dilemmas in their practices and how ethics consultation services could better support surgeons when faced with these dilemmas. 2016-01-31-05:00 Active Saleda Perryman No No No 598 150 0

Surgeons Ethical Survey Form No Health Public Health Monitoring
1 National Survey on Ethical Dlilemmas in Surgery No No Paper Only Form and instruction Survey Surgeon Ethics 1-3-14.doc
Individuals or Households 598 150 0

2014-01-27-05:00

0925-0692 201310-0925-003 0925
             
        "Quantification of Behavioral and Physiological Effects of Drugs Using a Mobile Scalable Device"
             
          
        
This ICR is to test the effectiveness of a mobile scalable device to detect the impairing effects of different drugs on driving data. Participant's cognitive functioning associated with impaired driving due to stimulant or depressant usage will be monitored in a laboratory setting. Participants will be exposed to one of three substances amp;#8211; Adderal, Xanax, or Cannabis amp;#8211; that are commonly used recreationally, and then "drive" in a simulator. The findings will enable evaluation of the reliability of the device and its algorithms in quantifying the effects of stimulant and depressant drug use, and will provide valuable information concerning the utility and effectiveness of mobile, Smartphone/tablet-based neurocognitive assessment. The device will enable a multifactorial evaluation of cognitive functioning associated with impaired driving. The tool will be applicable worldwide, and will facilitate epidemiological, comparative studies of drugged driving. 2016-02-29-05:00 Active Mikia Currie 3014350941 No No No 1408 859 0

Adults- Phone Screening No Health Health Care Services
2 Adults - Consent Process Adderall Yes Yes Fillable Fileable Form Attachment 10(Informed Consent In-person Screening- Adderall).pdf 1 Adults- Phone Screening Yes Yes Fillable Fileable Form and instruction Attach1(MSD_PhoneScreening).doc
Individuals or Households 100 17 0

Adults - Consent Process, In-Person Screening Adderall No Health Health Care Services
2 Adults- Consent Process, In-Person Screening Adderall Yes Yes Fillable Fileable Form Attachment 10(Informed Consent In-person Screening- Adderall).pdf
Individuals or Households 100 75 0

Adults -Consent Process, In-Person Screening Xanax No Health Health Care Services
3 Adults - Consent Process,in-Person Screening Xanax Yes Yes Fillable Fileable Form Attachment 11(Informed Consent In-person Screening -Xanax) .pdf
Individuals or Households 100 75 0

Adults-Consent Process, In-Person Screening Cannabis No Health Health Care Services
4 Adults - In-Person Screening Cannabis Yes Yes Fillable Fileable Form Attachment 12(Informed Consent In-person Screening -Cannabis).pdf
Individuals or Households 100 75 0

Adults- Sleep and Intake Questionnaire No Health Illness Prevention
7 Adu;ts Sleep and Intake Questionnaire Yes Yes Fillable Fileable Form Attachment 3 Sleep and Food Intake Survey.doc
Individuals or Households 144 7 0

Adults- Stanford Sleepiness Scale No Health Health Care Services
8 Adults- Stanford Sleepiness Scale Yes Yes Fillable Fileable Form Attachment 4 Stanford Sleepiness Scale.doc
Individuals or Households 432 7 0

Adults - Dosing/Driving/Waiting/ - (Intervention) No Health Health Care Services
13 Informed Consent - Cannabis Yes Yes Fillable Fileable Form and instruction Attachment 12(Informed Consent In-person Screening -Cannabis).pdf 12 Informed Consent - Xanax Yes Yes Fillable Fileable Form and instruction Attachment 11(Informed Consent In-person Screening -Xanax) .pdf 11 Informed Consent- Adderall Yes Yes Fillable Fileable Form and instruction Attachment 10(Informed Consent In-person Screening- Adderall).pdf
Individuals or Households 144 576 0

Driving Survey -Screenshot No Health Health Care Services
8 Driving Survey Screenshot Yes Yes Fillable Fileable Form Attachment 7 Screenshot of MSD-Driving Survey.pdf
Individuals or Households 72 18 0

Realism Survey - Screenshot No Health Health Care Services
9 Realism Survey Screenshot No No Fillable Fileable Form Attachment 8 Screenshot of MSD -Realism Survey.pdf
Individuals or Households 72 4 0

Wellness Survey Screenshot No Health Health Care Services
10 Wellness Survey Screenshot Yes Yes Fillable Fileable Form Attachment 9 Screenshot of MSD-Wellness Survey.pdf
Individuals or Households 144 5 0

2014-02-06-05:00

0930-0092 201307-0930-001 0930
             
        "Confidentiality of Alcohol and Drug Abuse Patient Records - 42 CFR Part 2"
             
          
        
Statutes require Federally conducted, regulated, or directly or indirectly assisted alcohol and drug abuse programs to keep patient records confidential. Information requirements are (1) written disclosure to patients, and (2) documenting "medical personnel" status of recipients of a disclosure to meet a medical emergency. 2016-09-30-04:00 Active Summer King 2402761243 No No No 2018080 402788 92477

42 CFR 2.22 No Health Public Health Monitoring State, Local, and Tribal Governments 1994632 398872 92477

42 CFR 2.51 No Health Public Health Monitoring State, Local, and Tribal Governments 23448 3916 0

2013-09-24-04:00

0930-0106 201210-0930-005 0930
             
        "National Survey of Substance Abuse Treatment Services (N-SSATS)"
             
          
        
There has been a name change for this data collection; from "DASIS" to the "National Survey of Substance Abuse Treatment Services (N SSATS)." N-SSATS is the main survey component from the prior collection which provides both national and state-level data on the numbers and types of patients treated and the characteristics of facilities providing substance abuse treatment services. 2016-01-31-05:00 Active Summer King 2402761243 No No No 29440 11535 0

Drug and Alcohol Services Information System - TEDS Admission No Health Public Health Monitoring
TEDS TEDS Yes Yes Paper Only Form and instruction TEDS.zip
Private Sector 0 0 0

Drug and Alcohol Services Information System - TEDS Discharge No Health Public Health Monitoring
TEDS TEDS Yes Yes Paper Only Form and instruction TEDS.zip
Private Sector 0 0 0

I-BHS No Health Public Health Monitoring
I-BHS Online forms I-BHS Online forms Yes Yes Fillable Printable Form and instruction Attachment A1 - I-BHS Online forms.pdf
State, Local, and Tribal Governments 7840 627 0

I-BHS Application No Health Public Health Monitoring
I-BHS Facility application form I-BHS Facility application form Yes Yes Fillable Printable Form and instruction Attachment A2 - I-BHS Facility application form.pdf
State, Local, and Tribal Governments 600 48 0

N-SSATS No Health Public Health Monitoring
N-SSATS 2013 web screens for on-line questionnaire N-SSATS 2013 web screens for on-line questionnaire Yes Yes Fillable Printable Form and instruction Attachment B3 - N-SSATS 2013 web screens for on-line questionnaire.pdf N-SSATS 2013 full questionnaire N-SSATS 2013 full questionnaire Yes Yes Fillable Printable Form and instruction Attachment B1 - N-SSATS 2013 full questionnaire.docx N-SSATS 2013 CATI Questionnaire N-SSATS 2013 CATI Questionnaire Yes Yes Fillable Printable Form and instruction Attachment B4 - N-SSATS 2013 CATI Questionnaire.pdf
State, Local, and Tribal Governments 17000 9860 0

Augmentation Screener No Health Public Health Monitoring
Augmentation screener questionnaire Augmentation screener questionnaire Yes Yes Fillable Printable Form and instruction Attachment A3 - Augmentation screener questionnaire.docx
State, Local, and Tribal Governments 2000 160 0

N-SSATS BC No Health Public Health Monitoring
N-SSATS 2014 abbreviated questionnaire N-SSATS 2014 abbreviated questionnaire Yes Yes Fillable Printable Form and instruction Attachment B2 - N-SSATS 2014 abbreviated questionnaire.docx
State, Local, and Tribal Governments 2000 840 0

Drug and Alcohol Services Information System - TEDS Discharge Crosswalks No Health Public Health Monitoring
TEDS TEDS Yes Yes Paper Only Form and instruction TEDS.zip
Private Sector 0 0 0

2013-01-15-05:00

0930-0110 201307-0930-002 0930
             
        "2014 National Survey on Drug Use and Health (NSDUH)"
             
          
        
The NSDUH (formerly the National Household Survey on Drug Abuse) is a survey of the civilian, noninstitutionalized population of the United States, age 12 and over. The data are used to estimate the prevalence of cigarette, alcohol and illicit drug use, and abuse of licit drugs. Results are used by SAMHSA, ONDCP, and other Federal agencies and other researchers and organizations to establish policy, direct program activities, and better allocate resources. 2016-09-30-04:00 Active Summer King 2402761243 No No No 200389 78317 0

Household Screening No Health Public Health Monitoring
Screening Questions Screening Questions Yes Yes Fillable Fileable Form and instruction HS - Att F - 2014 Screening Questions.pdf
Individuals or Households 119181 9892 0

Interview No Health Public Health Monitoring
2014 CAI Questionnaire 2014 CAI Questionnaire Yes Yes Fillable Fileable Form and instruction I - Att O - 2014 CAI Questionnaire Revised 031913.pdf
Individuals or Households 67507 67507 0

Screening Verification No Health Public Health Monitoring
Telephone Verification Scripts Telephone Verification Scripts Yes Yes Fillable Fileable Form and instruction SV and IV - Att R - 2014 Telephone Verification Scripts.pdf
Individuals or Households 3575 240 0

Interview Verification No Health Public Health Monitoring
Telephone Verification Scripts Telephone Verification Scripts Yes Yes Fillable Fileable Form and instruction SV and IV - Att R - 2014 Telephone Verification Scripts.pdf
Individuals or Households 10126 678 0

2013-09-20-04:00

0930-0119 201205-0930-001 0930
             
        "2012 National Mental Health Services Survey (N-MHSS)"
             
          
        
The 2010 N-MHSS differs from the previous version of the survey in the following ways: (a) to facilitate completing the survey online, definitions of terms and other survey information will be offered at the survey website; (b) the eligibility criteria for inclusion in the survey, previously outlined in a flyer accompanying the survey, have now been incorporated into the questionnaire as screening questions; and (c) the questionnaire has been reorganized for greater simplicity and shortened by eliminating several questions identified as no longer relevant. 2015-06-30-04:00 Active Summer King 2402761243 No No No 16500 6930 0

Primary Data Collection No Health Public Health Monitoring
Locator Questionnaire Locator Questionnaire Yes Yes Paper Only Form and instruction Attachment A1 - Questionnaire.docx
Private Sector 15000 6300 0

New Facilities No Health Public Health Monitoring
Locator Questionnaire Locator Questionnaire Yes Yes Paper Only Form and instruction Attachment A1 - Questionnaire.docx
Private Sector 1500 630 0

2012-06-28-04:00

0930-0158 201007-0930-002 0930
             
        "Mandatory Guidelines for Federal Workplace Drug Testing Programs"
             
          
        
The Federal Drug Testing Custody and Control Form is used for the Mandatory Guidelines required to in the chain of custody procedures to document the integrity and security of a urine specimen from the time it is collected until it is received by the laboratory. 2014-02-28-05:00 Active Summer King 2402761243 No No Uncollected 28384153 1786809 2212000

Donor No Health Public Health Monitoring
Federal CCF Federal CCF Yes No Paper Only Form and instruction Attachment D.pdf
Federal Government 7096000 567680 2212000

Collector No Health Public Health Monitoring
Federal CCF Federal CCF Yes No Paper Only Form and instruction Attachment D.pdf
Federal Government 7096000 496720 0

Laboratory No Health Public Health Monitoring
Federal CCF Federal CCF Yes No Paper Only Form and instruction Attachment D.pdf
Federal Government 7096000 354800 0

Medical Review Officer No Health Public Health Monitoring
Federal CCF Federal CCF Yes No Paper Only Form and instruction Attachment D.pdf
Federal Government 7096000 354800 0

Laboratory Application No Health Public Health Monitoring
Urine Lab Appl. Form Urine Lab Appl. Form Yes Yes Paper Only Form and instruction Attachment E.pdf Urine Lab Info Checklist Form Urine Lab Info Checklist Form Yes Yes Paper Only Form and instruction Attachment F.pdf Urine IITF Appl. Form Urine IITF Appl. Form Yes Yes Paper Only Form and instruction Attachment G.pdf Urine IITF Info Checklist Form Urine IITF Info Checklist Form Yes Yes Paper Only Form and instruction Attachment H.pdf
Federal Government 3 9 0

Laboratory Inspection Checklist No Health Public Health Monitoring
Urine Lab Appl. Form Urine Lab Appl. Form Yes Yes Paper Only Form and instruction Attachment E.pdf Urine Lab Info Checklist Form Urine Lab Info Checklist Form Yes Yes Paper Only Form and instruction Attachment F.pdf Urine IITF Appl. Form Urine IITF Appl. Form Yes Yes Paper Only Form and instruction Attachment G.pdf Urine IITF Info Checklist Form Urine IITF Info Checklist Form Yes Yes Paper Only Form and instruction Attachment H.pdf
Federal Government 100 300 0

Laboratory Recordkeeping No Health Public Health Monitoring
Urine Lab Appl. Form Urine Lab Appl. Form Yes Yes Paper Only Form and instruction Attachment E.pdf Urine Lab Info Checklist Form Urine Lab Info Checklist Form Yes Yes Paper Only Form and instruction Attachment F.pdf Urine IITF Appl. Form Urine IITF Appl. Form Yes Yes Paper Only Form and instruction Attachment G.pdf Urine IITF Info Checklist Form Urine IITF Info Checklist Form Yes Yes Paper Only Form and instruction Attachment H.pdf
Federal Government 50 12500 0

2010-08-29-04:00

0930-0168 201210-0930-002 0930
             
        "Uniform Application for the Community MH Services BG and SAPT BG Application Guidance and Instructions FY 2014-2015"
             
          
        
SAMHSA's SAPTBG and MHSBG are designed to provide States with the flexibility to design and implement activities and services to address the complex needs of individuals, families, and communities impacted by mental disorders, substance use disorders and associated problems. The goals of the Block Grant programs are consistent with SAMHSA's vision for a high-quality, self-directed, and satisfying life in the community for everyone in America. 2016-05-31-04:00 Active Summer King 2402761243 No No No 119 37429 0

Application No Health Health Care Services
Yes Yes Printable Only Instruction Public Burden Statement.doc Reporting Reporting Yes Yes Fillable Printable Form and instruction 2014_BGrepts_4-29-13 clean.pdf Certifications Certifications Yes Yes Fillable Printable Form and instruction Attachment A3 - Certifications.pdf Planning Planning Yes Yes Fillable Printable Form and instruction BG application 5-21-13 FINAL.pdf
State, Local, and Tribal Governments 119 37429 0

2013-05-21-04:00

0930-0169 201105-0930-004 0930
             
        "Protection and Advoccy of Individuals With Mental Illness (PAIMI) Annual Program Performance Report"
             
          
        
The PAIMI formula grant program provides funds to support activities on behalf of individuals with mental illness. Recipients of program funding are required by law to report annually such information as the number of indivdiuals served, types of facilities involved, and their priorities, activities and accomplishments. The PAIMI Annual Program Performance Report must also include a separate report prepared by the PAIMI Advisory Council describing its activities and assessing the operation of the protection and advocacy system. 2014-08-31-04:00 Active Summer King 2402761243 No No No 114 2052 0

Annual Program Performance Report No Health Public Health Monitoring
Attachment B1 FY 2011 Attachment B1 FY 2011 Yes Yes Paper Only Form and instruction Attachment B1 FY 2011 - 2014 8.12.11-FINAL.doc
State, Local, and Tribal Governments 57 1482 0

Advisory Council Report No Health Public Health Monitoring
Attachment B2- PAIMI ACR Section Attachment B2- PAIMI ACR Section Yes Yes Paper Only Form and instruction Attachment B2- PAIMI ACR Section 8.12.11-FINAL.docm
State, Local, and Tribal Governments 57 570 0

2011-08-12-04:00

0930-0172 201304-0930-001 0930
             
        "Protection and Advocacy for Individuals with Mental Illness Regulations -- 45 CFR Part 51"
             
          
        
State and Territory protection and advocacy systems receive formula grant funds to protect and provide advocacy services for individuals with mental illness who are residents of facilities providing care and treatment. The rule provides guidance to State protection and advocacy systems regarding submission of reports on the activities of protection and advocacy programs, as required under the Protection and Advocacy for Mentally Ill Individuals (PAIMI) Act (42 USC 10801 et seq.). Burden for the annual reports is approved under OMB control number 0930-0169. 2016-06-30-04:00 Active Summer King 2402761243 No No No 142 184 0

51.10 No Health Public Health Monitoring
Statement Statement No No Paper Only Form There are no instruments to this data collection.doc
State, Local, and Tribal Governments 7 56 0

51.10 No Health Public Health Monitoring
Statement Statement No No Paper Only Form There are no instruments to this data collection.doc
State, Local, and Tribal Governments 21 42 0

51.23(c) No Health Public Health Monitoring
Statement Statement No No Paper Only Form There are no instruments to this data collection.doc
State, Local, and Tribal Governments 57 57 0

51.25(b)(3) No Health Public Health Monitoring
Statement Statement No No Paper Only Form There are no instruments to this data collection.doc
State, Local, and Tribal Governments 57 29 0

2013-06-28-04:00

0930-0195 201012-0930-001 0930
             
        "Participant Feedback Forms for the Mental Health Care Provider Education (MHCPE) in the HIV/AIDS Program"
             
          
        
These standardized forms will collect systematic feedback from trainees participating in the Minority HIV/AIDS Mental Health Treatment and Education Services Program and the Mental Health Care Provider Education in HIV/AIDS III Program. The overall goal of the two programs is to help create a cadre of traditional and non-traditional mental health service providers who utilize state-of-the-art information on the psychological and neuropsychological sequelae of HIV/AIDS, and to enhance the nation's ability to have an impact on the HIV/AIDS epidemic. 2014-03-31-04:00 Active Summer King 2402761243 No No No 12600 1843 0

Session Report Form No Health Public Health Monitoring
Session Report Form Session Report Form Yes Yes Paper Only Form March 2011 Session Reporting Form 0403_001.pdf Session Report Form Session Report Form Yes Yes Paper Only Form Yes Yes Paper Only Instruction SRF Instructions Sheet.pdf
State, Local, and Tribal Governments 600 48 0

Participant Feedback Form No Health Public Health Monitoring
Yes Yes Paper Only Instruction PFF Instructions.pdf Participant Feedback Form Participant Feedback Form Yes Yes Paper Only Form March 2011 Participant Overall Fdbk Form 0402_001.pdf
State, Local, and Tribal Governments 5000 835 0

Neuropsychiatric Participant Feedback No Health Public Health Monitoring
Neuropsychiatric Participant Feedback Neuropsychiatric Participant Feedback Yes Yes Paper Only Form March 2011 Neuropsych Fdbk Form 0403_001.pdf Yes Yes Paper Only Instruction NPFF Instructions.pdf
State, Local, and Tribal Governments 4000 668 0

Adherence Participant Feedback Form No Health Public Health Monitoring
Adherence Participant Feedback Adherence Participant Feedback Yes Yes Paper Only Form March 2011 Adherence Fdbk Form 0399_001.pdf Yes Yes Paper Only Instruction APFF Instructions.pdf
State, Local, and Tribal Governments 1000 167 0

Ethics Participant Feedback Form No Health Public Health Monitoring
Ethics Participant Feedback Form Ethics Participant Feedback Form Yes Yes Paper Only Form March 2011 Ethics Fdbk Form 400_001.pdf Yes Yes Paper Only Instruction EPFF Instructions.pdf
State, Local, and Tribal Governments 2000 125 0

2011-03-18-04:00

0930-0196 201306-0930-003 0930
             
        "Pretesting of Substance Abuse Prevention and Treatment and Mental Health Services Communications Messages"
             
          
        
This submission is for generic approval for pretesting of educational and information materials for various consumer publics and the professional communities in the areas of substance abuse prevention, addiction treatment, and mental health services. To assure that brochures, posters, information kits, public service announcements, videos news releases, web site and direct response messages communicate their messages effectively to the intended components of the population it is essential to pretest them to assure that they are received, understood, and accepted by those for whom they are intended. 2016-09-30-04:00 Active Summer King 2402761243 No No No 11700 9290 0 2013-09-18-04:00

0930-0197 201401-0930-001 0930
             
        "Voluntary Customer Satisfaction Surveys to Implement Executive Order 12862 in the Substance Abuse and Mental Health Services Administration (SAMHSA)"
             
          
        
SAMHSA provides significant services directly to the public, including treatment providers and State substance abuse agencies, through a range of mechanisms, including publications, technical assistance and web sites. Many of these services are focused on information dissemination activities. The purpose of this submission is to obtain generic approval for satisfaction surveys of our customers. 2017-01-31-05:00 Active Summer King 2402761243 No No No 90000 23063 0 2014-01-08-05:00

0930-0205 201209-0930-003 0930
             
        "Annual Reports for Projects for Assistance in Transition from Homelessness (PATH)"
             
          
        
The PATH program provides funding to help States and territories provide flexible, community-based services for individuals with serious mental illnesses who are homeless or at imminent risk of becoming homeless. There is a statutory requirement that States and territories receiving funding under this formula grant program provide a report not later than January 31 a description of the purposes for which funds were expended during the preceding fiscal year and of the recipients of the monies, and determining whether such amounts were expended in accordance with the provisions of the legislation. 2016-01-31-05:00 Active Summer King 2402761243 No No No 559 18166 0

Annual Reports for Projects for Assistance in Transition from Homelessness (PATH) No Health Illness Prevention
Yes Yes Printable Only Instruction Attachment B PATH Annual Report Provider Guide.pdf PATH Online Provider Annual Report Form PATH Online Provider Annual Report Form Yes Yes Fillable Printable Form Attachment A_PATH Online Provider Annual Report Form_2.pdf
State, Local, and Tribal Governments 559 18166 0

2013-01-08-05:00

0930-0206 201303-0930-002 0930
             
        "Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction - 42 CFR Part 8"
             
          
        
These regulations specify requirements for opioid treatment programs, which must apply for certification and adhere to recordkeeping, disclosure and reporting specifications. In addition, entities that wish to become accreditation bodies under the regulations must apply to and obtain approval from SAMHSA. Such bodies must develop and submit accreditation elements for SAMHSA acceptance. Upon designation as an accreditation body, entities must keep certain records of accreditation surveys and submit them to SAMHSA. 2016-06-30-04:00 Active Summer King 2402761243 No No No 26001 2263 0

Reporting - Opioid Treatment Programs No Health Public Health Monitoring
SMA-168 SMA-168 Yes Yes Fillable Printable Form and instruction SMA-168.pdf SMA-162 SMA-162 Yes Yes Fillable Printable Form and instruction SMA-162.pdf
State, Local, and Tribal Governments 24594 1869 0

Reporting - Accreditation Bodies No Health Public Health Monitoring
SMA-163 SMA-163 Yes Yes Fillable Printable Form and instruction SMA-163.pdf
State, Local, and Tribal Governments 1407 394 0

2013-06-28-04:00

0930-0208 201302-0930-003 0930
             
        "Government Performance and Results Act Client/Participant Outcome Measures"
             
          
        
SAMHSA uses the performance measures to report on the performance of its discretionary services grant programs. The information is used by individuals at three different levels: the SAMHSA administrator and staff, the Center administrators and government project officers, and grantees. 2015-05-31-04:00 Active Summer King 2402761243 No No No 1061956 85498 0

GPRA Client Outcome No Health Illness Prevention
GPRA Client Outcome Instrument GPRA Client Outcome Instrument Yes Yes Paper Only Form and instruction Attachment 1 CSAT GPRA Client Outcome Instrument new questions OMB 3-1-10_v 3.doc
State, Local, and Tribal Governments 1061956 85498 0

2013-11-15-05:00

0930-0216 201304-0930-002 0930
             
        "National Cross-Site Assessment of Addiction Technology Transfer Centers (ATTC) Network"
             
          
        
The ATTC Network is a nationwide, multi-disciplinary resource that draws upon the knowledge, experience, and latest research of recognized experts in the field of addictions. The network is comprised of 14 ATTCs representing all States, the District of Columbia, Puerto Rico, the Virgin Islands and the Pacific Islands and a National Office to coordinate cross-site activities. Training activities, meetings and technical assistance are provided to treatment professionals through the network. The National Cross-Site Assessment will obtain pre-event, followup, and post event information from all participants. 2016-09-30-04:00 Active Summer King 2402761243 No No No 42750 6663 0

ATTC - Event Description Form No Health Public Health Monitoring
Event Description Form Event Description Form Yes Yes Paper Only Form and instruction Attachment.1.Event.Description.Form.doc
State, Local, and Tribal Governments 250 63 0

ATTC - TA - Post Event No Health Public Health Monitoring
Post Event Forms Post Event Forms Yes Yes Paper Only Form and instruction PostEvent.zip GPRA GPRA Yes Yes Paper Only Form and instruction GPRA.zip
State, Local, and Tribal Governments 5000 600 0

ATTC - Training - Post Event No Health Public Health Monitoring
Post Event Forms Post Event Forms Yes Yes Paper Only Form and instruction PostEvent.zip
State, Local, and Tribal Governments 30000 4800 0

ATTC - Training Follow-up No Health Public Health Monitoring
Follow-up Form Follow-up Form Yes Yes Paper Only Form and instruction Attachment.3.Training.Followup.Form.doc
State, Local, and Tribal Governments 7500 1200 0

2013-09-11-04:00

0930-0222 201303-0930-001 0930
             
        "Substance Abuse Prevention and Treatment Block Grant Synar Report Format, FY 2014-2016"
             
          
        
This is the annual report format to implement regulations at 45 CFR96.130 regarding States' compliance with Section 1926 of the Public Health Service Act (42 USC 300x-26) related to sale or distribution of tobacco products to minors. 2016-05-31-04:00 Active Summer King 2402761243 No No No 59 1062 0

Annual Synar Report Format No Health Public Health Monitoring
Yes Yes Fillable Printable Instruction B-FFY 2014 ASR Instructions.docx Report Format Report Format Yes Yes Fillable Printable Form FFY 2014 ASR_proposed_4_30_13.docx
State, Local, and Tribal Governments 59 1062 0

2013-05-07-04:00

0930-0229 201102-0930-003 0930
             
        "Emergency Response Grants - 42 CFR Part 51"
             
          
        
These regulations implement new section 501(m) of the Public Health Service Act which authorizes noncompetitive grants to public entities to enable them to address emergency substance abuse or mental health needs in local communities. Two types of awards are available. The regulations establishes criteria for determining when a mental health or substance abuse emergency exists and specifies application and reporting requirements. 2014-05-31-04:00 Active Summer King 2402761243 No No No 6 0 0

Emergency Response Grants - 42 CFR Part 51 No Health Public Health Monitoring State, Local, and Tribal Governments 6 0 0

2011-05-12-04:00

0930-0230 201302-0930-004 0930
             
        "National Outcome Measures for Substance Abuse Prevention"
             
          
        
CSAP is identifying recommended core measures for priority prevention constructs for use with different demographic groups. Grantees receiving initial funding will be expected to use measures that are appropriate to their prevention intervention project. This effort will strengthen accountability by standardizing and improving the quality of data available across grantees and programs. Grantees will report their data semi-annually to their respective data coordinating centers, which will submit the data to CSAP's data coordinating center. 2015-05-31-04:00 Active Summer King 2402761243 No No No 133781 53512 0

CSAP/NOMs No Health Public Health Monitoring
NOMs Instruments NOMs Instruments Yes Yes Fillable Printable Form and instruction 128Attachment B NOMs Instruments (FINAL).docx
State, Local, and Tribal Governments 133781 53512 0

2013-11-15-05:00

0930-0234 201204-0930-001 0930
             
        "Notification of Intent to Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate Addiction"
             
          
        
The Drug Addiction Treatment Act of 2000 establishes conditions for physicians to obtain waivers to permit them to prescribe certain approved narcotic treatment medications for the maintenance or detoxification treatment of opiod addiction. 2015-07-31-04:00 Active Summer King 2402761243 No No No 2050 149 0

Notification of Intent to Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate Addiction No Health Public Health Monitoring
Attachment B - SMA-167 Attachment B - SMA-167 Yes Yes Paper Only Form and instruction TAB B-SMA-167_Increase_Patients-07-19-12.pdf
Private Sector 2050 149 0

2012-07-22-04:00

0930-0242 201305-0930-001 0930
             
        "Regulations to Implement SAMHSA's Charitable Choice Statutory Provisions:  42 CFR Parts 54 and 54a"
             
          
        
Section 1955 of the Public Health Service Act (42 USC 300x-65), as amended by the Children's Health Act of 2000 (Pub. L. 106-310) and Sections 581-584 of the Public Health Service Act (42 USC 290kk et. seq., as added by the Consolidated Appropriations Act (Pub. L. 106-554)), set forth various provisions which aim to ensure that religious organizations are able to compete on an equal footing for Federal funds to provide substance abuse services. The regulations ensure that SAMHSA substance abuse programs are neutral with regard to the religious character of participating organizations and establish clearly the proper uses to which funds may be put and the conditions for receipt of funding. SAMHSA also provided a model "Notice to Individuals Receiving Substance Abuse Services" for use by religious organizations to inform program beneficiaries or potential beneficiaries who object to the religious character of that program participant that they have the right to referral to an alternate provider. 2016-07-31-04:00 Active Summer King 2402761243 No No No 2418 2186 58783

42 CFR Parts 54 No Health Public Health Monitoring Private Sector 818 708 0

42 CFR Parts 54 a No Health Public Health Monitoring Private Sector 1600 1478 58783

2013-07-23-04:00

0930-0255 201306-0930-001 0930
             
        "SAMHSA Application for Peer Grant Reviewers"
             
          
        
Section 501(h) of the Public Health Service (PHS) Act [42 USC 290aa] directs the Administrator of SAMHSA to establish such peer review groups as are needed to carry out the requirements of Title V of the PHS Act. SAMHSA administers a large discretionary grants program under authorization of Title V, and for many years SAMHSA has funded grants to provide prevention and treatment services related to substance abuse and mental heatlh. SAMHSA efforts to make improvements in the grants process have been shown by the restructuring of discretionary award announcement. 2016-08-31-04:00 Active Summer King 2402761243 No No No 500 750 0

SAMHSA Application for Peer Grant Reviewers No Health Public Health Monitoring
Application Application Yes Yes Fillable Printable Form and instruction RCI_4.5.2013_V2.pdf
Individuals or Households 500 750 0

2013-08-02-04:00

0930-0266 201105-0930-003 0930
             
        "Access to Recovery (ATR) Program"
             
          
        
ATR grantees will report financial and outcomes data on a quarterly basis. Financial data will be used to monitor costs and ensure that funds are being used for appropriate and intended purposes. Outcome data will be used to measure the success of clinical treatment and recovery support services and measure the success of the voucher program. 2014-07-31-04:00 Active Summer King 2402761243 No No No 80000 2400 0

Voucher Tool No Health Health Care Services
Voucher Information and Transaction Voucher Information and Transaction Yes Yes Paper Only Form and instruction Attachment A Voucher Information and Transaction.doc
State, Local, and Tribal Governments 80000 2400 0

2011-07-18-04:00

0930-0270 201203-0930-002 0930
             
        "Toolkit Protocol for the Crisis Counseling Assistance and Training Program (CCP)"
             
          
        
Data collection about services delivered and users of the services will be collected from the CCPs through standardized information tools which will then be reported to SAMHSA for appropriate processing and analysis. CCPs will be required to use the tools for data collection throughout the life of the program. 2015-08-31-04:00 Active Summer King 2402761243 No No No 53000 7622 0

Individual/Family Crisis Counseling Servies Encounter Log No Health Illness Prevention
N/A Individual Family Encounter Form Yes Yes Paper Only Form and instruction Attachment_A_IndividualFamilyEncounterForm 7.31.12.docx
State, Local, and Tribal Governments 39200 5096 0

Group Encounter Log No Health Illness Prevention
N/A Group Encounter Log Yes Yes Paper Only Form and instruction Attachment_B_GroupEncounterLog 7.31.12.docx
State, Local, and Tribal Governments 3300 231 0

Weekly Tally Sheet No Health Illness Prevention
N/A Weekly Tally Sheet Yes Yes Paper Only Form and instruction Attachment_C_WeeklyTallySheet 7.31.12.docx
State, Local, and Tribal Governments 6600 1320 0

Asessment and Referral Tool No Health Illness Prevention
N/A Adult Assessment and Referral tool Yes Yes Paper Only Form and instruction Attachment_D_AdultAssessmentandReferralTool 7.31.12.docx N/A Child Youth Assessment and Referral Tool Yes Yes Paper Only Form and instruction Attachment_E_ChildYouthAssessmentandReferralTool 7.31.12.docx
State, Local, and Tribal Governments 2800 700 0

Particpant Feedback Form No Health Illness Prevention
N/A Participant Feedback Form Yes Yes Paper Only Form and instruction Attachment I_ParticipantFeedbackForm 7.31.12.docx
State, Local, and Tribal Governments 1000 250 0

Service Provider Feedback Form No Health Illness Prevention
N/A Service Provider Feedback Form Yes Yes Paper Only Form and instruction Attachment J_ServiceProviderFeedbackForm 7.31.12.docx
State, Local, and Tribal Governments 100 25 0

2012-08-17-04:00

0930-0274 201302-0930-001 0930
             
        "Monitoring of National Suicide Prevention Lifeline Form"
             
          
        
The National Suicide Prevention Lifeline--Call Monitoring Form collect information on the caller, the elements of a suicide risk assessment that are completed by the crisis worker, as well as what action plan that is developed with the caller and what referrals are provided to the caller. Additionally, the evaluation includes follow-up data collection utilizing the Crisis Hotline Telephone Follow-up Assessment. The purpose of this assessment is to collect data regarding: (1) suicide risk status at the time of and since the call, (2) depressive symptoms at follow-up, (3) service utilization since the call, (4) barriers to service access, and (5) the caller's perception of the efficacy of the hotline intervention. 2016-07-31-04:00 Active Summer King 2402761243 No No No 3131 649 0

MI/SP Caller Initial Script No Health Public Health Monitoring
CallerI Initial Script CallerI Initial Script Yes Yes Fillable Printable Form and instruction Attachment A_CallerI Initial Script.pdf
Individuals or Households 500 40 0

MI/SP Caller Follow-up Consent Script No Health Public Health Monitoring
Client Follow-up Consent Script Client Follow-up Consent Script Yes Yes Fillable Printable Form and instruction Attachment B_Client Follow-up Consent Script.pdf
Individuals or Households 369 63 0

MI/SP Caller Follow-up Interview No Health Public Health Monitoring
Caller Follow-up Interview Caller Follow-up Interview Yes Yes Fillable Printable Form and instruction Attachment C_Caller Follow-up Interview.pdf
Individuals or Households 369 247 0

MI/SP Counselor Consent No Health Illness Prevention
Counselor Consent Counselor Consent Yes Yes Fillable Printable Form and instruction Attachment D_Counselor Consent.pdf
Individuals or Households 250 20 0

MI/SP Counselor Attitudes Questionnaire No Health Illness Prevention
Attitudes Questionnaire Attitudes Questionnaire Yes Yes Fillable Printable Form and instruction Attachment E_Counselor Attitudes Questionnaire.pdf
Individuals or Households 250 63 0

MI/SP Counselor Follow-up Questionnaire No Health Illness Prevention
Follow-up Questionnaire Follow-up Questionnaire Yes Yes Fillable Printable Form and instruction Attachment F_Counselor Follow up Questionnaire.pdf
Individuals or Households 1250 213 0

MI/SP Caller Initial Script Refusal No Health Health Care Services
CallerI Initial Script CallerI Initial Script Yes Yes Fillable Printable Form and instruction Attachment A_CallerI Initial Script.pdf
Individuals or Households 121 2 0

MI/SP Caller Follow-up Consent Script Refusal No Health Consumer Health and Safety
Client Follow-up Consent Script Client Follow-up Consent Script Yes Yes Fillable Printable Form and instruction Attachment B_Client Follow-up Consent Script.pdf
Individuals or Households 21 1 0

MI/SP Caller Follow-up Interview Refusal No Health Consumer Health and Safety
Caller Follow-up Interview Caller Follow-up Interview Yes Yes Fillable Printable Form and instruction Attachment C_Caller Follow-up Interview.pdf
Individuals or Households 1 0 0

2013-07-23-04:00

0930-0276 201109-0930-005 0930
             
        "Cross-Site Evaluation of the National Child Traumatic Stress Initiative (NCTSI)"
             
          
        
The NCTSI comprises of a nationwide network of grantees involved in diverse ways with improving access to care raising the standard of care for children exposed to trauma. Data is collected on information on the traumatized children's events, support they are receiving, and interventions and treatment they are receiving. 2014-12-31-05:00 Active Summer King 2402761243 No No No 87849 22789 0

Core Clinical Characteristics Forms-Baseline and Follow-up No Health Public Health Monitoring
Baseline Baseline Yes Yes Paper Only Form and instruction Attachment C.1 CDS Baseline Form_2.doc Followup Followup Yes Yes Paper Only Form and instruction Attachment C.2 CDS Follow-Up Form_2.doc
State, Local, and Tribal Governments 12972 4281 0

Trauma Information /Detail Form No Health Public Health Monitoring
Detail Form Detail Form Yes Yes Paper Only Form and instruction Attachment C.3 CDS General & Trauma Detail Form.pdf
State, Local, and Tribal Governments 12972 2854 0

Core Clinical Characteristics Form No Health Public Health Monitoring
CBCL 6-18 CBCL 6-18 Yes Yes Paper Only Form and instruction Attachment C.5 CBCL 6-18.pdf CBCL 1.5 to 5 CBCL 1.5 to 5 Yes Yes Paper Only Form and instruction Atttachment C.4 CBCL 1.5 to 5.pdf
State, Local, and Tribal Governments 12972 6486 0

USLA-PTSD Short Form No Health Public Health Monitoring
UCLA PTSD UCLA PTSD Yes Yes Paper Only Form and instruction Attachment C.6 UCLA PTSD Index for DSM IV.pdf
State, Local, and Tribal Governments 9860 1676 0

Trauma Symptoms Checklist for Young Children No Health Public Health Monitoring
TSCYC TSCYC Yes Yes Paper Only Form and instruction Attachment C.8 TSCYC Briere.PDF
State, Local, and Tribal Governments 3632 1199 0

Parenting Stress Index No Health Public Health Monitoring
PSI Short Form PSI Short Form Yes Yes Paper Only Form and instruction Attachment C.9 PSI Short Form.PDF
State, Local, and Tribal Governments 3892 311 0

Trauma Symptoms Checklist for Children Abbreviated No Health Public Health Monitoring
TSCC_A TSCC_A Yes Yes Paper Only Form and instruction Attachment C.7 TSCC_A Briere.pdf
State, Local, and Tribal Governments 8172 2697 0

Children Depression Inventory No Health Public Health Monitoring
CDI-2S CDI-2S Yes Yes Paper Only Form and instruction Attachment C.10 CDI-2S.pdf
State, Local, and Tribal Governments 2852 228 0

Global Appraisal of Individual Needs Modified Shore Screener No Health Public Health Monitoring
GAIN-MSS GAIN-MSS Yes Yes Paper Only Form and instruction Attachment C.11 GAIN-MSS.doc
State, Local, and Tribal Governments 5320 426 0

Online Performance Monitoring Report No Health Public Health Monitoring
OPMR OPMR Yes Yes Paper Only Form and instruction Attachment E_OPMR.doc
State, Local, and Tribal Governments 248 149 0

Sustainability Survey for Currently Funded Centers No Health Public Health Monitoring
Sustainability_Funded Centers Sustainability_Funded Centers Yes Yes Paper Only Form and instruction Attachment I.1_Sustainability_Funded Centers.doc
State, Local, and Tribal Governments 62 17 0

EBP/ETSC Administrator No Health Public Health Monitoring
EBP/ETSC EBP/ETSC Yes Yes Paper Only Form and instruction Attachment D.1_ETSC_Administrators.doc
State, Local, and Tribal Governments 186 56 0

Training Summary Form No Health Public Health Monitoring
Training Summary Form Training Summary Form Yes Yes Paper Only Form and instruction Attachment G_Training Summary Form.doc
State, Local, and Tribal Governments 248 50 0

EBP/ETSC Provider No Health Public Health Monitoring
ETSC_Providers ETSC_Providers Yes Yes Paper Only Form and instruction Attachment D.2_ETSC_Providers.docx
State, Local, and Tribal Governments 496 149 0

Training Sign-in Sheet No Health Public Health Monitoring
Training Sign-in Sheet Training Sign-in Sheet Yes Yes Paper Only Form and instruction Attachment H_Training Sign-in Sheet.docx
State, Local, and Tribal Governments 9920 198 0

National Research Survey No Health Public Health Monitoring
National Reach Survey National Reach Survey Yes Yes Paper Only Form and instruction Attachment F_National Reach Survey.doc
State, Local, and Tribal Governments 4000 2000 0

Sustainability Survey Affiliate Centers No Health Public Health Monitoring
Sustainability Survey Sustainability Survey Yes Yes Paper Only Form and instruction Attachment I.2_Sustainability Survey_Affiliate Centers.doc
State, Local, and Tribal Governments 45 12 0

2011-12-11-05:00

0930-0277 201209-0930-002 0930
             
        "Targeted Capacity Expansion Grants for Jail Diversion Programs"
             
          
        
The Jail Diversion Programs divert individuals with mental illness and often co-occurring disordes in contact with the justice system from jail and provide linkages to community- based traetment and support servies. The individual thus avoids or spends a significantly reduce time in jail and/or lockups on the current charge or on violations of probation resulting from previous charges. 2016-01-31-05:00 Active Summer King 2402761243 No No No 7511 1145 0

Targeted Capacity Expansion Grants for Jail Diversion Programs - Baseline No Health Public Health Monitoring
Baseline Interview Baseline Interview Yes Yes Fillable Printable Form and instruction A Baseline Interview 12.27.12.pdf
State, Local, and Tribal Governments 378 243 0

Targeted Capacity Expansion Grants for Jail Diversion Programs- 6 Months No Health Public Health Monitoring
Six Month Interview Six Month Interview Yes Yes Fillable Printable Form and instruction B 6-Month Interview 12.27.12.pdf
State, Local, and Tribal Governments 302 278 0

Targeted Capacity Expansion Grants for Jail Diversion Programs - 12 Months No Health Public Health Monitoring
Twelve Month Interview Twelve Month Interview Yes Yes Fillable Printable Form and instruction C 12- Month Interview 12.27.12.pdf
State, Local, and Tribal Governments 283 260 0

Targeted Capacity Expansion Grants for Jail Diversion Programs - Events Tracking No Health Public Health Monitoring
Event Tracking Screen Event Tracking Screen Yes Yes Fillable Printable Form and instruction D Event Screening 12.27.12.pdf
State, Local, and Tribal Governments 5000 150 0

Targeted Capacity Expansion Grants for Jail Diversion Programs - Person Tracking No Health Public Health Monitoring
Tracking Information Form Tracking Information Form Yes Yes Fillable Printable Form and instruction E Baseline Person Tracking Information Form 12.27.12.pdf
State, Local, and Tribal Governments 500 36 0

Targeted Capacity Expansion Grants for Jail Diversion Programs - Service Use No Health Public Health Monitoring
Service Use Data Collection Form Service Use Data Collection Form Yes Yes Fillable Printable Form and instruction F Service Use Data Collection Form 12.27.12.pdf
State, Local, and Tribal Governments 500 85 0

Targeted Capacity Expansion Grants for Jail Diversion Programs - Arrest History No Health Public Health Monitoring
Arrest Data Collection Form Arrest Data Collection Form Yes Yes Fillable Printable Form and instruction G Arrest Data Collection Form 12.27.12.pdf
State, Local, and Tribal Governments 500 85 0

Targeted Capacity Expansion Grants for Jail Diversion Programs - Submission No Health Public Health Monitoring State, Local, and Tribal Governments 48 8 0

2013-01-08-05:00

0930-0285 201302-0930-002 0930
             
        "Transformation Accountability (TRAC) Reporting System"
             
          
        
This data activity is to provide a level of consistency with the NOMs domain in SAMHSA-wide data collection and reporting of performance measures across all of its Centers and programs. This particular activity will promote the use of consistent measures among CMHS programs, grantees and contractors funded through the Programs of Regional and National Significance (PRNS) and the Children Mental Health Initiative (CMHI) budget lines. The Consumer NOMs recommended by CMHS are a result of extensive examination and recommendations, by panels of staff, experts, and grantees. Wherever feasible, the proposed measures are consistent with or build upon previous data development efforts within CMHS. 2015-05-31-04:00 Active Summer King 2402761243 No No No 19449 29298 0

Client-Level No Health Illness Prevention
Adult Measures Adult Measures Yes Yes Paper Only Form and instruction SVCS_AdultTool_11.19.13.docx Child Measures Child Measures Yes Yes Paper Only Form and instruction SVCS_ChildCombinedTool_11.19.13.docx
State, Local, and Tribal Governments 15681 14226 0

Infrastructure, Development, Prevention MH Abstraction No Health Public Health Monitoring
Result Form Result Form Yes Yes Paper Only Form and instruction Attachment 3 IPP_RESULT FORM.docx
State, Local, and Tribal Governments 3768 15072 0

2013-11-19-05:00

0930-0286 201308-0930-001 0930
             
        "Cross-Site Evaluation of the Garrett Lee Smith Memorial Suicide Prevention and Early Intervention Program"
             
          
        
The information collected through the four stages of the cross-site evaluation of the GLS Suicide Prevention and Early Intervention Programs will describe for State/Tribal grantees (1) the context in which suicide prevention activities are being implemented, (2) the products and services funded through the program, (3) the training experiences of individuals who receive training as part of the suicide prevention programs, (4) the utilization and penetration of the skills, knowledge and techniques learned through suicide prevention training programs, and (5) the referral networks in place to support youth identified at risk for suicide. 2017-01-31-05:00 Active Summer King 2402761243 No No No 20347 8014 0

Project Evaluators - State/Tribal No Health Public Health Monitoring
H1. EIRF Analysis Form (EIRF) H1. EIRF Analysis Form (EIRF) Yes Yes Fillable Fileable Form and instruction H1. EIRF Analysis Form (EIRF).docx
State, Local, and Tribal Governments 873 1603 0

Providers - State/Tribal - Trainees No Health Public Health Monitoring
D3 TUP-S Verbal Consent Script D3 TUP-S Verbal Consent Script Yes Yes Fillable Fileable Form and instruction D9. TUP-S-6 Month Instrument and Verbal Consent.docx D2. Training Utilization and Preservation Survey D2. Training Utilization and Preservation Survey Yes Yes Fillable Fileable Form and instruction D2. Training Utilization and Preservation Survey_Consent to Contact Form_Formatted.docx D9. TUP-S-6 Month Instrument and Verbal Consent D9. TUP-S-6 Month Instrument and Verbal Consent Yes Yes Fillable Fileable Form and instruction D9. TUP-S-6 Month Instrument and Verbal Consent.docx
State, Local, and Tribal Governments 3467 395 0

Project Evaluators - Campus No Health Public Health Monitoring
Campus-Project Evaluator Instruments Campus-Project Evaluator Instruments Yes Yes Fillable Printable Form and instruction Campus-Project Evaluator Instruments.pdf
State, Local, and Tribal Governments 720 280 0

Student - Campus No Health Public Health Monitoring
I3. LAFI Verbal Consent Script.doc I3. LAFI Verbal Consent Script.doc Yes Yes Fillable Fileable Form and instruction I3. LAFI Verbal Consent Script.doc J.1 SAIS Baseline Instrument and Web Consent.docx J.1 SAIS Baseline Instrument and Web Consent.docx Yes Yes Fillable Fileable Form and instruction J.1 SAIS Baseline Instrument and Web Consent.docx I2. LAFI Consent to Contact Form.doc I2. LAFI Consent to Contact Form.doc Yes Yes Fillable Fileable Form and instruction I2. LAFI Consent to Contact Form.doc J.2 SAIS Follow-up Instrument and Web Consent.docx J.2 SAIS Follow-up Instrument and Web Consent.docx Yes Yes Fillable Fileable Form and instruction J.2 SAIS Follow-up Instrument and Web Consent.docx D5. TUP-S Campus Consent-to-Contact Form.docx D5. TUP-S Campus Consent-to-Contact Form.docx Yes Yes Fillable Fileable Form and instruction D5. TUP-S Campus Consent-to-Contact Form.docx D6. TUP-S Campus Verbal Consent.doc D6. TUP-S Campus Verbal Consent.doc Yes Yes Fillable Fileable Form and instruction D6. TUP-S Campus Verbal Consent.doc I1. LAFI Instrument.doc I1. LAFI Instrument.doc Yes Yes Fillable Fileable Form and instruction I1. LAFI Instrument.doc
State, Local, and Tribal Governments 8802 3709 0

Campus Staff - Campus No Health Public Health Monitoring
Campus Staff Instruments Campus Staff Instruments Yes Yes Paper Only Form and instruction A8 Campus Staff Instruments.pdf
Private Sector 0 0 0

Providers - Campus - Trainees No Health Public Health Monitoring
Campus--Provider (Trainees) Instruments Campus--Provider (Trainees) Instruments Yes Yes Fillable Printable Form and instruction Campus--Provider (Trainees) Instruments.pdf
State, Local, and Tribal Governments 4333 737 0

Student - Campus Case No Health Public Health Monitoring
Student Instruments Student Instruments Yes Yes Paper Only Form and instruction A11 CCS - Student Instruments.pdf
Private Sector 0 0 0

Campus Staff - Campus Case No Health Public Health Monitoring
Campus Staff Instruments Campus Staff Instruments Yes Yes Paper Only Form and instruction A13 CCS - Campus Staff Instruments.pdf
Private Sector 0 0 0

Adolescents - State/Tribal - Trainees No Health Public Health Monitoring
D7.Training Utilization and Preservation Survey D7.Training Utilization and Preservation Survey (TUP-S-A)- Adolescent Version.docx Yes Yes Fillable Fileable Form and instruction D7.Training Utilization and Preservation Survey (TUP-S-A)- Adolescent Version.docx D8. TUP-S-A Consent-to-Contact D8. TUP-S-A Consent-to-Contact and Youth Assent Forms.docx Yes Yes Fillable Fileable Form and instruction D8. TUP-S-A Consent-to-Contact and Youth Assent Forms.docx
State, Local, and Tribal Governments 300 48 0

Provider - State/Tribal - Stakeholder No Health Public Health Monitoring
G. Coalition Survey Instrument and Web Consent G. Coalition Survey Instrument and Web Consent.docx Yes Yes Fillable Fileable Form and instruction G. Coalition Survey Instrument and Web Consent.docx E. RNS Instrument and Verbal Consent Script.docx E. RNS Instrument and Verbal Consent Script.docx Yes Yes Fillable Fileable Form and instruction E. RNS Instrument and Verbal Consent Script.docx
State, Local, and Tribal Governments 1852 1242 0

2014-01-09-05:00

0930-0288 201309-0930-001 0930
             
        "Assessment of the Underage Drinking Prevention: Town Hall Meetings Initiative"
             
          
        
SAMHSA/CSAP intends to support annual Town Hall Meetings (THMs). The information collected will be used by SAMHSA/CSAP to help plan for those annual events and to provide technical assistance and training to organizations that sponsor the events. The information will provide a descriptive picture of the nation-wide initiative, and it will indicate how the THMs were received and some factors that may be associated with well-received events. 2017-01-31-05:00 Active Summer King 2402761243 No No No 6720 1113 0

Organizers Survey No Health Public Health Monitoring
Organizer Survey Organizer Survey Yes Yes Fillable Printable Form and instruction Attachment 1-Organizer Survey_052313.doc
State, Local, and Tribal Governments 2220 739 0

Participants Survey No Health Public Health Monitoring
Participant Form_English Participant Form_English Yes Yes Fillable Printable Form and instruction Attachment 2-Participant Form_English_052313.doc Participant Form_Spanish Participant Form_Spanish Yes Yes Fillable Printable Form and instruction Attachment 3-Participant Form_Spanish_052313.doc
State, Local, and Tribal Governments 4500 374 0

2014-01-02-05:00

0930-0290 201103-0930-001 0930
             
        "National Survey on Drug Use and Health:  Methodological Field Tests"
             
          
        
Field test will be designed to examine the feasibility, quality, and efficiency of new prodedures or revisions to existing survey protocol. Specifically, the tests will measure the reliability and validity of certain questionnaire sections and items through multiple measurements on a set of respondents; assess new methods for gaining cooperation and participation of respondents with the goal of increasing response and decreasing potential bias in the survey estimates; and assess the impact of new sampling techniques and technologies on respondent behavior and reporting. Research will involve household survey interviews and cognitive interviewing. 2014-05-31-04:00 Active Summer King 2402761243 No No No 5905 2750 0

Cognitive Interviews for Questionnaire Redesign No Health Illness Prevention
Protocol and Specs Protocol and Specs Yes Yes Paper Only Form and instruction Attachment E - Protocol and Specs_revised.docx
Individuals or Households 50 66 0

2011-05-18-04:00

0930-0295 201206-0930-001 0930
             
        "Rapid HIV Testing Clinical Information Form for Minority AIDS Initiative (MAI) for Ethnic Racial Minorities at Risk for Substance Use and HIV/AIDS"
             
          
        
The data on the MAI Rapid HIV Testing Clinical Information Form will be used to collect clinical information that can be used for quality assurance, quality performance, and product monitoring. The form does not require patient specific information to be collected from parties participating in the MAI program. The form is designed to inform SAMHSA that the HIV Rapid Test Kits are reaching their intended audience, as many communities have expressed an interest in acquiring these no cost test kits to assist them in informing and protecting their citizens. The information that we require, will also serve to justify the use of Federal funds to benefit the American Indian/Alaska Native community. 2015-11-30-05:00 Active Summer King 2402761243 No No No 64000 9576 0

HIV/AID Rapid Testing Clinical Information Form No Health Public Health Monitoring
Attachment A - HIV Form Attachment A - HIV Form Yes Yes Fillable Printable Form and instruction Attachment A-RHT Data Collection Tool v2.pdf
State, Local, and Tribal Governments 64000 9576 0

2012-11-21-05:00

0930-0297 201109-0930-002 0930
             
        "The Safe School/Healthy Student (SS/HS) Initiative National Evaluation "
             
          
        
The three Federal agencies collaborating on the Initiative share an expectation that LEAs and communities nationwide will benefit from the documented experiences of the grantees. A letter to introduce the National Evaluation Team (NET) was mailed to all grantees from the Director of the Division of Prevention, Traumatic Stress and Special Programs at SAMHSA. The NET has developed instruments to collect detailed quantitative and qualitative data on the grant activities and the local collaborative process. These instruments all apply to the local Project Director of the grant, the local project evaluator, one representative of each local organization that formally partners in the administration of the grant activities, one representative of each school receiving services through this grant, and instructional and administrative staff at targeted schools. 2014-11-30-05:00 Active Summer King 2402761243 No No No 28125 4973 0

Staff School Climate Survey No Health Public Health Monitoring
Staff School Climate Survey Staff School Climate Survey Yes Yes Paper Only Form and instruction 7. Staff School Climate Survey.doc
State, Local, and Tribal Governments 25200 2948 0

School Level Survey No Health Public Health Monitoring
School-Level Survey School-Level Survey Yes Yes Paper Only Form and instruction 6. School-Level Survey.doc
State, Local, and Tribal Governments 2300 966 0

Project Level Survey No Health Public Health Monitoring
Project-Level Survey Project-Level Survey Yes Yes Paper Only Form and instruction 5. Project-Level Survey.doc
State, Local, and Tribal Governments 100 42 0

Partnership Inventory No Health Public Health Monitoring
Partnership Inventory Partnership Inventory Yes Yes Paper Only Form and instruction 4. Partnership Inventory.doc
State, Local, and Tribal Governments 400 100 0

Baseline Assessment Survey No Health Public Health Monitoring
Baseline Assessment Baseline Assessment Yes Yes Paper Only Form and instruction 2. Baseline Assessment.doc
State, Local, and Tribal Governments 25 17 0

Site Visit Protocol No Health Public Health Monitoring
Site Visit Protocol Site Visit Protocol Yes Yes Paper Only Form and instruction 3. Site Visit Protocol.doc
State, Local, and Tribal Governments 100 900 0

2011-11-18-05:00

0930-0298 201208-0930-001 0930
             
        "Minority Substance Abuse/HIV Prevention Initiative"
             
          
        
The Youth and Adult Minority Substance Abuse Questionnaires will be used to survey populations at risk for Substance Abuse, HIV/AIDS, and hepatitis. The participants are those in the Program who receive direct services for over 30 days at three time points: (1) baseline (program entry), (2) program exit, and (3) three to six months post-exit. 2016-02-29-05:00 Active Summer King 2402761243 No No No 20512 15049 0

Adult No Health Public Health Monitoring
Adult Questionnaire Adult Questionnaire Yes Yes Printable Only Form HIV Adult Questionnaire_120321.docx
State, Local, and Tribal Governments 16820 12340 0

Youth No Health Public Health Monitoring
Youth Questionnaire Youth Questionnaire Yes Yes Fillable Printable Form HIV Youth Questionnaire_120321.docx
State, Local, and Tribal Governments 3692 2709 0

2013-02-10-05:00

0930-0300 201212-0930-001 0930
             
        "Enhancing Substance Abuse Treatment Services to Address Hepatitis Infection Among Intravenous Drug Users Hepatitis Testing and Vaccine Tracking Form "
             
          
        
The information collected on the Form will solicit and reflect the following information: 1)Demographics (age, gender, ethnicity) of designated OTP site 2)History (Screening) of Hepatitis C exposure 3)Results of Rapid Hepatitis C Testing (Kit) and Follow-up information 4)Service Provided (type of vaccine given) Divalent vaccine (Twinrix- combination HAV and HBV) or Monovalent vaccine ( HAV or/and HBV) 5)Substance Abuse Treatment Outcomes (Information regarding the beginning, continuing or completion of vaccination series) 6)Type of Referral Services Indicated (ie; Gastroenterology, TB; Mental Health, Counseling, Reproductive/Prenatal, etc.) 2016-03-31-04:00 Active Summer King 2402761243 No No No 800 40 0

SAMHSA/CSAT's Viral Hepatitis Information Form No Health Public Health Monitoring
Yes Yes Fillable Printable Instruction 0300-Public Burden Statement.doc Hepatitis Reporting Form Hepatitis Reporting Form Yes Yes Fillable Printable Form Attachment A. 3-14-13.docx Hepatitis Reporting Form Hepatitis Reporting Form Yes Yes Fillable Printable Form
State, Local, and Tribal Governments 800 40 0

2013-03-20-04:00

0930-0307 201206-0930-002 0930
             
        "National Evaluation of the Comprehensive Mental Health Services for Children and Their Families Program: Phase VI"
             
          
        
The Community Mental Health Servies Program for Children with Serious Emotional Distrubances supports a broad array of community-based and family-centered services delivered through the system of care model. Most data collection instruments and procedures are built upon those used in the evaluation of Phase VI grantees. 2015-09-30-04:00 Active Summer King 2402761243 No No No 232582 40024 0

The Nat'l Eval. of theComprehensive Community MH Services for Children - Caregivers No Health Public Health Monitoring
Caregiver-Instruments Caregiver-Instruments Yes Yes Fillable Printable Form and instruction Caregiver--Instruments.pdf
State, Local, and Tribal Governments 67039 21397 0

The Nat'l Eval. of theComprehensive Community MH Services for Children - Youth No Health Public Health Monitoring
Youth-Instruments Youth-Instruments Yes Yes Fillable Printable Form and instruction Youth--Instruments.pdf
State, Local, and Tribal Governments 31091 6088 0

The Nat'l Eval. of theComprehensive Community MH Services for Children - Providers/Administrators No Health Public Health Monitoring
Provider Administrator-Instruments Provider Administrator-Instruments Yes Yes Paper Only Form and instruction Provider Administrator--Instruments.pdf
State, Local, and Tribal Governments 134452 12539 0

2012-09-27-04:00

0930-0313 201306-0930-002 0930
             
        "Registration for Behavioral Health Web Site and Resources"
             
          
        
SAMHSA is integrating the National Clearinghouse for Alcohol and Drug Information (NCADI) and the National Mental Health Information Center (NMHIC) into one online resource for behavioral health information. When a member of the public chooses to order hard-copy publications from SAMHSA, it will be necessary for the Agency to collect certain customer information in order to fulfill the request. 2016-08-31-04:00 Active Summer King 2402761243 No No No 59743 1645 0

Web Site Registration No Health Public Health Monitoring
Screenshot of first web registration form Screenshot of first web registration form Yes Yes Fillable Printable Form and instruction Screenshot of first web registration form.jpg Screenshot of second web registration form Screenshot of second web registration form Yes Yes Fillable Printable Form and instruction Screenshot of second web registration form.jpg
State, Local, and Tribal Governments 38605 1286 0

Email Update Subscriptions No Health Public Health Monitoring
Screenshot of SAMHSA's email subscription web form Screenshot of SAMHSA's email subscription web form Yes Yes Fillable Printable Form and instruction Screenshot of SAMHSA's email subscription web form.jpg
State, Local, and Tribal Governments 21138 359 0

2013-08-02-04:00

0930-0316 201209-0930-001 0930
             
        "Survey of State Underage Drinking Prevention Policies and Practices"
             
          
        
The purpose of the data collection through the State Survey will be to create a compendium of the States' best practices and performances in enacting, enforcing, and creating laws, regulations, and programs to prevent or reduce underage drinking. Congress mandated the collection of these data to provide policymakers and the public with currently unavailable but much-needed information regarding State underage drinking prevention policies and programs. 2016-02-29-05:00 Active Summer King 2402761243 No No No 51 903 0

State Survey No Health Public Health Monitoring
State Survey State Survey Yes Yes Fillable Fileable Form and instruction Attachment 3- 2013 STOP Act Survey with OMB edits 02 08 13.docx State Survey State Survey Yes Yes Fillable Printable Form and instruction
State, Local, and Tribal Governments 51 903 0

2013-02-14-05:00

0930-0320 201012-0930-002 0930
             
        "Cross-Site Evaluation for the Benefit of Homeless Individuals (GBHI)"
             
          
        
The information collected through all three surveys (Baseline and 6-month Followup, and Stakeholder Survey) will provide the data necessary to conduct a complete structure, process, outcome, and cost evaluation. The data collected through the Stakeholder Survey will provide descriptive information about stakeholders involved with the CSAT GBHI grant program and their relationship with the grantee program. 2014-03-31-04:00 Active Summer King 2402761243 No No No 11241 4006 0

Baseline No Health Public Health Monitoring
Client Interview_Baseline Client Interview_Baseline Yes Yes Paper Only Form 2 Attachment 2_Client Interview_Baseline_3.3.11.doc
State, Local, and Tribal Governments 5885 1942 0

6 month Followup No Health Public Health Monitoring
Client Interview_6Month Client Interview_6Month Yes Yes Paper Only Form 3 Attachment 3_Client Interview_6Month.3.3.11.doc
State, Local, and Tribal Governments 4708 1883 0

Stakeholder Survey No Health Public Health Monitoring
Privacy Pledge Privacy Pledge Yes Yes Paper Only Form 4 Attachment 4_Stakeholder Survey.doc
State, Local, and Tribal Governments 648 181 0

2011-03-16-04:00

0930-0322 201101-0930-002 0930
             
        "The SOAR Evaluation"
             
          
        
This data collection is an evaluation of the Supplemental Security Income (SSI)/Social Security Disability Income (SSDI) Outreach Access and Recovery (SOAR) initiative. The SSI and SSDI programs provide cash assistance to individuals with qualifying disabilities. Individuals apply to receive benefits and eligibility is contingent on having a medical condition that meets SSA's definition of disability. SOAR aims to increase access to these programs among people who are homeless and thereby improve their quality of life. 2014-04-30-04:00 Active Summer King 2402761243 No No No 10856 1918 0

Focus Groups No Health Public Health Monitoring
Focus groups-instruments Focus groups-instruments Yes Yes Paper Only Form and instruction Focus Groups-Instruments.pdf Focus groups-instruments Focus groups-instruments Yes Yes Paper Only Form and instruction
State, Local, and Tribal Governments 328 272 0

In-Person Interviews No Health Public Health Monitoring
In-person training material-instruments In-person training material-instruments Yes Yes Paper Only Form and instruction In Person Training Material-Instruments.pdf Interviews and survey-instruments Interviews and survey-instruments Yes Yes Paper Only Form and instruction Interviews and Survey Instruments.pdf
State, Local, and Tribal Governments 360 61 0

Web-Based No Health Public Health Monitoring
Web-based training material-instruments Web-based training material-instruments Yes Yes Paper Only Form and instruction Web Based Training Materials-Instruments.pdf
State, Local, and Tribal Governments 10168 1585 0

2011-04-08-04:00

0930-0325 201103-0930-004 0930
             
        "Disaster Technical Assistance Center Disaster Mental Health Needs Assessment and Customer Satisfaction Survey"
             
          
        
The National Response Framework (NRF), establishes the framework for a comprehensive, national, "all-hazards" approach to domestic incident response. The NRF outlines how communities, States, the Federal Government, and private-sector and nongovernmental partners will work together in a coordinated fashion to plan for and develop comprehensive response plans for all types of emergency events. This data collection efforts will provide feedback on the overall effectiveness of SAMHSA Disaster Technical Assistance Center's (DTAC) services, ongoing needs at the national level, and areas that require enhanced Technical Assistance (TA) services. 2014-06-30-04:00 Active Summer King 2402761243 No No No 677 253 0

TA Requestor No Health Health Care Services
Cust Sat Survey Cust Sat Survey Yes Yes Paper Only Form and instruction DTAC Cust Sat Questionnaire_060611_FINAL.doc
State, Local, and Tribal Governments 250 63 0

DBHNA (Local Provider) No Health Health Care Services
Local Provider Version DBHNAS Local Provider Version DBHNAS Yes Yes Paper Only Form and instruction DTAC_LPDBHNAS_060611_FINAL.doc
State, Local, and Tribal Governments 100 50 0

DBHNA (State/Territory) No Health Health Care Services
State/Territory DBHNAS State/Territory DBHNAS Yes Yes Paper Only Form and instruction DTAC_STDBHNAS_060611_FINAL.doc
State, Local, and Tribal Governments 77 77 0

e-Communications Recipient No Health Health Care Services
Cust Sat Survey Cust Sat Survey Yes Yes Paper Only Form and instruction DTAC Cust Sat Questionnaire_060611_FINAL.doc
State, Local, and Tribal Governments 250 63 0

2011-06-06-04:00

0930-0328 201107-0930-001 0930
             
        "Addiction Technology Transfer Centers (ATTC) National Workforce Surveys"
             
          
        
The ATTC Network, a nationwide, multidisciplinary resource that draws upon the knowledge, experience and latest research of recognized experts in the field of addictions, is a SAMHSA/CSAT initiative formed in 1993 in response to a shortage of well-trained addiction and behavioral health professionals in the public sector. The ATTC Network works to enhance the knowledge, skills and aptitudes of the addiction/co-occurring and recovery services workforce by disseminating current health services research from the National Institute on Drug Abuse, National Institute on Alcohol Abuse and Alcoholism, National Institute of Mental Health, Agency for Health Care Policy and Research, National Institute of Justice, and other sources, as well as other SAMHSA programs. To accomplish this, the ATTC Network (1) develops and updates state-of-the-art research based curricula and professional development training, (2) coordinates and facilitates meetings between Single State Authorities, Provider Associations and other key stakeholders, and (3) provides ongoing technical assistance to individuals and organizations at the local, regional and national levels. 2014-09-30-04:00 Active Summer King 2402761243 No No No 619 595 0

Clinical Directors/Supervisors Web-based Survey No Health Health Care Services
Yes No Printable Only Instruction Attachment 2.doc Clinical Director Survey Clinical Director Survey Revised Yes Yes Paper Only Form and instruction Attachment 1.doc Clinical Director Survey Clinical Director Survey Yes Yes Paper Only Form and instruction Attachment 1.doc
State, Local, and Tribal Governments 569 569 0

Clinical Directors/Supervisors Tele Interviews No Health Health Care Services
Key Informant Tele Inter Questionnaire Key Informant Tele Inter Questionnaire Yes Yes Paper Only Form and instruction Attachment 3.doc
State, Local, and Tribal Governments 25 13 0

Thought Leaders Tele Interviews No Health Health Care Services
Key Informant Tele Inter Questionnaire Key Informant Tele Inter Questionnaire Yes Yes Paper Only Form and instruction Attachment 3.doc
State, Local, and Tribal Governments 25 13 0

2011-09-05-04:00

0930-0329 201108-0930-003 0930
             
        "SAMHSA SOAR Web-Based Data Form "
             
          
        
SOAR Web-Based Data Form will collect information from case managers to be used to maintain records on Social Security disability benefits applications, as part of the Supplemental Security Income (SSI)/Social Security Disability Insurance (SSDI) Outreach Access and Recovery (SOAR) effort. 2014-10-31-04:00 Active Summer King 2402761243 No No No 28800 7200 0

SOAR Data Form No Health Illness Prevention
SOAR Data Form SOAR Data Form Yes Yes Paper Only Form and instruction Attachment A.docx
State, Local, and Tribal Governments 28800 7200 0

2011-10-04-04:00

0930-0330 201108-0930-002 0930
             
        "Children Affected by Methamphetamine in Family Drug Treatment Court "
             
          
        
The proposed data collection and analysis for the grantees, referred to as the Children Affected by Methamphetamine in Family Treatment Drug Court (CAM-FTDC) project, will provide knowledge about the services needed and provided to these and similar families. This data collection by the CAM-FTDC program is SAMHSA's first Federal data collection effort focused specifically on the needs of children whose parents have a substance use disorder and are participating in an FTDC, and on effective strategies to address their needs. 2014-10-31-04:00 Active Summer King 2402761243 No No No 1932 966 0

CAM Data Form No Health Illness Prevention
CAM Data Collection Form CAM Data Collection Form Yes Yes Paper Only Form and instruction Attachment_A_CAM_COLLECTION FORM[1].pdf
State, Local, and Tribal Governments 966 483 0

North Carolina Family Assessment Form No Health Illness Prevention
North Carolina Family Assessment Form North Carolina Family Assessment Form Yes Yes Paper Only Form and instruction Attachment B-NCFASGR[1].pdf
State, Local, and Tribal Governments 966 483 0

2011-10-21-04:00

0930-0331 201108-0930-001 0930
             
        "Assessment of the Underage Drinking Prevention Education Initiatives State/Territory Videos Project"
             
          
        
SAMHSA/CSAP intends to support the production of the State/Territory UAD prevention videos annually. The information collected will be used by SAMHSA/CSAP to 1) ascertain whether the videos produced under the State/Territory Videos project are assisting States and Territories in communicating effectively about their UAD prevention initiatives, goals, and objectives; 2) document the dissemination efforts of the videos; and 3) enhance the TA that is provided by the video production team in producing the videos. 2014-10-31-04:00 Active Summer King 2402761243 No No No 3128 268 0

Interview Form No Health Illness Prevention
Interview Form Interview form Yes Yes Paper Only Form and instruction Attachment 1_State Video Contacts Feedback Form_102611.doc
State, Local, and Tribal Governments 15 5 0

Dissemination Update Form No Health Illness Prevention
Dissemination Update Form Dissemination Update Form Yes No Paper Only Form and instruction Attachment 2_Dissemination Update Form_102611.doc
State, Local, and Tribal Governments 57 9 0

Viewers Feedback Form No Health Illness Prevention
Attachment 3 Video Viewers Feedback Form Yes Yes Paper Only Form and instruction Attachment 3_Video Viewers Feedback Form.doc
State, Local, and Tribal Governments 3056 254 0

2011-10-30-04:00

0930-0332 201109-0930-001 0930
             
        "Triennial Evaluation of the Projects for Assistance in Transition from Homelessness (PATH)"
             
          
        
The data collection will focus on the perceptions of key PATH stakeholders at the State and local levels related to PATH operations, services, and effectiveness. This knowledge can help further improve PATH program operations. 2014-12-31-05:00 Active Summer King 2402761243 No No No 150 205 0

State PATH Contact No Health Illness Prevention
Site Visit Interview Guide Site Visit Interview Guide Yes Yes Paper Only Form and instruction Attachment_A_PATH_Site_Visit_Interview_Guide_State_PATH_Contact[1].docx
State, Local, and Tribal Governments 10 11 0

Provider Staff Supervisior/Admin. No Health Illness Prevention
Provider Site Visit Interview Guide Provider Site Visit Interview Guide Yes Yes Paper Only Form and instruction Attachment_B_PATH_Provider_Site_Visit_Interview_Guide_Supervisor_Administrator[1].docx
State, Local, and Tribal Governments 10 7 0

Provider Staff-Worker/Case Manager No Health Illness Prevention
Provider Site Visit Interview Guide Provider Site Visit Interview Guide Yes Yes Paper Only Form and instruction Attachment_C_PATH_Provider_Site_Visit_Interview_Guide_Outreach_Worker_Case_Manager[1].docx
State, Local, and Tribal Governments 10 7 0

Consumer Focus Group Discussion No Health Illness Prevention
Consumer Focus Group Discussion Guide Consumber Focus Group Discussion Guide Yes Yes Paper Only Form and instruction Attachment_D_PATH_Consumer_Focus_Group_Discussion_Guide[1].docx
State, Local, and Tribal Governments 120 180 0

2011-12-11-05:00

0930-0333 201110-0930-001 0930
             
        "Networking Suicide Prevention Hotlines -  Evaluation of the Lifeline Policies for Helping Callers at Immient Risk"
             
          
        
The Evaluation of the Lifeline Policies for Helping Callers at Imminent Risk will collect data, using an imminent risk form, to inform the network's knowledge of the extent to which counselors are aware of and being guided by the Lifeline's imminent risk guidelines; counselors' definitions of imminent risk; the rates of active rescue of imminent risk callers; types of rescue; barriers to intervention; and the circumstances in which active rescue is initiated, including the caller's agreement to receive the intervention. 2015-01-31-05:00 Active Summer King 2402761243 No No No 720 180 0

National Suicide Prevention Lifeline Imminent Risk Form No Health Illness Prevention
Imminent Risk Form Imminent Risk Form Yes Yes Paper Only Form and instruction Attachment A. Imminent Risk Form_1.24.12 final.doc
State, Local, and Tribal Governments 720 180 0

2012-01-24-05:00

0930-0334 201305-0930-002 0930
             
        "Field Test for the 2013 National Survey on Drug Use and Health (NSDUH)"
             
          
        
SAMHSA's Center for Behavioral Health Statistics and Quality (CBHSQ) must update the NSDUH periodically to reflect changing substance abuse and mental health issues. CBHSQ is planning to redesign the NSDUH for the 2015 survey year. The redesign will seek to achieve two main goals: 1) to revise the questionnaire to address changing policy and research data needs, and 2) to modify the survey methodology to improve the quality of estimates and the efficiency of data collection and processing. SAMHSA is requesting approval to conduct a Questionnaire Field Test (QFT) to test revisions to the questionnaire associated with these goals. 2016-07-31-04:00 Active Summer King 2402761243 No No No 6073 2332 0

Household Screening No Health Illness Prevention Individuals or Households 3673 305 0

Interview No Health Illness Prevention
Attachment A questionnaire Attachment A questionnaire Yes Yes Fillable Printable Form and instruction PDF 2 - Attachment A questionnaire.pdf
Individuals or Households 2000 2000 0

Screening Verification No Health Illness Prevention Individuals or Households 100 7 0

Interview Verification No Health Illness Prevention Individuals or Households 300 20 0

2013-07-23-04:00

0930-0335 201210-0930-001 0930
             
        "Treatment Episode Data Set (TEDS)"
             
          
        
TEDS includes admissions to all drug abuse and alcoholism treatment facilities in the United States, the District of Columbia, and Puerto Rico that receive public funds through the State substance abuse agencies or are monitored for administrative purposes through those agencies. Because TEDS is a compilation of data from the State administrative systems, the scope of facilities included in TEDS is affected by differences in State licensure and accreditation practices and disbursement of public funds. 2016-01-31-05:00 Active Summer King 2402761243 No No No 421 3066 0

Admission and Discharge Data Elements No Health Health Care Services State, Local, and Tribal Governments 416 3016 0

Crosswalk No Health Health Care Services State, Local, and Tribal Governments 5 50 0

2013-01-07-05:00

0930-0336 201212-0930-002 0930
             
        "Site Visits With Grantees Integrated HIV Primary Care, Sustance Abuse, and Behavioral Health Services"
             
          
        
The goals of the MAI-TCE project are to facilitate the development and expansion of culturally competent and effective integrated behavioral health and primary care, which include HIV services and medical treatment within 11 of the 12 Metropolitan Statistical Areas (MSAs) and Metropolitan Divisions (MDs) most heavily impacted by HIV/AIDS. The program also supports the integration of behavioral health services (i.e., prevention, treatment, and substance abuse) into the CDC's Enhanced Comprehensive HIV Prevention Plans (ECHPP). Interviews conducted with MAI-TCE grantees during site visits are an integral part of efforts to evaluate: (1) the effectiveness of program implementation across the grantee sites; (2) grantee efforts to integrate behavioral health, substance abuse and HIV care; (3) the variety of program models in use across the grantee sites; and, (4) grantee efforts to engage and successfully reach their target populations. 2016-06-30-04:00 Active Summer King 2402761243 No No No 110 156 0

Interview Guide No Health Illness Prevention
Site Visits Year One Site Visit Interview Guide Site Visits Year One Site Visit Interview Guide Yes Yes Fillable Printable Form and instruction Attachment A-Site Visits Year One Site Visit Interview Guide 12 4 12 Final.docx
State, Local, and Tribal Governments 55 138 0

Assessment Form No Health Illness Prevention
Site Visits Year One Site Visit Form Site Visits Year One Site Visit Form No No Fillable Printable Form and instruction Attachment A-Site Visits Year One Site Visit Interview Guide 12 4 12 Final.docx
State, Local, and Tribal Governments 55 18 0

2013-06-20-04:00

0930-0337 201303-0930-003 0930
             
        "Evaluation of Emergency Department Crisis Center Follow-up"
             
          
        
The overall aim of the project will be to determine the extent to which this collaboration between crisis centers and hospital emergency departments impacts readmission rates for suicidal behavior. This information will be used to advance the field of crisis center support to persons in crisis and inform future directions of the Lifeline. 2016-09-30-04:00 Active Summer King 2402761243 No No No 1000 40 0

Hospital Data Abstraction Form No Health Health Care Services
Hospital Data Abstraction Form Hospital Data Abstraction Form Yes Yes Fillable Printable Form and instruction Attachment A_Hospital Data Abstraction Form.docx
State, Local, and Tribal Governments 667 27 0

Crisis Center Data Abstraction Form No Health Health Care Services
Crisis Center Data Abstraction Form Crisis Center Data Abstraction Form Yes Yes Fillable Printable Form and instruction Attachment B_Elements for Crisis Center Data Extraction rev.doc
State, Local, and Tribal Governments 333 13 0

2013-09-11-04:00

0930-0338 201311-0930-003 0930
             
        "SAMHSA Disaster Technical Assistance Center Training, Webinar, Podcast, and Mobile Application Feedback Forms"
             
          
        
SAMHSA DTAC provides training, webinars, and podcasts in response to, and in preparation for, behavioral health (mental health and substance abuse) needs associated with catastrophic events and emergencies, such as natural disasters, human caused disasters, and technological disasters. These trainings, webinars, and podcasts (TWPs) cover various topics of interest to the disaster behavioral health fields, such as responding to specific types of disasters, working with specific groups of the population to prepare for or respond to disasters, and general disaster behavioral health challenges. 2017-01-31-05:00 Active Summer King 2402761243 No No No 5145 1373 0

Training Feedback Form No Health Illness Prevention
Training Form Training Form Yes Yes Fillable Printable Form and instruction NB Attachment A1 Training Form 7.25.2013.docx
State, Local, and Tribal Governments 1500 375 0

Webinar Podcast Feedback Form No Health Illness Prevention
Webinar Podcast Form Webinar Podcast Form Yes Yes Fillable Printable Form and instruction NB Attachment A2 Webinar Podcast Form 7.25.2013.docx
State, Local, and Tribal Governments 2700 675 0

Mobile Application Survey No Health Illness Prevention
Mobile App Form Mobile App Form Yes Yes Fillable Printable Form and instruction NB Attachment A3 Mobile App Form 7.25.2013.docx
State, Local, and Tribal Governments 600 150 0

Training Feedback Form Follow-up Interviews No Health Illness Prevention
Training Follow-Up Interview Training Follow-Up Interview Yes Yes Fillable Printable Form and instruction NB Attachment B1 Training Follow-Up Interview 7.25.2013.docx
State, Local, and Tribal Governments 150 75 0

Webinar Feedback Form Follow-up Interviews No Health Illness Prevention
Webinar Follow-Up Interview Webinar Follow-Up Interview Yes Yes Fillable Printable Form and instruction NB Attachment B2 Webinar Follow-Up Interview 7.25.2013.docx
State, Local, and Tribal Governments 195 98 0

2014-01-08-05:00

0930-0339 201308-0930-002 0930
             
        "Evaluation of Programs to Provide Services to Persons Who Are Homeless with Mental and /or Substance Use Disorders"
             
          
        
The Homeless Programs cross-program evaluation broadly aims to identify commonalities across the Homeless Programs service delivery by examining which service models are delivered, with what outcomes, for which populations, and with what resulting comparative effectiveness and cost effectiveness. To compare programs, the evaluation will identify service models based on service approach (e.g., direct vs. referral), services (type of service and adherence to practice), housing types and models, type of partnerships and factors leading to program sustainability. The resulting models will facilitate interpretation of client and program-level outcomes, comparative effectiveness and cost-effectiveness evaluation. 2017-01-31-05:00 Active Summer King 2402761243 No No No 1942 2835 0

Project Director - Telephone Follow-up No Health Health Care Services
PD Interview PD Interview Yes Yes Fillable Printable Form and instruction Attachment 01_PD Interview.docx
State, Local, and Tribal Governments 158 332 0

Opening Session/Project Director No Health Health Care Services
Discussion Guide_Cost Questionnaire Discussion Guide_Cost Questionnaire Yes Yes Fillable Printable Form and instruction Attachment 02_SV Discussion Guide_Cost Questionnaire.docx
State, Local, and Tribal Governments 250 175 0

Case Manager, Treatment, Housing Staff/provider Interview No Health Health Care Services
Discussion Guide_Cost Questionnaire Discussion Guide_Cost Questionnaire Yes Yes Fillable Printable Form and instruction Attachment 02_SV Discussion Guide_Cost Questionnaire.docx
State, Local, and Tribal Governments 375 750 0

Stakeholder Interview No Health Health Care Services
Discussion Guide_Cost Questionnaire Discussion Guide_Cost Questionnaire Yes Yes Fillable Printable Form and instruction Attachment 02_SV Discussion Guide_Cost Questionnaire.docx
State, Local, and Tribal Governments 175 263 0

Evaluator Interview No Health Health Care Services
Discussion Guide_Cost Questionnaire Discussion Guide_Cost Questionnaire Yes Yes Fillable Printable Form and instruction Attachment 02_SV Discussion Guide_Cost Questionnaire.docx
State, Local, and Tribal Governments 60 60 0

Client Focus Group No Health Health Care Services
Discussion Guide_Cost Questionnaire Discussion Guide_Cost Questionnaire Yes Yes Fillable Printable Form and instruction Attachment 02_SV Discussion Guide_Cost Questionnaire.docx
State, Local, and Tribal Governments 300 450 0

Cost Interview No Health Health Care Services
Discussion Guide_Cost Questionnaire Discussion Guide_Cost Questionnaire Yes Yes Fillable Printable Form and instruction Attachment 02_SV Discussion Guide_Cost Questionnaire.docx
State, Local, and Tribal Governments 60 120 0

EBP Self-Assessment Part 1 No Health Health Care Services
EBP Self-Assessment Part 1 and Part 2 EBP Self-Assessment Part 1 and Part 2 Yes Yes Fillable Printable Form and instruction Attachment 03_EBP Self-Assessment Part 1 and Part 2.docx
State, Local, and Tribal Governments 127 74 0

EBP Self-Assessment Part 2 No Health Health Care Services
EBP Self-Assessment Part 1 and Part 2 EBP Self-Assessment Part 1 and Part 2 Yes Yes Fillable Printable Form and instruction Attachment 03_EBP Self-Assessment Part 1 and Part 2.docx
State, Local, and Tribal Governments 87 44 0

PSH Self-Assessment No Health Health Care Services
PSH Self-Assessment PSH Self-Assessment Yes Yes Fillable Printable Form and instruction Attachment 04_PSH Self-Assessment.docx
State, Local, and Tribal Governments 100 67 0

Project Director Interview No Health Health Care Services
Discussion Guide_Cost Questionnaire Discussion Guide_Cost Questionnaire Yes Yes Fillable Printable Form and instruction Attachment 02_SV Discussion Guide_Cost Questionnaire.docx
State, Local, and Tribal Governments 250 500 0

2014-01-14-05:00

0935-0106 201104-0935-001 0935
             
        "Voluntary Customer Surveys Generic Clearance for the Agency for Healthcare Research and Quality"
             
          
        
Surveys will assess strengths and weaknesses of agency program services including querying individuals using AHRQ paper and electronic products to determine satisfaction with form and content or to assess effects of streamlining efforts. 2014-07-31-04:00 Active Doris Lefkowitz 3014271477 No No No 10900 3383 0 2011-07-20-04:00

0935-0110 201310-0935-001 0935
             
        "2012 and 2013 Medical Expenditure Panel Survey - Insurance Componenet (MEPS-IC)"
             
          
        
Employer-sponsored health insurance is the source of coverage for 78 million current and former workers, plus many of their family members, and is a cornerstone of the U.S. health care system. The Medical Expenditure Panel Survey - Insurance Component (MEPS-IC) measures the extent, cost, and coverage of employer-sponsored health insurance on an annual basis. These statistics are produced at the National, State, and sub-State (metropolitan area) level for private industry. Statistics are also produced for State and Local governments. 2016-11-30-05:00 Active Doris Lefkowitz 3014271477 No Yes No 113429 23150 0

Prescreener Questionnaire No Health Immunization Management
Form #1 Prescreener Questionnaire Yes Yes Fillable Fileable Form and instruction ATTACHMENT A - Prescreener Questionnaire.docx
Private Sector 32675 2941 0

Establishment Questionnaire No Health Immunization Management
Form #2 Establishment Questionnaire Yes Yes Fillable Fileable Form and instruction ATTACHMENT B - Establishment Questionnaire.pdf
Private Sector 28365 10779 0

Plan Questionnaire No Health Immunization Management
Form #3 Plan Questionnaire Yes Yes Fillable Fileable Form and instruction ATTACHMENT C - Plan Questionnaire.pdf
Private Sector 52389 9430 0

2013-11-21-05:00

0935-0118 201209-0935-001 0935
             
        "Medical Expenditure Panel Survey Household Component and Medical Provider Component (MEPS-HC and MEPS-MPC through 2009)"
             
          
        
The MEPS includes the collection of data from household and medical providers to provide nationally representative unbiased estimates of health care use and expenditures for the U.S. civilian noninstitutionalized population. 2015-12-31-05:00 Active Doris Lefkowitz 3014271477 No No No 505956 82822 0

MEPS-HC Core Interview No Health Immunization Management
Form #1 Attachment 1 -- MEPS-HC Section Summary and Changes http://meps.ahrq.gov/mepsweb/survey_comp/survey_questionnaires.jsp Yes Yes Fillable Fileable Form Attachment 1 -- MEPS-HC Section Summary and Changes.docx
Individuals or Households 37733 54084 0

Adult SAQ No Health Immunization Management
Form #1 Attachment 21 -- HC Adult SAQ Yes Yes Paper Only Form and instruction Attachment 21 -- HC Adult SAQ.docx
Individuals or Households 28254 3296 0

Diabetes Care SAQ No Health Immunization Management
Form #1 Attachment 22 -- HC Diabetes SAQ - Proxy Yes Yes Paper Only Form and instruction Attachment 22 -- HC Diabetes SAQ - Proxy.docx Form #2 Attachment 23 -- HC Diabetes SAQ - Self Yes Yes Paper Only Form and instruction Attachment 23 -- HC Diabetes SAQ - Self.docx
Individuals or Households 2345 117 0

Permission Forms for the MEPS-MPC No Health Consumer Health and Safety
Form #4 Pharmacy Form Yes Yes Paper Only Form and instruction Attachment 73 -- HC Permission Form for the MEPS-MPC -- Pharmacy.doc Form #5 Provider Form Yes Yes Paper Only Form and instruction Attachment 74 -- HC Permission Form for the MEPS-MPC -- Provider.doc
Individuals or Households 0 0 0

Home care for health care providers questionnaire No Health Consumer Health and Safety
Form #1 Home care for health care providers questionnaire Yes Yes Fillable Fileable Form and instruction Attachment 27 -- MPC Home Care for Health Care Providers Questionnaire.doc
Private Sector 3023 252 0

Home care for non health care providers questionnaire No Health Consumer Health and Safety
Form #1 Home care for non health care providers questionnaire Yes Yes Fillable Fileable Form and instruction Attachment 28 -- MPC Home Care for Non-health Care Providers Questionnaire.doc
Private Sector 231 19 0

Office based providers questionnaire No Health Immunization Management
Form #1 Office based providers questionnaire Yes Yes Fillable Fileable Form and instruction Attachment 32 -- MPC Office Based Providers Questionnaire.doc
Private Sector 62640 5220 0

Separately billing doctors questionnaire No Health Immunization Management
Form #1 Separately billing doctors questionnaire Yes Yes Fillable Fileable Form and instruction Attachment 36 -- MPC SBD Questionnaire.doc
Private Sector 21600 1080 0

Hospitals questionnaire No Health Immunization Management
Form #1 Hospitals questionnaire No No Fillable Fileable Form and instruction Attachment 40 -- MPC Hospital Questionnaire.doc
Private Sector 32500 2708 0

Institutions (non-hospital) questionnaire No Health Immunization Management
Form #1 Institutions (non-hospital) questionnaire Yes Yes Fillable Fileable Form and instruction Attachment 46 -- MPC Institutions (non-hospital) Questionnaire.doc
Private Sector 150 13 0

Pharmacies questionnaire No Health Immunization Management
Form #1 Pharmacies questionnaire Yes Yes Fillable Fileable Form and instruction Attachment 48 -- MPC Pharmacies Questionnaire.doc
Private Sector 158440 7922 0

Experiences with Cancer SAQ No Health Immunization Management
Form #12 Experiences with Cancer SAQ Yes Yes Paper Only Form and instruction Attachment A - Experiences with Cancer SAQ - English Version.pdf
Individuals or Households 0 0 0

Authorization form for the MEPS-MPC Provider Survey No Health Immunization Management
Form #1 Authorization Form for the MEPS-MPC - Provider Yes Yes Fillable Fileable Form and instruction Attachment 25 -- HC Authorization Form for the MEPS-MPS - Provider.doc
Individuals or Households 75343 3767 0

Authorization form for the MEPS-MPC Pharmacy Survey No Health Immunization Management
Form #1 Authorization form for the MEPS-MPC Pharmacy Survey Yes Yes Fillable Fileable Form and instruction Attachment 24 -- HC Authorization Form for the MEPS-MPC - Pharmacy.doc
Individuals or Households 44916 2246 0

MEPS-HC Validation Interview No Health Immunization Management
Form #1 Validation Interview Form Yes Yes Fillable Fileable Form and instruction Attachment 26 -- HC Validation Interview Form.doc
Individuals or Households 4781 398 0

MPC Contact Guide/Screening Call No Health Immunization Management
Form #1 Home Health Contact Guide for Organizations Yes Yes Fillable Fileable Form and instruction Attachment 29 -- MPC Home Health Contact Guide for Organizations.doc Form #3 SBD Contact Guide Yes Yes Fillable Fileable Form and instruction Attachment 37 -- MPC SBD Contact Guide.doc Form #4 Hospital Contact Guide Yes Yes Fillable Fileable Form and instruction Attachment 41 -- MPC Hospital Contact Guide.doc Form #5 Institution Contact Guide Yes Yes Fillable Fileable Form and instruction Attachment 47 -- MPC Institution Contact Guide.doc Form #6 Pharmacy Contact Guide Yes Yes Fillable Fileable Form and instruction Attachment 49 -- MPC Pharmacy Contact Guide.doc Form #2 Office Based Contact Guide Yes Yes Fillable Fileable Form and instruction Attachment 35 -- MPC Office Based Contact Guide.doc
Private Sector 34000 1700 0

2012-12-20-05:00

0935-0124 201104-0935-002 0935
             
        "Questionnaire and Data Collection Testing, Evaluation, and Research for the Agency for Healthcare Research and Quality"
             
          
        
Work conducted under this clearance is intended to improve AHRQ's current data collections by developing new surveys and revising surveys and to test survey instruments more quickly. 2014-05-31-04:00 Active Doris Lefkowitz 3014271477 No No No 4600 2967 0

Cognitive Testing of the MEPS Cancer SAQ No Health Immunization Management
Form #2 Cognitive Interview Guide Yes Yes Paper Only Form and instruction Attachment C -- Cognitive Interview Guide 4-20-2011.docx Form #1 Screener Questionnaire Yes Yes Paper Only Form and instruction Attachment B -- Screener Questionnaire 5-26-2011.docx
Individuals or Households 160 88 0

Pretest of Proposed CAHPS for Cancer Care Questions and Methodology No Health Immunization Management
Form #1 CAHPS Cancer Care Questionnaires Yes Yes Paper Only Form and instruction Attachment A - CAHPS Cancer Care Questionnaires 11-2-2011.docx
Individuals or Households 1800 600 0

Pretest of the Medical Expenditure Panel Survey No Health Immunization Management
Form #1 Quick Response Survey Questionnaire Yes Yes Fillable Fileable Form Attachment A -- MEPS Quick Response Survey Questionnaire.docx
Individuals or Households 1500 250 0

AHRQ Publicity Center Patient-Centered Outcomes Research Awareness Campaign Health Care Provider Concept Testing No Health Immunization Management
Form #1 Screening Questionnaire Yes Yes Paper Only Form and instruction Attachment A - Screening Questionnaire.docx Form #2 Focus Group Moderator Guide Yes Yes Paper Only Form and instruction Attachment B - Focus Group Moderator Guide.docx
Private Sector 410 162 0

A Survey of Physicians in Solo and Smaller Primary Care Practices No Health Immunization Management
Form #1 Cognitive testing questionnaire Yes Yes Paper Only Form Attachment A - Cognitive testing questionnaire.docx Form #2 Pilot survey questionnaire Yes Yes Paper Only Form Attachment B - Pilot survey questionnaire.docx Form #3 Follow-up interview guide Yes Yes Paper Only Form Attachment C - Follow up interview guide.docx
Private Sector 355 90 0

Pilot Test of an Interview Protocol Designed to Evaluate Emergency Preparedness and Response Capabilities No Health Immunization Management
Form #1 Emergency Preparedness and Response Capabilities Interview Protocol Yes Yes Paper Only Form and instruction Attachment A -- Emergency Prepardness and Response Capabilities Interview Protocol.docx
State, Local, and Tribal Governments 60 60 0

2011-05-27-04:00

0935-0128 201009-0935-001 0935
             
        "Eisenberg Center Voluntary Customer Survey Generic Clearance for the AHRQ "
             
          
        
AHRQ is the lead agency charged with supporting research designed to improve the quality of healthcare, reduce its cost, improve patient safety, decrease medical errors, and broaden access to essential services (see 42 U.S.C. 299). AHRQ's Eisenberg Center is an innovative effort aimed at improving communication of findings to a variety of audiences ("customers"), including consumers, clinicians, and health care policy makers. The Eisenberg Center compiles research results into a variety of useful formats for customer stakeholders. The Eisenberg Center also conducts its own program of research into effective communication of research findings in order to improve the usability and rapid incorporation of findings into medical practice. The Eisenberg Center is one of three components of AHRQ's Effective Health Care Program (see 42 U.S.C. 299b-7). For the period 2005 until September 2008, the Eisenberg Center was operated through a contractual arrangement with the Oregon Health and Science University (OHSU), Department of Medicine, located in Portland, Oregon. In September 2008, the contract for operation of the Eisenberg Center was awarded to Baylor College of Medicine (BCM), located in Houston Texas. 2014-02-28-05:00 Active Doris Lefkowitz 3014271477 No No No 19612 6202 0 2011-02-27-05:00

0935-0143 201206-0935-003 0935
             
        "Patient Safety Organization Certification Forms and Patient Safety Confidentiality Complaint Form"
             
          
        
The Patient Safety and Quality Improvement Act of 2005 was enacted to provide an incentive for health care providers to work to improve patient safety. In order to implement the act, HHS issued the Patient Safety and Quality Improvement Final Rule which establishes a framework by which providers may voluntarily report information to PSOs. In addition, the Patient Safety Rule outlines the requirements that entities must meet to become PSOs and the process by which the Secretary will review and accept certifications and list PSOs. In December 2010, HHS issued Guidance Regarding Patient Safety Organizations' Reporting Obligations and the Patient Safety and Quality Improvement Act of 2005. On June 2nd, 2011 OMB approved Supplemental Attestations Regarding FDA Reporting Obligations Of PSOs, a new form to comply with this new Guidance. With this submission the Attestation Form has been incorporated into the other existing PSO forms. 2014-10-31-04:00 Active Doris Lefkowitz 3014271477 No No No 919 75764 0

Common Formats No Health Consumer Health and Safety
Form #7 Common Formats Complete Set of Forms Yes Yes Fillable Fileable Form and instruction Attachment K -- Common Formats Complete Set of Forms.pdf
Private Sector 750 75000 0

Certification for Continued Listing Form No Health Consumer Health and Safety
Form #2 PSO Certification for Continued Listing Form http://www.pso.ahrq.gov/listing/certconlistfm.htm Yes Yes Fillable Fileable Form and instruction Attachment E -- PSO Certification for Continued Listing.fin.docx
Private Sector 24 192 0

Disclosure Form - Revised No Health Consumer Health and Safety
Form #4 PSO Disclosure Statement Form http://www.pso.ahrq.gov/listing/disclosfm.htm Yes Yes Fillable Fileable Form and instruction Attachment G -- PSO Disclosure Statement.fin.docx
Private Sector 7 21 0

Two Bona Fide Contracts Requirement Form No Health Consumer Health and Safety
Form #3 PSO Two Bona Fide Contracts Requirement Form http://www.pso.ahrq.gov/listing/contractsfm.htm Yes Yes Fillable Fileable Form and instruction Attachment F -- PSO Two Bona Fide Contracts Requirement.fin.docx
Private Sector 40 40 0

Information Form - Revised No Health Consumer Health and Safety
Form #5 PSO Information Form Yes Yes Fillable Fileable Form and instruction Attachment H -- PSO Information Form.docx
Private Sector 80 240 0

Patient Safety Organization Certification for Initial Listing Form No Health Consumer Health and Safety
Form #1 Patient Safety Organization Certification for Initial Listing Form http://www.pso.ahrq.gov/listing/certfm.htm Yes Yes Fillable Fileable Form and instruction Attachment D -- PSO Certification for Initial Listing.fin.docx
Private Sector 15 270 0

Patient Safety Confidentiality Complaint Form No Health Immunization Management
Form #6 Patient Safety Confidentiality Complaint Form Yes Yes Fillable Printable Form and instruction Attachment I -- Patient Safety Confidentiality Complaint Form 02.22.11.pdf
Private Sector 3 1 0

2012-08-05-04:00

0935-0147 201102-0935-004 0935
             
        "AHRQ Healthcare Innovations Exchange Innovator Interview and AHRQ Healthcare Innovations Exchange Innovator Email Submission Guidelines"
             
          
        
The Innovations Exchange will provide a national-level information hub to foster the implementation and adaptation of innovative strategies that improve health care quality and minimize disparities in the care received by different populations. It is intended to address stakeholder interest in a "one-stop shop" that presents digested and reliable information about health care delivery innovations along with their accompanying implementation tools and networking opportunities to share implementation strategies and techniques. Its target audiences, broadly defined, will be current and potential change agents in the U.S. health care system, including clinicians (e.g., physicians, nurses, and other providers), health system administrators, health plan managers, health service purchasers, regulators, and policymakers from relevant Federal and state agencies. 2014-05-31-04:00 Active Doris Lefkowitz 3014271477 No No No 909 581 0

Email submission No Health Consumer Health and Safety
Form #1 Email Submission Guidelines Yes Yes Printable Only Form and instruction Attachment B -- Email Submission Guidelines 0818_10.doc
Private Sector 17 9 0

Health care innovator interview -following email submission No Health Consumer Health and Safety
Form #2 Innovator Interview Guide for Email Submissions No No Paper Only Form and instruction Attachment C 2-- Health care innovator interview -following email submission.doc
Private Sector 0 0 0

Health care innovator interview - without email submission No Health Consumer Health and Safety
Form #3 Innovator Interview Guide No No Paper Only Form and instruction Attachment C -- Health care innovator interview - without email submission .doc
Private Sector 0 0 0

Annual follow-up interview No Health Consumer Health and Safety
Form #4 Annual follow-up interview No No Paper Only Form and instruction Attachment D -- Annual Follow-up Guide.doc
Private Sector 0 0 0

Health care innovator interview No Health Consumer Health and Safety
Form #2 Health Care Innovator Interview Guide Yes Yes Paper Only Form and instruction Attachment C -- Innovator Interview Guide 0818_10.doc
Private Sector 167 209 0

Annual follow-up reviews No Health Consumer Health and Safety
Form #3 Annual Follow-up Emails Yes Yes Printable Only Form and instruction Attachment D -- Annual Follow-up Guide.doc
Private Sector 725 363 0

2011-05-25-04:00

0935-0162 201308-0935-001 0935
             
        "Collection of Information for AHRQ's Hospital Survey on Patient Safety Culture Comparative Database"
             
          
        
Background on the Hospital SOPS: In 1999, the Institute of Medicine called for health care organizations to develop a "culture of safety" such that their workforce and processes focus on improving the reliability and safety of care for patients (IOM, 1999; To Err is Human: Building a Safer Health System). To respond to the need for tools to assess patient safety culture in health care, AHRQ developed and pilot tested the Hospital Survey on Patient Safety Culture with OMB approval (OMB NO. 0935-0115; Approved 2/4/2003). The survey was designed to enable hospitals to assess staff opinions about patient safety issues, medical error, and error reporting and includes 42 items that measure 12 dimensions of patient safety culture. AHRQ released the survey in the public domain along with a Survey User's Guide and other toolkit materials in November 2004 on the AHRQ web site. Since its release, the survey has been voluntarily used by hundreds of hospitals in the U.S. Rationale for the information collection: The Hospital SOPS survey and the Hospital SOPS Comparative Database are supported by AHRQ to meet its goals of promoting improvements in the quality and safety of health care in hospital settings. The surveys, toolkit materials, and comparative database results are all made available in the public domain along with technical assistance, provided by AHRQ through its contractor at no charge to hospitals, to facilitate the use of these materials for hospital patient safety and quality improvement. 2016-09-30-04:00 Active Doris Lefkowitz 3014271477 No No No 1520 1793 0

Eligibility/Registration Form and Data Submission No Health Consumer Health and Safety
Form #1 Eligibility and Registration Form Yes Yes Fillable Fileable Form and instruction Attachment G -- Eligibility and Registration Form.doc
Private Sector 304 1702 0

Data Use Agreement No Health Consumer Health and Safety
Form #2 Data Use Agreement Yes Yes Printable Only Form and instruction Attachment F -- Data Use Agreement.docx
Private Sector 304 15 0

Patient Safety Improvement Initiatives Form No Health Consumer Health and Safety
Form #3 Patient Safety Improvement Initiatives Form Yes Yes Fillable Fileable Form and instruction Attachment A-9 -- Patient Safety Improvement Initiatives Form.doc
Private Sector 0 0 0

Hospital Information Form No Health Consumer Health and Safety
Form #3 Hospital Information Form Yes Yes Fillable Fileable Form and instruction Attachment H -- Hospital Information Form.doc
Private Sector 912 76 0

2013-09-26-04:00

0935-0179 201104-0935-006 0935
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery"
             
          
        
This collection of information is necessary to enable the Agency to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the Agency's programs. 2014-07-31-04:00 Active Doris Lefkowitz 3014271477 No No No 10900 3383 0

Customer Satisfaction with AHRQ's Health IT Literacy Guide No Health Immunization Management
Form #1 Focus Group Moderator Guide Yes Yes Paper Only Form and instruction Attachment A - Focus Group Moderator Guide 091311.docx Form #2 Screening Instrument for Focus Groups Yes Yes Paper Only Form and instruction Attachment C - Screening Instrument for Focus Groups 091311.docx
Private Sector 126 106 0

AHRQ Publicity Center Patient-Centered Outcomes Research Awareness Campaign Concept Testing No Health Immunization Management
Form #1 Screening Questionnaire Yes Yes Fillable Fileable Form and instruction Attachment A -- Screening Questionnaire.docx Form #2 Focus Group Moderator Guide No Yes Paper Only Form and instruction Attachment B -- Focus Group Moderator Guide.docx
Individuals or Households 392 135 0

Customer Satisfaction with AHRQ's Research Activities Newsletter No Health Immunization Management
Form #1 Research Activities Newsletter Questionnaire Yes Yes Fillable Fileable Form Attachment A -- Research Activities Newsletter Questionnaire.docx
Individuals or Households 3000 50 0

Customer Satisfaction with HIE Evaluation Toolkit No Health Immunization Management
Form #1 Screening Questionnaire Yes Yes Fillable Fileable Form and instruction Attachment E - Screening Questionnaire.docx Form #3 Monthly Check-in Phone Follow-up Yes Yes Fillable Fileable Form and instruction Attachment B - Monthly Check-in Phone Follow-up.docx Form #2 Monthly E-mail Check-in Text Yes Yes Fillable Fileable Form and instruction Attachment A - Monthly Email Check-in Text.docx Form #4 In-depth Interview Guide Yes Yes Fillable Fileable Form and instruction Attachment C - In-depth Interview Guide.docx
Private Sector 120 34 0

Customer Satisfaction with AHRQ's Quality Measurement Initiatives No Health Immunization Management
Form #1 MONAHRQ Host User Group Questionnaire Yes Yes Fillable Fileable Form and instruction Attachment A -- MONAHRQ Host User Group Questionnaire.doc Form #2 HCUP Partners Software Redesign Questionnaire Yes Yes Fillable Fileable Form and instruction Attachment B -- HCUP Partners Software Redesign Questionnaire.doc
Private Sector 100 25 0

Customer Satisfaction with the 2012 Guide to Clinical Preventive Services No Health Immunization Management
Form #1 Guide to Clinical Preventive Services Feedback Questionnaire Yes Yes Fillable Fileable Form Attachment A -- Guide to Clinical Preventive Services Feedback Questionnaire BC.docx
Private Sector 5000 167 0

Customer Satisfaction with the AHRQ Quality Indicators (QI) and QI Software, Documentation and User Support No Health Immunization Management
Form #2 Adoption and Use of AHRQ QI Questionnaire Yes Yes Fillable Fileable Form Attachment B -- Adoption and Use of AHRQ QI Questionnaire.docx Form #1 AHRQ QI Software and Documentation Questionnaire Yes Yes Fillable Fileable Form Attachment A -- AHRQ QI Software and Documentation Questionnaire.docx
Private Sector 1718 143 0

Customer Satisfaction with the AHRQ Videonovela Aprende a vivir. No Health Immunization Management
Form #1 Attachment A -- Patient Questionnaire - Spanish Version Yes Yes Paper Only Form and instruction Attachment A -- Patient Questionnaire -- Spanish Version.docx Form #2 Attachment C - Health Care Professional Questionnaire Yes Yes Paper Only Form and instruction Attachment C -- Healthcare Professional Questionnaire.docx
Private Sector 210 35 0

Customer Satisfaction with AHRQ's Patient-Centered Outcomes Research (PCOR) Educational Materials No Health Consumer Health and Safety
Form #1 Web-based Survey Yes Yes Fillable Fileable Form Attachment A -- Web-based Survey.docx Form #2 Screening Questionnaire Yes Yes Paper Only Form Attachment B -- Screening Questionnaire.doc Form #4 Pre-Focus Group Questionnaire - Group2 Yes Yes Paper Only Form Attachment C2 -- Pre-Focus Group Questionnaire Group2.doc Form #5 Focus Group Moderator Guide - Group1 Yes Yes Paper Only Form Attachment D1 -- Focus Group Moderator Guide Group1.doc Form #6 Focus Group Moderator Guide - Group2 Yes Yes Paper Only Form Attachment D2 -- Focus Group Moderator Guide Group2.doc Form #3 Pre-Focus Group Questionnaire - Group1 Yes Yes Paper Only Form Attachment C1 -- Pre-Focus Group Questionnaire Group1.doc
Private Sector 1440 237 0

2011-07-24-04:00

0935-0181 201106-0935-001 0935
             
        "Comparative Effectiveness Research - Continuing Education"
             
          
        
This project is part of a larger three-year effort involving five complementary but separate projects. Four projects will focus on different audiences and methods for dissemination of health care related information to create awareness of comparative effectiveness research and changing clinician behavior, and the fifth will evaluate the impact of those four projects. The fifth project will collect data from all four dissemination projects to compare and analyze the effectiveness of the four different methods of dissemination. This submission focuses on the delivery of continuing education as Part 1 of the 5-part project. 2014-08-31-04:00 Active Doris Lefkowitz 3014271477 Yes No No 234000 13650 0

AHRQ Online Continuing Education CME/CE/CEU Registration Data No Health Consumer Health and Safety
Form #1 CME Registration Form Yes Yes Paper Only Form and instruction Attachment B -- CME Registration Form.pdf
Individuals or Households 58500 4875 0

AHRQ Online Continuing Education Participant Evaluation No Health Consumer Health and Safety
Form #2 AHRQ Online Continuing Education Participant Evalua Yes Yes Paper Only Form and instruction Attachment C -- AHRQ Online Continuing Education Participant Evaluation 7-25-2011.doc
Individuals or Households 175500 8775 0

2011-08-10-04:00

0935-0183 201106-0935-002 0935
             
        "Pilot Test of the Proposed Pharmacy Survey on Patient Safety Culture"
             
          
        
Given the widespread impact of pharmacies on patient safety, the new Pharmacy Survey on Patient Safety Culture (Pharmacy SOPS) will measure pharmacy staff perceptions about what is important in their organization and what attitudes and behaviors related to patient safety are supported, rewarded, and expected. The survey will help community/retail pharmacies to identify and discuss strengths and weaknesses of patient safety culture within their individual pharmacies. They can then use that knowledge to develop appropriate action plans to improve their practices and their culture of patient safety. This survey is designed for use in community/retail pharmacies, which includes chain drugstores (e.g., Walgreens and CVS), supermarket pharmacies, independently owned pharmacies, and mass merchant pharmacies (e.g., Wal-Mart, Costco, Target), not for use in hospital pharmacies. 2014-08-31-04:00 Active Doris Lefkowitz 3014271477 No No No 707 197 0

Cognitive interviews No Health Immunization Management
Form #1 Cognitive Interview Guide Yes Yes Paper Only Form and instruction Attachment B -- Cogntive Interview Guide 2-8-11.docx
Private Sector 20 30 0

Pretest No Health Immunization Management
Form #2 Draft Pretest Questionnaire Yes Yes Paper Only Form and instruction Attachment C -- Draft Pretest Questionnaire 2-8-11.doc
Private Sector 627 157 0

Pharmacy background questionnaire No Health Immunization Management
Form #3 Draft Pharmacy Background Questionnaire Yes Yes Paper Only Form and instruction Attachment E -- Draft Pharmacy Background Questionnaire 2-8-11.docx
Private Sector 60 10 0

2011-08-12-04:00

0935-0187 201110-0935-002 0935
             
        "Evaluation of the Technical Assistance to ARRA Complex Patient Grantees Project"
             
          
        
In order to support its' R21 and R24 complex patient grantees, AHRQ funded a Learning Network and Technical Assistance Center (LN&TAC) to encourage collaboration among the researchers and help them share research methods, definitions and products through in-person meetings, small workgroups and network facilitation. The LN&TAC will provide the grantees with technical assistance regarding research design, data collection, data analysis, public use dataset development, and dissemination. The purpose of this Information Collection Request is to evaluate the effectiveness of the LN&TAC. 2014-12-31-05:00 Active Doris Lefkowitz 3014271477 Yes No No 96 19 0

LN Meeting Evaluation No Health Immunization Management
Form #1 LN Meeting Evaluation Yes Yes Paper Only Form and instruction Attachment A -- LN Meeting Evaluation.doc
Private Sector 22 7 0

Group TA Evaluation No Health Immunization Management
Form #2 Group TA Evaluation Yes Yes Fillable Fileable Form and instruction Attachment B -- Group TA Evaluation.doc
Private Sector 32 3 0

Individual TA Evaluation No Health Immunization Management
Form #3 Individual TA Evaluation Yes Yes Fillable Fileable Form and instruction Attachment C -- Individual TA Evaluation.doc
Private Sector 15 1 0

Annual Survey No Health Immunization Management
Form #4 Annual Survey Yes Yes Fillable Fileable Form and instruction Attachment D -- Annual Survey.doc
Private Sector 22 4 0

Annual Interview No Health Immunization Management
Form #5 Annual Interview Yes Yes Paper Only Form and instruction Attachment E -- Annual Interview.doc
Private Sector 5 4 0

2011-12-01-05:00

0935-0190 201110-0935-003 0935
             
        "Evaluation of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) Quality Demonstration Grant Program"
             
          
        
Section 401(a) of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Pub. L. 111-3, amended the Social Security Act (the Act) to enact section 1139A (42 U.S.C. 1320b-9a). AHRQ is requesting approval from the Office of Management and Budget (OMB) for data collection to support a national evaluation of the quality demonstration grants authorized under section 1139A(d) of the Act. Evaluating whether the CHIPRA demonstration grants improve the quality of care received by children in Medicaid and CHIP aligns with AHRQ's mission of improving the quality and effectiveness of health care in the United States. 2015-02-28-05:00 Active Doris Lefkowitz 3014271477 Yes No No 837 855 0

Key Staff Interviews No Health Immunization Management
Form #1 Key Staff Interview Guide Yes Yes Paper Only Form and instruction Attachment B_KeyStaff Interview Guide.docx
Private Sector 144 216 0

Implementation Staff Interviews No Health Immunization Management
Form #2 Implementation Satff Interview Guide Yes Yes Printable Only Form and instruction Attachment C_ Implementation Staff Interview Guide.docx
Private Sector 288 288 0

Stakeholder Interviews No Health Immunization Management
Form #3 Stakeholder Interview Guide Yes Yes Paper Only Form and instruction Attachment D_ Stakeholder Interview Guide.docx
Private Sector 144 144 0

Health Care Provider Interviews No Health Immunization Management
Form #4 Health Care Provider Interview Guide Yes Yes Printable Only Form and instruction Attachment E _ Health Care Provider Interview Guide.docx
Private Sector 216 162 0

Non-demonstration States Interviews No Health Immunization Management
Form #5 Other States Interview Guide Yes Yes Paper Only Form and instruction Attachment F_Other States Interview Guide.docx
Private Sector 45 45 0

2012-02-17-05:00

0935-0191 201112-0935-001 0935
             
        "Evaluation of ARRA Comparative Effectiveness Research Dissemination Contractor Efforts"
             
          
        
To augment AHRQ's existing Comparative Effectiveness Research (CER) dissemination efforts performed by the Eisenberg Center and other initiatives, AHRQ is conducting four one-time projects to test other ways to disseminate CER results. These four related projects will test new approaches to CER dissemination and promote awareness of the Effective Healthcare Program (EHCP). Collectively, dissemination efforts will reach AHRQ's priority audiences of: clinical decision makers, health care system decision makers, purchasers/business decision makers, public policy decision makers, and consumers/patients. Through these four projects AHRQ aims to: (1) educate professional and consumer audiences about CER; (2) inform professional and consumer audiences about AHRQ's EHCP; (3) and inform a wide range of audiences about new EHCP research findings. This project will evaluate the effectiveness of these four new dissemination efforts. 2015-03-31-04:00 Active Doris Lefkowitz 3014271477 Yes No No 8760 2450 0

Clinician Survey No Health Immunization Management
Form #1 Clinician Questionnaire Yes Yes Paper Only Form and instruction Attachment A -- Clinician Questionnaire.docx
Private Sector 3852 1284 0

Consumer/Patient Screener No Health Immunization Management
Form #2 Consumer or Patient Screener Questionnaire Yes Yes Fillable Fileable Form and instruction Attachment C -- Consumer or Patient Screener Questionnaire.doc
Individuals or Households 2560 213 0

Consumer/Patient Survey No Health Immunization Management
Form #3 Consumer or Patient Questionnaire Yes Yes Fillable Fileable Form and instruction Attachment D -- Consumer or Patient Questionnaire.doc
Individuals or Households 2000 667 0

Clinician Focus Groups No Health Immunization Management
Form #4 Clinician Focus Group Guide Yes Yes Paper Only Form and instruction Attachment F -- Clinician Focus Group Guide.doc
Private Sector 72 72 0

Consumer/Patient Focus Groups Screener No Health Immunization Management
Form #5 Consumer or Patient Focus Group Screener Questionnaire Yes Yes Paper Only Form and instruction Attachment K -- Consumer or Patient Focus Group Screener Questionnaire.doc
Individuals or Households 120 10 0

Consumer/Patient Focus Groups No Health Immunization Management
Form #8 Consumer or Patient Focus Group Guide -- Unaware of CER Yes Yes Paper Only Form and instruction Attachment J -- Consumer or Patient Focus Group Guide -- Unaware of CER.doc Form #7 Consumer or Patient Focus Group Guide -- Aware without use Yes Yes Paper Only Form and instruction Attachment I -- Consumer or Patient Focus Group Guide -- Aware without Use.doc Form #6 Consumer or Patient Focus Group Guide -- Aware with use Yes Yes Printable Only Form and instruction Attachment H -- Consumer or Patient Focus Group Guide -- Aware With Use.doc
Individuals or Households 96 144 0

Semi-structured Interviews with Health System Decision Makers No Health Immunization Management
#9 Focus Group Moderator Guide for Decision Makers Yes Yes Paper Only Form and instruction Attachment M -- Focus Group Moderator Guide for Decision Makers.doc
Private Sector 20 20 0

Semi-structured Interviews with Purchasers No Health Immunization Management
#10 Focus Group Moderator Guide for Purchasers Yes Yes Paper Only Form and instruction Attachment N -- Focus Group Moderator Guide for Purchasers.doc
Private Sector 20 20 0

Semi-structured Interviews with Policymakers No Health Immunization Management
#11 Focus Group Moderator Guide for Policymakers Yes Yes Paper Only Form and instruction Attachment O -- Focus Group Moderator Guide for Policymakers.doc
Private Sector 20 20 0

2012-03-23-04:00

0935-0192 201202-0935-001 0935
             
        "Assessing the Feasibility of Disseminating Effective Health Care Products through a Shared Electronic Medical Record Serving Member Organizations of a Health Information Exchange"
             
          
        
The collections proposed under this clearance include activities to assess the feasibility of disseminating materials developed by the Eisenberg Center - Baylor College of Medicine through the use of an electronic medical record (EMR) shared by a network of clinical care providers that are part of a Health Information Exchange (HIE) operating in multiple sites in several states. 2014-06-30-04:00 Active Doris Lefkowitz 3014271477 Yes No No 400 133 0

Interviews with Clinicians No Health Consumer Health and Safety
Form #1 Interview Guide for Clinicians Yes Yes Paper Only Form Attachment A -- Interview Guide for Clinicians.docx
Private Sector 50 25 0

Interviews with Support Staff No Health Consumer Health and Safety
Form #2 Interview Guide for Support Staff Yes Yes Paper Only Form Attachment B -- Interview Guide for support Staff.docx
Private Sector 50 25 0

Interviews with Patients No Health Consumer Health and Safety
Form #3 Interview Guide for Patients Yes Yes Paper Only Form Attachment C -- Interview Guide for Patients.docx
Individuals or Households 100 50 0

Survey of Clinicians No Health Consumer Health and Safety
Form #4 Questionnaire for Clinicians Yes Yes Paper Only Form Attachment D -- Questionnaire for Clinicians.docx
Private Sector 200 33 0

2012-06-01-04:00

0935-0193 201202-0935-002 0935
             
        "Assessing the Feasibility of Disseminating Effective Health Center Products through Mobile Phone Applications"
             
          
        
The collections proposed under this clearance include activities to assess the feasibility of using specific media and awareness-raising processes to encourage consumers who are at risk for selected health problems for which AHRQ's Effective Health Care (EHC)Program materials are available to access information about such materials using mobile phone technologies. The project will specifically focus on promoting awareness of eight consumer guides developed through the EHC Program. The guides are all published in English and Spanish-language versions. All of the guides are designed to help decision makers, including clinicians and health care consumers, use research evidence to maximize the benefits of health care, minimize harm, and optimize the use of health care resources. The project will test the feasibility of using mobile telephone technology for the dissemination of EHC Program materials to underserved health consumer populations using: a) short message services (SMS), usually referred to as texting, that can be provided to people with basic cell phone service and texting support; and b) mobile Web access that provides access to the Internet via a mobile interface. 2014-06-30-04:00 Active Doris Lefkowitz 3014271477 Yes No No 766 191 0

Focus Groups with Clinicians No Health Immunization Management
Form #1 Clinician Focus Group Discussion Guide Yes Yes Paper Only Form and instruction Attachment C -- Clinician Focus Group Discussion Guide.docx
Private Sector 30 23 0

Focus Groups with Support Staff No Health Immunization Management
Form #2 Support Staff Focus Group Discussion Guide Yes Yes Paper Only Form and instruction Attachment D -- Support Staff Focus Group Discussion Guide.docx
Private Sector 36 27 0

Patient Interviews No Health Immunization Management
Form #3 Patient Interview Questions Yes Yes Paper Only Form and instruction Attachment E -- Patient Interview Questions.docx
Individuals or Households 300 75 0

Feedback Questionnaire for Patients Requesting Mailed Guides No Health Immunization Management
Form #4 Feedback Questionnaire for Patients Requesting Mailed Guides Yes Yes Paper Only Form Attachment F -- Feedback Questionnaire for Patients Requesting Mailed Guides.docx
Individuals or Households 200 33 0

Feedback Questionnaire for Patients Visiting Mobile Web site No Health Immunization Management
Form #5 Feedback Questionnaire for Patients Visiting the Mobile Web site Yes Yes Fillable Fileable Form Attachment G -- Feedback Questionnaire for Patients Visiting Mobile Web Site.docx
Individuals or Households 200 33 0

2012-06-01-04:00

0935-0194 201202-0935-004 0935
             
        "Assessing the Feasibility of Disseminating Effective Health Center Products through Educational Activities"
             
          
        
The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) approve under the Paperwork Reduction Act of 1995 this collection of information from users of products provided by the John M. Eisenberg Clinical Decisions and Communications Science Center (Eisenberg Center). Information collected consists of feedback from managers, instructors, and learners about these health care guides and other products presented as part of Continuing Medical Education activities. 2014-06-30-04:00 Active Doris Lefkowitz 3014271477 Yes No No 9050 785 0

Interviews with CME Project Directors No Health Consumer Health and Safety
Form #1 Interview guide for CME project directors Yes Yes Paper Only Form Attachment A -- Interview guide for CME project directors.docx
Private Sector 10 5 0

Focus Group with CME Project Directors No Health Consumer Health and Safety
Form #2 Focus group topic guide for CME project directors Yes Yes Paper Only Form Attachment B -- Focus group topic guide for CME project directors.docx
Private Sector 10 15 0

Interviews with Faculty Members No Health Consumer Health and Safety
Form #3 Interview guide for faculty members Yes Yes Paper Only Form Attachment C -- Interview guide for faculty members.docx
Private Sector 30 15 0

Initial Survey Assessment of CME Participants No Health Consumer Health and Safety
Form #4 Initial survey assessment for CME participants Yes Yes Fillable Fileable Form Attachment D -- Initial survey assessment for CME participants.docx
Private Sector 4500 375 0

Follow up Survey Assessment of CME Participants No Health Consumer Health and Safety
Form #5 Follow-up survey assessment for CME participants Yes Yes Fillable Fileable Form Attachment E -- Follow-up survey assessment for CME participants.docx
Private Sector 4500 375 0

2012-06-01-04:00

0935-0195 201202-0935-003 0935
             
        "Nursing Home Survey on Patient Safety Culture Comparative Database"
             
          
        
The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) approve, under the Paperwork Reduction Act of 1995, AHRQ's collection of information for the AHRQ Nursing Home Survey on Patient Safety Culture (Nursing Home SOPS) Comparative Database. The Nursing Home SOPS Comparative Database consists of data from the AHRQ Nursing Home Survey on Patient Safety Culture. Nursing homes in the U.S. are asked to voluntarily submit data from the survey to AHRQ through its contractor, Westat. The Nursing Home SOPS Database is modeled after the Hospital SOPS Database [OMB NO. 0935-0162, approved 05/04/2010] that was originally developed by AHRQ in 2006 in response to requests from hospitals interested in knowing how their patient safety culture survey results compare to those of other hospitals. 2015-06-30-04:00 Active Doris Lefkowitz 3014271477 No No No 680 511 0

Eligibility/Registration Forms No Health Immunization Management
Form #1 Eligibility/Registration Forms Yes Yes Fillable Fileable Form Attachment B - NH Eligibility and Regis Forms.docx
Private Sector 85 4 0

Data Use Agreement No Health Immunization Management
Form #2 Data Use Agreement Yes Yes Paper Only Form and instruction Attachment C - NH SOPS DUA.pdf
Private Sector 85 4 0

Nursing Home Site Information Form No Health Immunization Management
Form #3 Nursing Home Site Information Form Yes Yes Fillable Fileable Form Attachment D - NH Site Information Form.docx
Private Sector 425 35 0

Data Submission No Health Immunization Management
Form #4 NH Welcome and Login Pages Yes Yes Fillable Fileable Form and instruction Attachment J - NH Welcome and Login Pages.docx
Private Sector 85 468 0

2012-06-08-04:00

0935-0196 201202-0935-005 0935
             
        "Medical Office Survey on Patient Safety Culture Comparative Database"
             
          
        
The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) approve, under the Paperwork Reduction Act of 1995, AHRQ's collection of information for the AHRQ Medical Office Survey on Patient Safety Culture (Medical Office SOPS) Comparative Database. The Medical Office SOPS Comparative Database consists of data from the AHRQ Medical Office Survey on Patient Safety Culture. Medical offices in the U.S. are asked to voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The Medical Office SOPS Database is modeled after the Hospital SOPS Database [OMB NO. 0935-0162; approved 05/04/2010] that was originally developed by AHRQ in 2006 in response to requests from hospitals interested in knowing how their patient safety culture survey results compare to those of other hospitals. 2015-06-30-04:00 Active Doris Lefkowitz 3014271477 No No No 1950 816 0

Eligibility Form No Health Immunization Management
Form #1 Medical Office SOPS Database Eligibility Form Yes Yes Fillable Fileable Form Attachment B - MO SOPS Eligibility Form.docx
Private Sector 150 8 0

Data Use Agreement No Health Immunization Management
Form #2 Medical Office SOPS Database Data Use Agreement Yes Yes Paper Only Form and instruction Attachment C - MO SOPS Data Use Agrmt.doc
Private Sector 150 8 0

Medical Office Information Form No Health Immunization Management
Form #3 Medical Office Information Form Yes Yes Fillable Fileable Form Attachment D Medical Office Information Form revised 5-15-2012.docx
Private Sector 1500 125 0

Data Submission No Health Immunization Management
Form #4 Example Screen Shots of Web Site Information Collection Yes Yes Fillable Fileable Form Attachment J - Example Screen Shots Web Site Information Collection.docx
Private Sector 150 675 0

2012-06-08-04:00

0935-0197 201202-0935-006 0935
             
        "Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician and Group Survey Comparative Database"
             
          
        
The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) approve, under the Paperwork Reduction Act of 1995, AHRQ's collection of information for the AHRQ Consumer Assessment of Healthcare Providers and Systems (CAHPS) Database for Clinicians and Groups. The CAHPS Clinician and Group Database (CAHPS CG Database) consists of data from the AHRQ CAHPS Clinician and Group Survey (CAHPS CG Survey). Health systems administrators, medical groups and medical practitioners in the U.S. are asked to voluntarily submit data from the CAHPS CG Survey to AHRQ, through its contractor. 2015-06-30-04:00 Active Doris Lefkowitz 3014271477 No No No 90 246 0

Registration Form No Health Immunization Management
Form #1 Clinician Group Submission System Registration Form Yes Yes Fillable Fileable Form Attachment A -- Clinician Group Submission System Registration Form 5-15-2012.docx
Private Sector 30 3 0

Data Submission No Health Immunization Management
Form #2 Data Submission Secure Web Site and Information Collection Forms Yes Yes Fillable Fileable Form Attachment F -- Data Submission Secure Web Site and Information Collection Forms 5-15-2012.doc
Private Sector 30 213 0

Data Use Agreement No Health Immunization Management
Form #3 Clinician and Group Database Data Use Agreement Yes Yes Paper Only Form Attachment B -- CAHPS Clinician Group Database Data Use Agreement.docx
Private Sector 30 30 0

2012-06-08-04:00

0935-0198 201205-0935-001 0935
             
        "System Redesign for Value in Safety Net Hospitals and Delivery Systems"
             
          
        
This proposed project is a case study of 8 safety net (SN) hospitals. The goals of the project are to: 1) identify the tools and resources needed to facilitate system redesign in SN hospitals and; 2) identify any barriers to adoption of these in SN environments, or any gaps that exist in the available resources. These goals are consistent with The National Strategy for Quality Improvement in Health Care, published by the US Department of Health and Human Services in March 2011, which articulated a need for progress toward three goals: 1) Better Care, 2) Healthy People/Healthy Communities and 3) Affordable Care. SN hospitals and systems are critical to achieving all three. SN hospitals are hospitals and health systems which provide a significant portion of their services to vulnerable, uninsured and Medicare patients. While all hospitals face challenges in improving both quality and operating efficiency, safety net (SN) hospitals face even greater challenges due to growing demand for their services and decreasing funding opportunities. 2015-06-30-04:00 Active Doris Lefkowitz 3014271477 No No No 168 176 0

In-person interviews No Health Immunization Management
Form #1 Interview guide Yes Yes Paper Only Form Attachment A - Interview Guide.doc
Private Sector 160 160 0

Collection of documentation No Health Immunization Management
Form #2 Collection of documentation guide Yes Yes Paper Only Form and instruction Attachment B - Collection of Documentation Guide.doc
Private Sector 8 16 0

2012-06-22-04:00

0935-0199 201203-0935-001 0935
             
        "Use of Deliberative Methods to Enhance Public Engagement in Comparative Effectiveness Research"
             
          
        
Public deliberation is a strategy for engaging lay people in informing decisions when these decisions require consideration of values and ethics in addition to scientific evidence. AHRQ wishes to study the effectiveness of public deliberation, because it offers the opportunity to obtain public input on complex topics in an environment that encourages participants to educate themselves about the topic and discuss it in a thoughtful, respectful manner. Information about the topic is intentionally neutral and respectful of the full range of underlying values and experience with health care issues in the population. This approach is designed to improve upon the sometimes superficial or "top of mind" responses that are often provided by public opinion surveys. AHRQ views public deliberation as a potential source of higher quality public input on issues fundamental to the Agency's mission, such as the best and most effective ways to use comparative effectiveness research, than has heretofore been available. 2014-06-30-04:00 Active Doris Lefkowitz 3014271477 Yes No No 8640 9788 0

Recruitment and Consent Materials No Health Immunization Management
Form #1 Attachment A - Recruitment and Consent Materials 6_18_12 Yes Yes Fillable Fileable Form and instruction Attachment A - Recruitment and Consent Materials_6.18.12.docx
Individuals or Households 1680 420 0

Brief Citizens' Deliberation No Health Immunization Management
Form #2 Brief Citizens' Deliberation Facilitator's Guide Yes Yes Fillable Fileable Form and instruction Attachment D1 - Brief Citizens' Deliberation Facilitator's Guide.docx
Individuals or Households 288 576 0

Online Deliberative Polling No Health Immunization Management
Form #3 Online Deliberative Polling Facilitator's Guide Yes Yes Fillable Fileable Form and instruction Attachment D5 - Online Deliberative Polling Facilitator's Guide.docx
Individuals or Households 288 1440 0

Citizens' Panel No Health Immunization Management
Form #5 Citizens' Panel Facilitator's Guide Yes Yes Fillable Fileable Form and instruction Attachment D4 - Citizens' Panel Facilitator's Guide.docx
Individuals or Households 96 2304 0

Communtiy Deliberation No Health Immunization Management
Form #6 Interrupted Deliberation Facilitator's Guide Yes Yes Fillable Fileable Form and instruction Attachment D2 - Interrupted Deliberation Facilitator's Guide.docx
Individuals or Households 288 1728 0

Educational Materials No Health Immunization Management
Form #7 Educational Materials Yes Yes Fillable Fileable Form and instruction Attachment B - Educational Materials.pdf
Individuals or Households 1680 1680 0

Knowledge and Attitudes Pretest Survey No Health Immunization Management
Form #8 Knowledge and Attitudes Pre-test Survey Yes Yes Fillable Fileable Form and instruction Attachment C - Knowledge and Attitudes Survey PreTest.docx
Individuals or Households 1680 840 0

Knowledge and Attitudes Post-test Survey No Health Immunization Management
Form #9 Knowledge and Attitudes Post-test Survey Yes Yes Fillable Fileable Form and instruction Attachment E - Knowledge_and_Attitudes_Survey_PostTest.pdf
Individuals or Households 1680 560 0

Deliberative Experience Survey No Health Immunization Management
Form #10 Deliberative Experience Survey Yes Yes Fillable Fileable Form and instruction Attachment F - Deliberative Experience Survey.pdf
Individuals or Households 960 240 0

2012-06-22-04:00

0935-0200 201206-0935-002 0935
             
        "Synthesis of AHRQ-Funded HAI Projects "
             
          
        
Between 2007 and 2010, AHRQ funded 40 contracts and 18 grants focusing on expanding the HAI knowledge base and implementing HAI prevention strategies. Today it is necessary to look across these projects in order to (1) identify, document, and synthesize their findings and results to ensure that AHRQ, healthcare professionals, and the public can make best use of these findings and (2) identify remaining gaps in the HAI science base to enable AHRQ to fund future studies that will address these needs. The synthesis will draw on several data sources, including interviews with project leaders. In addition to learning about studies that have not published peer-reviewed manuscripts, the interviews will enable the project team to delve into project details that are not typically available in publications, such as the project leader's motivation for responding to the request for proposal, challenges faced in implementing the project, changes in the project's delivery schedule or work plan, experts' views on how HAI prevention evidence generated by a specific project fits into the HAI research agenda more broadly, and remaining gaps in the HAI knowledge base. 2015-09-30-04:00 Active Doris Lefkowitz 3014271477 No No No 58 87 0

Interviews with contractors No Health Immunization Management
Form #1 Interview Guide for Contractors Yes Yes Paper Only Form and instruction Attachment A_Interview_Guide_Contractors.docx
Private Sector 40 60 0

Interviews with grantees No Health Immunization Management
Form #2 Interview Guide for Grantees Yes Yes Paper Only Form and instruction Attachment B_Interview_Guide_Grantees.docx
Private Sector 18 27 0

2012-09-18-04:00

0935-0201 201205-0935-002 0935
             
        "Workflow Assessment for Health IT Toolkit Evaluation"
             
          
        
The evaluation will consist of field assessments of use of the Workflow toolkit in 18 small- and medium-sized practices and gathering feedback from two Health IT Regional Extension Centers (RECs) who are providing support to some of these practices. The evaluation will address the issues of system validation as classically defined in software engineering: determining whether the software or system actually meets the requirements of the user to perform the relevant tasks. The evaluation will answer the following questions: oAre results correct? Are individual tools included in the Workflow toolkit accurate? Does workflow assessment with the Workflow toolkit provide accurate information the practice can act upon? oDoes knowledge change? Does user knowledge and capacity change? Does user knowledge of workflow in their own practice change? oDo decisions change? Do user decisions about workflow assessment change? Do user decisions about health information technology (health IT) implementation change? oDo outcomes change? Are changes in workflow favorable? Are changes in clinical practices favorable? Are changes to the practice favorable? Are changes for patients favorable? 2015-10-31-04:00 Active Doris Lefkowitz 3014271477 No No No 4380 3114 0

Creation of Clinic Study Team No Health Immunization Management Private Sector 252 147 0

Pre-Workflow Toolkit Interview No Health Immunization Management
Form #2 Attachment B - Pre-Workflow Toolkit Interview Guide REC Yes Yes Paper Only Form and instruction Attachment B -- Pre-Workflow Toolkit Interview Guide REC.docx Form #1 Attachment A - Pre-Workflow Toolkit Interview Guide Practice Yes Yes Paper Only Form and instruction Attachment A -- Pre-Workflow Toolkit Interview Guide Practice.docx
Private Sector 258 129 0

Observations No Health Immunization Management
Form #3 Workflow Toolkit Activities and Perspectives Observation Log Yes Yes Paper Only Form and instruction Attachment C -- Workflow Toolkit Activities and Perspectives Observation Log.docx
Private Sector 1032 2064 0

Usage Logs No Health Immunization Management
Form #4 Workflow Assessment Usage Log Yes Yes Paper Only Form and instruction Attachment D -- Workflow Assessment Usage Log.docx
Private Sector 2580 645 0

Post-Workflow Toolkit Interview No Health Immunization Management
Form #5 Attachment E - Post Workflow toolkit Interview Guide Practice Yes Yes Paper Only Form and instruction Attachment E -- Post-Workflow Toolkit Interview Guide Practice.docx Form #6 Attachment F - Post Workflow Toolkit Interview Guide REC Yes Yes Paper Only Form and instruction Attachment F -- Post-Workflow Toolkit Interview Guide REC.docx
Private Sector 258 129 0

2012-10-12-04:00

0935-0202 201205-0935-003 0935
             
        "Demonstration of Health Literacy Universal Precautions Toolkit"
             
          
        
The purpose of this demonstration project is to explore whether the Toolkit helps motivated practices to make changes intended to improve communication with and support for patients of all literacy levels. Twelve primary care practices will be recruited to implement at least four tools from the Health Literacy Universal Precautions Toolkit. The project team will provide participating practices with limited technical assistance throughout the implementation period. Data regarding the assistance provided will contribute to the team's assessment of the ease with which specific tools can be implemented and will provide insight into additional resources and guidance that might be valuable to add to the Toolkit. 2014-10-31-04:00 Active Doris Lefkowitz 3014271477 No No No 3974 1469 0

Practice Screening Calls No Health Immunization Management
Form #1 Practice Screening Calls Yes Yes Paper Only Form and instruction Attachment C -- Practice Screening Calls.doc
Private Sector 20 7 0

Follow-up Recruitment Calls No Health Immunization Management
Form #2 Follow-up Recruitment Calls Yes Yes Paper Only Form and instruction Attachment D -- Follow-Up Recruitment Call.docx
Private Sector 30 23 0

Health Literacy Assessment Questions No Health Immunization Management
Form #3 Health Literacy Assessment Questions Yes Yes Paper Only Form and instruction Attachment E -- Health Literacy Assessment Questions.doc
Private Sector 120 70 0

Implementation Tracking Form No Health Immunization Management
Form #4 Implementation Tracking Form Yes Yes Paper Only Form and instruction Attachment F -- Implementation Tracking Form.docx
Private Sector 72 6 0

Webinar/Orientation No Health Immunization Management
Form #5 Webinar/Orientation Presentation Yes Yes Fillable Fileable Form and instruction Attachment G -- Webinar Presentation.pptx
Private Sector 48 96 0

Patient Survey No Health Immunization Management
Form #6 Patient Survey Yes Yes Fillable Fileable Form and instruction Attachment I.1 -- Patient Survey.docx
Individuals or Households 1200 600 0

Survey Using Items from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) No Health Immunization Management
Form #7 Survey Using Items from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Yes Yes Paper Only Form and instruction Attachment J -- Consumer Assessment of Healthcare Providers and Systems Questionnaire.doc
Individuals or Households 1800 360 0

Medication Review Form No Health Immunization Management
Form #8 Medication Review Form Yes Yes Paper Only Form and instruction Attachment K -- Medication Review Form.doc
Private Sector 120 60 0

Practice Staff Survey - Pre-implementation No Health Immunization Management
Form #9 Practice Staff Survey - Pre-implementation Yes Yes Paper Only Form and instruction Attachment L -- Practice Staff Survey - Pre-Implementation.docx
Private Sector 216 72 0

Practice Staff Survey - Post-implementation No Health Immunization Management
Form #10 Practice Staff Survey - Post-implementation Yes Yes Paper Only Form and instruction Attachment M -- Practice Staff Survey - Post-Implementation.docx
Private Sector 216 90 0

Health Literacy Team Leader Survey - Pre-implementation No Health Immunization Management
Form #11 Health Literacy Team Leader Survey - Pre-implementation Yes Yes Paper Only Form and instruction Attachment N -- Health Literacy Team Leader Survey - Pre-Implementation.docx
Private Sector 12 3 0

Health Literacy Team Leader Survey - Post-implementation No Health Immunization Management
Form #12 Health Literacy Team Leader Survey - Post-implementation Yes Yes Paper Only Form and instruction Attachment O -- Health Literacy Team Leader Survey - Post-Implementation.docx
Private Sector 12 4 0

Check-in Phone Calls No Health Immunization Management
Form #13 Check-in Phone Calls Yes Yes Paper Only Form and instruction Attachment S -- Check-in Phone Calls.docx
Private Sector 48 24 0

Health Literacy Team Leader Interview - Pre-implementation No Health Immunization Management
Form #14 Health Literacy Team Leader Interview - Pre-implementation Yes Yes Paper Only Form and instruction Attachment Q -- Health Literacy Team Leader Interviews - Pre-Implementation.doc
Private Sector 12 6 0

Health Literacy Team Leader Interview - Post-implementation No Health Immunization Management
Form #15 Health Literacy Team Leader Interview - Post-implementation Yes Yes Paper Only Form and instruction Attachment R -- Health Literacy Team Leader Interviews - Post-Implementation.doc
Private Sector 12 18 0

Health Literacy Team Member Interview - Post-implementation No Health Immunization Management
Form #16 Health Literacy Team Member Interview - Post-implementation Yes Yes Paper Only Form and instruction Attachment T -- Health Literacy Team Member Interview - Post-Implementation.doc
Private Sector 12 18 0

Practice Staff Member Interview - Post-implementation No Health Immunization Management
Form #17 Practice Staff Member Interview - Post-implementation Yes Yes Paper Only Form and instruction Attachment U -- Practice Staff Member Interview - Post-Implementation.doc
Private Sector 24 12 0

2012-10-12-04:00

0935-0203 201207-0935-001 0935
             
        "American Recovery and Reinvestment Act "Developing a Registry of Registries""
             
          
        
By creating a central point of collection for information about all patient registries in the United States, the Registry of Patient Registries (RoPR) helps to further AHRQ's goals by making information regarding quality, appropriateness, and effectiveness of health services (and patient registries in particular) more readily available and centralized. 2015-10-31-04:00 Active Doris Lefkowitz 3014271477 Yes No No 2280 1330 0

New RoPR Record No Health Immunization Management
Form #1 RoPR Data Collection Instrument Yes Yes Fillable Fileable Form and instruction Attachment A -- RoPR Data Colection Instrument.docx
Private Sector 1520 1140 0

Review/update RoPR Record No Health Immunization Management
Form #2 RoPR Data Collection Instrument Yes Yes Fillable Fileable Form and instruction Attachment A -- RoPR Data Colection Instrument.docx
Private Sector 760 190 0

2012-10-12-04:00

0935-0204 201206-0935-001 0935
             
        "Adapting Best Practices for Medicaid Readmissions"
             
          
        
One particular mission of AHRQ is to improve the efficiency of health care through reducing unnecessary health care costs while maintaining or improving quality. The proposed data collection supports this goal through developing strategies to assist safety net hospitals in reducing readmissions for Medicaid patients. Previous research has shown that a focus on transitional care, including needs assessment, discharge planning, post-discharge intervention, and care coordination can reduce avoidable readmissions 2015-12-31-05:00 Active Doris Lefkowitz 3014271477 No No No 2400 640 0

Medical records review No Health Immunization Management
Form #1 Medical Records Review Tool (Drivers) Yes Yes Fillable Fileable Form and instruction Attachment A -- Medical Records Review Tool (Drivers).doc Form #2 Medical Records Review Tool (Test Strategies) Yes Yes Fillable Fileable Form and instruction Attachment B -- Medical Records Review Tool (Test Strategies).doc
Private Sector 480 160 0

Patient/family /caregiver interviews No Health Immunization Management
Form #3 Patient-Family-caregiver Interview Tool (Drivers) Yes Yes Paper Only Form and instruction Attachment C -- Patient-Family-Caregiver Interview Tool (Drivers).doc Form #4 Patient-Family-Caregiver Interview Tool (Test Strategies) Yes Yes Paper Only Form and instruction Attachment D -- Patient-Family-Caregiver Interview Tool (Test Strategies).doc
Individuals or Households 960 320 0

Provider interviews No Health Immunization Management
Form #6 Provider Interview Tool (Test Strategies) Yes Yes Paper Only Form and instruction Attachment F -- Provider Interview Tool (Test Strategies).doc Form #5 Provider Interview Tool (Baseline) Yes Yes Paper Only Form and instruction Attachment E -- Provider Interview Tool (Drivers).doc
Private Sector 960 160 0

2012-12-11-05:00

0935-0205 201209-0935-002 0935
             
        "CHIPRA Pediatric Quality Measures Program (PQMP) Candidate Measure Submission Form"
             
          
        
Section 401(a) of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Public Law 111-3, amended the Social Security Act ("the Act") to enact section 1139A (42 U.S.C. 1320b--9a). Section 1139A(b) charged the Department of Health and Human Services (HHS) with improving pediatric health care quality measures. Since CHIPRA was passed, AHRQ and the Centers for Medicare & Medicaid Services (CMS) have been working together to implement selected provisions of the legislation related to children's health care quality. As required by CHIPRA, by January 1, 2011, AHRQ and CMS established the CHIPRA Pediatric Quality Measures Program (PQMP) in accordance with section 1139A(b)(1) of the Act to enhance select children's health care quality measures and develop new measures (http://www.ahrq.gov/chipra). 2015-12-31-05:00 Active Doris Lefkowitz 3014271477 No No No 75 244 0

CHIPRA PQMP Candidate Measure Submission Form No Health Immunization Management
Form #1 CHIPRA PQMP Candidate Measure Submission Form Yes Yes Fillable Fileable Form and instruction Attachment A -- CHIPRA PQMP Candidate Measure Submission Form.docx
Private Sector 75 244 0

2012-12-20-05:00

0935-0206 201209-0935-003 0935
             
        "Online Application Order Form for Products from the Healthcare Cost and Utilization Project (HCUP)"
             
          
        
To support AHRQ's mission to improve health care through scientific research, HCUP databases and software tools are disseminated to users outside of the Agency through a mechanism known as the HCUP Central Distributor. The HCUP Central Distributor assists qualified researchers to access uniform research data across multiple states with the use of one application process. The HCUP databases disseminated through the Central distributor are referred to as "restricted access public release files"; that is, they are publicly available, but only under restricted conditions. This information collection request is for the activities associated with the HCUP database application process not the collection of health care data for HCUP databases. 2015-12-31-05:00 Active Doris Lefkowitz 3014271477 No No No 3600 600 0

HCUP Application Form No Health Consumer Health and Safety
Form #1 NIS Application Yes Yes Fillable Fileable Form and instruction NIS Application.pdf Form #3 NEDS Application Yes Yes Fillable Fileable Form and instruction NEDS Application.pdf Form #4 SID & SASD &SEDD Application Yes Yes Fillable Fileable Form and instruction SID & SASD & SEDD Application.pdf Form #2 KID Application Yes Yes Fillable Fileable Form and instruction KID Application.pdf
Private Sector 1200 200 0

HCUP DUA Training No Health Immunization Management
Form #1 HCUP Data Use Agreement Training Yes Yes Fillable Fileable Form and instruction HCUP Data Use Agreement Training.docx
Private Sector 1200 300 0

HCUP DUA No Health Consumer Health and Safety
Form #6 SEDD Data Use Agreement Yes Yes Fillable Fileable Form and instruction SEDD Data Use Agreement.docx Form #5 SASD Data Use Agreement Yes Yes Fillable Fileable Form and instruction SASD Data Use Agreement.docx Form #2 KID Data Use Agreement Yes Yes Fillable Fileable Form and instruction KID Data Use Agreement.docx Form #3 NEDS Data Use Agreement Yes Yes Fillable Fileable Form and instruction NEDS Data Use Agreement.docx Form #4 SID Data Use Agreement Yes Yes Fillable Fileable Form and instruction SID Data Use Agreement.docx Form #1 NIS Data Use Agreement Yes Yes Fillable Fileable Form and instruction NIS Data Use Agreement.docx
Private Sector 1200 100 0

2012-12-26-05:00

0935-0208 201301-0935-001 0935
             
        "Using Health Information Technology in Practice Redesign: Impact of Health Information Technology on Workflow"
             
          
        
The goal of the project is to understand the impact of implementing health IT-enabled care coordination on workflow within small community-based primary care clinics in various stages of practice redesign. The focus of this study is the interaction of health IT and care coordination workflow in the context of practice redesign. This study will focus on clinic staff caring for patients with diabetes within small primary care clinics to understand enablers and barriers to care coordination workflow through the use of health IT. 2016-03-31-04:00 Active Doris Lefkowitz 3014271477 No No No 420 252 0

Project orientation meeting No Health Public Health Monitoring
Form #1 Introduction for Orientation Meeting Yes Yes Paper Only Form and instruction Attachment A -- Introduction for Orientation Meeting.pdf
Private Sector 60 30 0

Staff Semi-Structured Interviews No Health Public Health Monitoring
Form #2 Staff Interview Guide Yes Yes Paper Only Form and instruction Attachment D -- Staff Interview Guide.doc
Private Sector 84 84 0

Technology Acceptance Model Survey No Health Public Health Monitoring
Form #3 Technology Acceptance Model Survey Yes Yes Paper Only Form and instruction Attachment E -- Technology Acceptance Model Survey.doc
Private Sector 84 42 0

Patient Semi-Structured Interviews No Health Public Health Monitoring
Form #4 Patient Interview Guide Yes Yes Paper Only Form and instruction Attachment F -- Patient Interview Guide.doc
Individuals or Households 64 64 0

Patient Activation Measures Survey No Health Public Health Monitoring
Form #5 Patient Activation Measures Survey Yes Yes Fillable Fileable Form and instruction Attachment G -- Patient Activation Measure Survey.doc
Individuals or Households 64 13 0

Summary of Diabetes Self Care Activities Survey No Health Public Health Monitoring
Form #6 Summary of Diabetes Self-Care Activities Survey Yes Yes Fillable Fileable Form and instruction Attachment H -- Summary of Diabetes Self-Care Activities Survey.doc
Individuals or Households 64 19 0

2013-03-19-04:00

0935-0209 201304-0935-002 0935
             
        "Applying Novel Methods to Better Understand the Relationship between Health IT and Ambulatory Care Workflow Redesign"
             
          
        
The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) approve, under the Paperwork Reduction Act of 1995, AHRQ's collection of information for the project Applying Novel Methods to Better Understand the Relationship between Health IT and Ambulatory Care Workflow Redesign. The data to be collected consists of interviews and focus groups with clinical, non-clinical, and management staff about their experiences with new health information technology (IT) in an ambulatory care facility. The overall goal of this study is to characterize the relationship between health IT implementation and health care workflow in six (6) small and medium-sized ambulatory care practices implementing patient-centered medical homes (PCMH), with a focus on the influence of behavioral and organizational factors and the effects of disruptive events. 2016-05-31-04:00 Active Doris Lefkowitz 3014271477 No No No 120 105 0

Semi-Structured Interview Guide No Health Public Health Monitoring
Form #1 Semi-Structured Interview Guide Yes Yes Paper Only Form and instruction Attachment C Semi-Structured Interview Guide.docx
Private Sector 60 60 0

Focus Group Guide No Health Public Health Monitoring
Form #2 Focus Group Guide Yes Yes Paper Only Form and instruction Attachment D Focus Group Guide.docx
Private Sector 60 45 0

2013-05-23-04:00

0935-0210 201304-0935-001 0935
             
        "Assessing the Knowledge and Educational Needs of Students of Health Professions on Patient-Centered Outcomes Research"
             
          
        
patient-centered outcomes research (PCOR)is research that helps clinicians, patients and other caregivers make decisions about health care choices by highlighting comparisons and outcomes that matter to people, such as survival, function, symptoms, and health related quality of life. This survey is intended to assess students' and faculties needs and preferences for integrating PCOR into the health professions' curricula, learning environment, and other training opportunities through a series of structured interviews with selected faculty members and an online survey directed at students in the health professions. The outcome will be a roadmap, which will include a set of recommendations for strategies and tools for educational and dissemination activities, along with a suggested approach and timeline for implementation of the recommendations. 2015-05-31-04:00 Active Doris Lefkowitz 3014271477 No No No 1824 324 0

Faculty Interview No Health Consumer Health and Safety
Form #1 Faculty Interview Yes Yes Paper Only Form and instruction Attachment C -- Faculity Interview.docx
Private Sector 24 24 0

Student Survey No Health Consumer Health and Safety
Form #2 Student Survey Yes Yes Fillable Fileable Form and instruction Attachment A -- Student_Survey.docx
Individuals or Households 1800 300 0

2013-05-23-04:00

0935-0211 201304-0935-003 0935
             
        "Pilot Test of the Proposed Value and Efficiency Surveys and Communicating About Value Checklist "
             
          
        
Given the widespread impact of cost and waste in health care, AHRQ will develop the Value and Efficiency (VE) Surveys for hospitals and medical offices. These surveys will measure staff perceptions about what is important in their organization and what attitudes and behaviors related to value and efficiency are supported, rewarded, and expected. The surveys will help hospitals and medical offices to identify and discuss strengths and weaknesses within their individual organizations. They can then use that knowledge to develop appropriate action plans to improve their value and efficiency. To develop these tools AHRQ will recruit medical staff from 42 hospitals and 96 medical offices to participate in cognitive testing and pretesting. In addition to the VE surveys, AHRQ also intends to develop a Communicating About Value Checklist (CV checklist). The objective of the CV checklist is to aid clinicians in having conversations with patients about value. 2014-07-31-04:00 Active Doris Lefkowitz 3014271477 No No No 5066 2534 0

Cognitive interviews for the Hospital VE survey No Health Consumer Health and Safety
Form #1 Cognitive Interview Guide for Hospital VE Survey Yes Yes Paper Only Form and instruction Attachment A - Cognitive Interview Guide for Hospital VE Survey.docx
Private Sector 9 14 0

Cognitive interviews for the Medical Office VE survey No Health Consumer Health and Safety
Form #2 Cognitive Interview Guide for Medical Office VE Survey Yes Yes Paper Only Form and instruction Attachment B - Cognitive Interview Guide for Medical Office VE Survey.docx
Private Sector 9 14 0

Pretest for the Hospital VE survey No Health Consumer Health and Safety
Form #3 Pretest Survey for Hospital VE Survey Yes Yes Paper Only Form and instruction Attachment C - Pretest Survey for Hospital VE Survey_1-17-13.docx
Private Sector 4032 1008 0

Pretest for the Medical Office VE survey No Health Consumer Health and Safety
Form #4 Pretest Survey for Medical Office VE Survey Yes Yes Paper Only Form and instruction Attachment D - Pretest Survey for Medical Office VE Survey_1-17-13.docx
Private Sector 504 126 0

POC Administration of the Hospital VE survey No Health Consumer Health and Safety
Form #5 Site-level POC Instructions for Hospital VE Survey Yes Yes Paper Only Form and instruction Attachment E - Site-level POC Instructions for Hospital VE Survey.docx
Private Sector 42 672 0

POC Administration of the Medical Office VE survey No Health Consumer Health and Safety
Form #6 Site-level POC Instructions for Medical Office VE Survey Yes Yes Paper Only Form and instruction Attachment F - Site-level POC Instructions for Medical Office VE Survey.docx
Private Sector 96 576 0

Medical office information form No Health Consumer Health and Safety
Form #7 Medical Office Information Form Yes Yes Paper Only Form and instruction Attachment I - Medical Office Information Form.docx
Private Sector 96 16 0

Survey to identify items for CV checklist No Health Consumer Health and Safety
Form #8 CV Checklist Survey Yes Yes Paper Only Form and instruction Attachment J - CV Checklist Survey.docx
Private Sector 160 40 0

Cognitive interviews for the CV checklist No Health Consumer Health and Safety
Form #9 Cognitive Interview Guide for CV Checklist Yes Yes Paper Only Form and instruction Attachment K - Cognitive Interview Guide for CV Checklist.docx
Private Sector 18 18 0

Pretest for the CV checklist No Health Consumer Health and Safety
Form #10 Draft CV Checklist Evaluation Yes Yes Paper Only Form and instruction Attachment M - Draft CV Checklist Evaluation.docx
Private Sector 100 50 0

2013-07-24-04:00

0935-0212 201305-0935-001 0935
             
        "Patient-Reported Health Information Technology and Workflow"
             
          
        
The use of patient-reported information is not yet widely integrated into health IT. This project will fill the gaps in the current literature by exploring the influence of sociotechnical factors--for clinicians and their office staff, and for patients--in capturing and using patient-reported information in ambulatory health IT systems and associated workflows. The goal of the project is to answer the following research questions: o How does the use of health IT to capture and use patient-reported information support or hinder the workflow from the viewpoints of clinicians, office staff, and patients? o How does the sociotechnical context influence workflow related to the capture and use of patient-reported information? o How do practices redesign their workflow to incorporate the capture and use of patient-reported information? 2016-07-31-04:00 Active Doris Lefkowitz 3014271477 No No No 336 215 0

Preliminary Conference Call No Health Health Care Services
Form #1 Preliminary Conference Call Discussion Guide Yes Yes Paper Only Form and instruction Attachment A -- Preliminary Conference Call Discussion Guide.docx
Private Sector 12 12 0

Pre-Visit Questionnaire No Health Public Health Monitoring
Form #2 Pre-Visit Questionnaire Yes Yes Fillable Fileable Form and instruction Attachment B -- Pre-Visit Questionnaire.docx
Private Sector 6 6 0

Practice Tour No Health Public Health Monitoring
Form #3 Practice Tour Guide Yes Yes Paper Only Form and instruction Attachment C -- Practice Tour Guide.docx
Private Sector 6 6 0

Interviews with Practice Manager and Physician Leader No Health Public Health Monitoring
Form #4B Guide for Interview with Physician Leader Yes Yes Paper Only Form and instruction Attachment E -- Guide for Interview with Physician Leader.docx Form #4 Guide for Interview with Practice Manager Yes Yes Paper Only Form and instruction Attachment D -- Guide for Interview with Practice Manager.docx
Private Sector 12 12 0

Interviews with Clinicians and Office Staff No Health Public Health Monitoring
Form #5 Interview Guide for Clinicians and Office Staff Yes Yes Paper Only Form and instruction Attachment G -- Interview Guide for Clinicians and Office Staff.docx
Private Sector 114 114 0

Survey of Clinicians and Office Staff No Health Public Health Monitoring
Form #6 Clinician and Office Staff Survey Yes Yes Fillable Fileable Form and instruction Attachment I -- Clinician and Office Staff Survey.docx
Private Sector 138 35 0

Patient Interviews No Health Public Health Monitoring
Form #7 Patient Interview Guide Yes Yes Paper Only Form and instruction Attachment J -- Patient Interivew Guide.docx
Individuals or Households 36 18 0

Post Visit Follow-up to Review the Workflow Process Map(s) No Health Public Health Monitoring
Form #8 Interview Guide for Follow-Up Yes Yes Paper Only Form and instruction Attachment L -- Interview Guide for Follow-Up.docx
Private Sector 12 12 0

2013-07-24-04:00

0935-0213 201305-0935-002 0935
             
        "Improving Sickle Cell Transitions of Care through Health Information Technology Phase 1"
             
          
        
This project is the first phase in AHRQ's effort toward the development of a health information technology (HIT) enabled tool designed to aid adolescents and young adults with sickle cell disease (SCD) during transitions of care. 2014-08-31-04:00 Active Doris Lefkowitz 3014271477 No No No 353 249 0

Focus Group Screener No Health Health Care Services
Form #1 Focus Group Screening Questionnaires Yes Yes Paper Only Form and instruction Attachment 14 - Focus Group Screening Questionnaires.docx
Private Sector 150 13 0

Demographic Questionnaire No Health Health Care Services
Form #2 Demographic Questionnaires Yes Yes Paper Only Form and instruction Attachment 8 - Demographic Questionnaires.doc
Private Sector 100 10 0

Provider Focus Groups No Health Health Care Services
Form #3 Moderator Guide and Respondent Materials for Providers Yes Yes Paper Only Form and instruction Attachment 6 - Moderator Guide & Respondent Materials for Providers.doc
Private Sector 20 40 0

Parent/Caregiver Focus Groups No Health Health Care Services
Form #4 Moderator Guide and Respondent Materials for Parents/Caregivers Yes Yes Paper Only Form and instruction Attachment 5 - Moderator Guide & Respondent Materials for Parents Caregivers.doc
Individuals or Households 30 60 0

IT Developer Focus Group No Health Public Health Monitoring
Form #5 Moderator Guide for IT Developers Yes Yes Paper Only Form and instruction Attachment 7 - Moderator Guide for IT Developers.doc
Private Sector 10 40 0

Patients 9-13 Focus Group No Health Health Care Services
Form #6 Moderator Guide and Respondent Materials for Patients Ages 9-13 Yes Yes Paper Only Form and instruction Attachment 1 - Moderator Guide & Respondent Materials for Patients Ages 9-13.doc
Individuals or Households 10 20 0

Patients 14-17 Focus Group No Health Health Care Services
Form #7 Moderator Guide and Respondent Materials for Patients Ages 14-17 Yes No Paper Only Form and instruction Attachment 2 - Moderator Guide & Respondent Materials for Patients Ages 14-17.doc
Individuals or Households 10 20 0

Patients 18 & older Focus Group No Health Health Care Services
Form #8 Moderator Guide and Respondent Materials for Patients Ages 18+ Yes Yes Paper Only Form and instruction Attachment 3 - Moderator Guide & Respondent Materials for Patients Ages 18+.doc
Individuals or Households 10 20 0

Patients mixed ages Focus Group No Health Health Care Services
Form #9 Moderator Guide and Respondent Materials for Patients - Mixed Ages Yes Yes Paper Only Form and instruction Attachment 4 - Moderator Guide & Respondent Materials for Patients - Mixed Ages.doc
Individuals or Households 10 20 0

Key Informant Interviews No Health Health Care Services
Form #10 Key Informant Interview Guides Yes Yes Paper Only Form and instruction Attachment 9 - Key Informant Interview Guides.DOCX
Private Sector 3 6 0

2013-08-12-04:00

0935-0214 201306-0935-001 0935
             
        "A PROTOTYPE CONSUMER REPORTING SYSTEM FOR PATIENT SAFETY EVENTS"
             
          
        
The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) approve, under the Paperwork Reduction Act of 1995, AHRQ's collection of information for a Prototype Consumer Reporting System for Patient Safety Events. This project aims to design and evaluate a prototype system that can collect voluntary reports from patients about health care safety using standard definitions and formats that would enable systematic analysis and identification of opportunities for safety improvement. 2015-08-31-04:00 Active Doris Lefkowitz 3014271477 No No No 924 518 0

Safety event intake form and follow up No Health Immunization Management
Form #3 Intake reporting form follow up Yes Yes Fillable Fileable Form and instruction Attachment E -- Intake Reporting Form Follow Up.doc Form #2 Intake reporting form - phone version Yes Yes Fillable Fileable Form and instruction Attachment D -- Intake Reporting Form -- Phone Version.doc Form #1 Intake reporting form - web version Yes Yes Fillable Fileable Form and instruction Attachment B -- Intake Reporting Form - Web Version.doc
Individuals or Households 840 490 0

Health care provider follow up No Health Immunization Management
Form #4 Health care provider follow-up form Yes Yes Fillable Fileable Form and instruction Attachment G -- Health Care Provider Followup.docx
Private Sector 84 28 0

2013-08-23-04:00

0935-0215 201308-0935-002 0935
             
        "Evaluation of the 2009 CHIPRA Quality Demonstration Grant Program: Survey Data Collection"
             
          
        
Section 401(a) of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Pub. L. 111-3, amended the Social Security Act (the Act) to enact section 1139A (42 U.S.C. 1320b-9a). AHRQ is requesting approval from the Office of Management and Budget (OMB) for the collection of quantitative data through a survey of pediatricians and family medicine physicians to support a comprehensive, mixed-methods evaluation of the quality demonstration grants authorized under section 1139A(d) of the Act (Attachment A). AHRQ's mission of improving the quality and effectiveness of health care in the United States aligns with evaluating whether, and through what mechanism, projects funded by the CHIPRA demonstration grants improve the quality of care received by children in Medicaid and the Children's Health Insurance Program (CHIP). 2015-09-30-04:00 Active Doris Lefkowitz 3014271477 No No No 1200 300 0

Pediatrician and Family Physicians Survey No Health Immunization Management
Form #1 Pediatrician and Family Physician Survey Yes Yes Paper Only Form and instruction Attachment B - Pediatrician and Family Physician Survey.docx
Private Sector 1200 300 0

2013-09-26-04:00

0935-0216 201309-0935-001 0935
             
        "Pretest of the Ambulatory Surgery/Procedure Survey on Patient Safety Culture"
             
          
        
Given the widespread impact of ASCs on patient safety, the new Ambulatory Surgery/Procedure Survey on Patient Safety Culture (Ambulatory Surgery SOPS) will measure ASC staff perceptions about what is important in their organization and what attitudes and behaviors related to patient safety culture are supported, rewarded, and expected. The survey will help ASCs to identify and discuss strengths and weaknesses of patient safety culture within their individual facilities. They can then use that knowledge to develop appropriate action plans to improve their practices and their culture of patient safety. This survey is designed for use in ASCs that practice all types of surgical procedures including those that require incisions and less invasive or non-surgical procedures such as gastrointestinal procedures or pain management injections. 2015-07-31-04:00 Active Doris Lefkowitz 3014271477 No No No 584 395 0

Cognitive interviews No Health Immunization Management
Form # 1 Cognitive Interview Guide Yes Yes Paper Only Form and instruction Attachment A - Cognitive Interview Guide for Ambulatory Surgery Survey.docx
Private Sector 15 23 0

Pretest for the Ambulatory Surgery SOPS No Health Immunization Management
Form # 2 Ambulatory Surgery SOPS Yes Yes Paper Only Form and instruction Attachment B - Ambulatory Surgery SOPS.docx
Private Sector 529 132 0

POC Administration of the survey No Health Immunization Management
Form # 3 Site-level POC Instructions for Survey Yes Yes Paper Only Form and instruction Attachment C - Site-level POC Instructions for Survey.docx
Private Sector 40 240 0

2013-10-31-04:00

0937-0025 201310-0937-002 0937
             
        "Reference Request for Applicants to the U.S. Public Health Service Commissioned Corps"
             
          
        
The forms will be used by individuals to apply for appointment in the U.S. Public Health Service Commissioned Corps and to obtain references as part of the application process. Information supplied on the forms will be used by appropriate Department officials to evaluate candidates for appointment. 2016-11-30-05:00 Active Sherrette Funn-Coleman 2026905683 No No No 14900 4900 30000

PHS-50 No Health Health Care Services Individuals or Households 2500 2500 30000

PHS-1813 No Health Health Care Services Individuals or Households 4000 1000 0

Interested Health Professionals No Health Health Care Services Individuals or Households 8400 1400 0

2013-11-25-05:00

0937-0166 201210-0937-001 0937
             
        "42 C.F.R. Subpart B:  Sterilization of Persons in Federally Assisted Family Planning Projects"
             
          
        
These regulations and informed consent procedures are associated with Federally funding sterilization services. Selected consent forms are audited during the site visits and program reviews by Federal programs to ensure compliance with the regulations and protection of individual's rights. 2015-10-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 200000 125000 0

Information disclosure for sterilization consent forms No Health Public Health Monitoring
0937-0166 sterlization form No No Printable Only Form 0937-0166sterilization consent form OMB 11 2009 approval.doc
Individuals or Households 100000 100000 0

Record Keeping for sterilization consent forms No Health Health Care Services
0937-0166 Sterilization form No No Printable Only Form 0937-0166sterilization consent form OMB 11 2009 approval.doc
Individuals or Households 100000 25000 0

2012-10-19-04:00

0937-0191 201310-0937-001 0937
             
        "Application Packets for Real Property for Public Health Purposes"
             
          
        
State and local governments and nonprofit institutions use these applications to apply for excess/surplus, underutilized/unutilized and off-site government real property. These applications are used to determine if institutions/organizations are eligible to purchase, lease or use prop. under the provisions of surplus property program. 2016-12-31-05:00 Active Sherrette Funn-Coleman 2026905683 No No No 20 4000 3600

Application Packets for Real Property for Public Health Purposes No Health Public Health Monitoring State, Local, and Tribal Governments 20 4000 3600

2013-12-13-05:00

0937-0198 201312-0937-001 0937
             
        "Public Health Service Policies on Research Misconduct (42 CFR Part 93)"
             
          
        
Section 493 of the Public Health Service Act and 42 CFR Part 93 requires each institution that applies for research and research- related grants to estabish policies and procedures for investigating and reporting instances of alleged or apparent research miscondut for activity supported by PHS funds and to report such instances to the Secretary. 2015-06-30-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 6096 1016 0

Public Health Service Policies on Research Misconduct (42 CFR Part 93) No Health Health Care Services
6349 Annual Report Possible Research Misconduct No No Paper Only Form Revised_form6349.pdf 6349 PHS No No Printable Only Form 0937-0198 ClearanceForm PHS 6349.pdf
Private Sector 6096 1016 0

2013-12-19-05:00

0938-0022 201008-0938-024 0938
             
        "Home Health Agency Cost Report and Supporting Regulations in 42 CFR 413.20, 413.24, 413.106"
             
          
        
Form CMS-1728-94 is the form used by Home Health Agencies to report their health care costs to determine the amount of reimbursement for services furnished to Medicare beneficiaries. 2014-02-28-05:00 Active Bonnie Harkless 4107865666 No No Uncollected 7479 1690254 0

Home Health Agency Cost Report and Supporting Regulations in 42 CFR 413.20, 413.24, 413.106 No Health Health Care Services
Yes Yes Printable Only Instruction pr2_3295.docx Yes Yes Printable Only Instruction pr2_3215.3_to_3246.docx Yes Yes Printable Only Instruction pr2_3215.3_to_3238.docx Yes Yes Printable Only Instruction pr2_3290_exhibit_1.docx CMS-1728-94 Medicare Cost Report Forms Yes Yes Fillable Printable Form R15P232f.xlsx Yes Yes Printable Only Instruction pr2_32_toc.docx Yes Yes Printable Only Instruction pr2_3200_to_3215.2.docx
Private Sector 7479 1690254 0

2010-10-04-04:00

0938-0023 201106-0938-009 0938
             
        "Attending Physicians Statement and Documentation of Medicare Emergency and Supporting Regulations in 42 CFR Section 424.103"
             
          
        
Form CMS-1771 requires the attending physician to attest that the hospitalization was required under the regulatory emergency definition (42 CFR 424.101) and give clinical documentation to support the claim. This allows a nonparticipating hospital to be paid for emergency services rendered to a Medicare beneficiary. 2014-07-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 200 50 0

Attending Physicians Statement and Documentation of Medicare Emergency and Supporting Regulations in 42 CFR Section 424.103 No Health Health Care Services
CMS-1771 Attending Physician's Statement and Documentation of Medicare Emergency Yes No Fillable Printable Form cms1771p1[1].pdf
Private Sector 200 50 0

2011-07-24-04:00

0938-0027 201203-0938-006 0938
             
        "Request for Certification as Supplier of Portable X-Ray and Portable X-Ray Survey Report Form (CMS-1880 and 1882)"
             
          
        
The Medicare program requires portable X-ray suppliers to be surveyed for health and safety standards. The CMS-1882 is the survey form that records survey results. The CMS-1880 is used by the surveyor to determine if a portable X-ray applicant meets the eligibility requirements. 2015-06-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 86 151 0

Request for Certification as Supplier of Portable X-Ray and Portable X-Ray Survey Report Form No Health Health Care Services
CMS-1882 Medicare/Medicaid Portable X-ray Survey Report Yes No Fillable Printable Form and instruction CMS-1882 Portible X-Ray Survey Report.pdf CMS-1880 Request for Certification as a Supplier of Portable X-ray Services Yes No Fillable Printable Form and instruction CMS 1880 Request For Certification.pdf
State, Local, and Tribal Governments 86 151 0

2012-06-01-04:00

0938-0035 201305-0938-008 0938
             
        "Social Security Office (SSO) Report of State Buy-in Problems"
             
          
        
The CMS-1957 is issued to facilitate communications among the Social Security District Offices, Medicaid State Agencies and CMS Central Office in the resolution of beneficiary entitlement under State Buy-in. It's used when a problem arises which cannot be resolved through the normal data exchange. 2016-09-30-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 5600 1816 0

Social Security Office (SSO) Report of State Buy-in Problems No Health Health Care Services
CMS-1957 SSO Report of State Buy-in Problems Yes No Fillable Fileable Form CMS-1957 Collection Instrument.pdf
Individuals or Households 5200 1716 0

Social Security Office (SSO) Report of State Buy-in Problems No Health Health Care Services
CMS-1957 Social Security Office (SSO) Report of State Buy-in Problems Yes No Fillable Fileable Form CMS-1957 Collection Instrument.pdf
Federal Government 400 100 0

2013-09-20-04:00

0938-0037 201102-0938-001 0938
             
        "Outpatient Rehabilitation Cost Report and Supporting Regulations in 42 CFR 413.20 and 413.24 (CMS-2088-92)"
             
          
        
Outpatient rehabilitation cost report and supporting regulations in 42 CFR 413.20, 413.24, and 413.106 2014-03-31-04:00 Active William Parham 4107864669 No No No 596 59600 0

Outpatient Rehabilitation Cost Report and Supporting Regulations in 42 CFR 413.20 and 413.24 No Health Health Care Services
Yes Yes Paper Only Instruction Insructions and Specs.docx CMS-2008-92 Cost Report Yes Yes Paper Only Form 2088-92.xlsx
Private Sector 596 59600 0

2011-03-21-04:00

0938-0046 201009-0938-014 0938
             
        "End Stage Renal Disease Medical Evidence Report Medicare Entitlement and/or Patient Registration and Supporting Regulations in 42 CFR, 405.2133; PL 95-292; CFR Parts...."
             
          
        
This form captures the necessary medical information required to determine Medicare eligibility of an end state renal disease claimant. It also captures the specific medical data required for research and policy decisions on this population as required by law. 2014-02-28-05:00 Active William Parham 4107864669 No No No 100000 75000 0

End Stage Renal Disease Medical Evidence Report Medicare Entitlement and/or Patient Registration and Supporting Regulations in 42 CFR, 405.2133; PL 95-292; CFR Parts.... No Health Health Care Services
CMS-2728 END STAGE RENAL DISEASE MEDICAL EVIDENCE REPORT MEDICARE ENTITLEMENT AND/OR PATIENT REGISTRATION Yes Yes Fillable Fileable Form CMS_FORM-2728_Form.pdf Yes No Printable Only Instruction CMS_FORM-2728_Instructions.pdf
Individuals or Households 100000 75000 0

2010-10-29-04:00

0938-0050 201308-0938-011 0938
             
        "Hospitals and Health Care Complex Cost Report and Supporting Regulation in 42 CFR 413.20 and 413.24"
             
          
        
Form CMS 2552-10 is used by hospitals participating in the Medicare program to report the health care costs to determine the amount of reimbursable costs for services rendered to Medicare beneficiaries. 2016-09-30-04:00 Active William Parham 4107864669 No No No 6171 4153083 0

Hospitals and Health Care Complex Cost Report (CMS-2552-10) No Health Health Care Services
CMS-2552-10 Hospitals and Health Care Complex Cost Report Yes Yes Fillable Fileable Form and instruction pr2_40.pdf CMS-2552-10 Hospitals and Health Care Complex Cost Report Yes Yes Fillable Fileable Form and instruction R3P240F.pdf CMS-2552-10 Hospitals and Health Care Complex Cost Report Yes Yes Fillable Fileable Form and instruction R3P240S.pdf
Private Sector 6171 4153083 0

2013-09-20-04:00

0938-0065 201106-0938-020 0938
             
        "Outpatient Physical Therapy Speech Pathology Survey Report and Supporting Regulation in 42 CFR 485.701-485.729 (CMS-1893/1856)"
             
          
        
The Medicare Program surveys providers of outpatient physical therapy and sppech-language patholgy services to determine compliance with Federal Regulations. The request for certification form is used by State Agency surveyors to determine if minimum Medicare eligibility requirements are met. The survey report form records the result of the on-site survey. 2014-08-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 495 866 0

Outpatient Physical Therapy Speech Pathology Survey Report and Supporting Regulation in 42 CFR 485.701-485.729 No Health Health Care Services
CMS-1893 Outpatient Physical Therapy -- Speech Pathology Survey Report No No Fillable Printable Form and instruction Form CMS-1856.pdf CMS-1856 Request for Certification in the Medicare and/or Medicaid Program No No Fillable Printable Form and instruction Form CMS-1856.pdf
Private Sector 495 866 0

2011-08-10-04:00

0938-0067 201305-0938-020 0938
             
        "Quarterly Medicaid Statement of Expenditures for the Medical Assistance Program (CMS-64)"
             
          
        
The State Medicaid agencies use the Form CMS-64, Quarterly Medicaid Statement of Expenditures for the Medical Assistance Program to report their actual program benefit costs and administrative expenses to the Centers for Medicare and Medicaid Services (CMS). CMS uses this information to compute the Federal financial participation for the State's Medicaid Program costs. 2015-01-31-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 224 18144 0

Quarterly Medicaid Statement of Expenditures for the Medical Assistance Program No Health Health Care Services
CMS-64 Quarterly Medicaid Assistance Expenditures For the Medical Assistance Program Yes Yes Fillable Printable Form CMS 64 Forms.pdf
State, Local, and Tribal Governments 224 18144 0

2013-07-02-04:00

0938-0074 201202-0938-005 0938
             
        "Request for Certification as Rural Health Clinic Form and Supporting Regulations in 42 CFR 491.1-491.11"
             
          
        
The Form CMS-29 is utilized as an application to be completed by suppliers of RHC services requesting participation in the Medicare/Medicaid programs. This form initiates the process of obtaining a decision as to whether the conditions for certification are met as a supplier of RHC services. It also promotes data reduction or introduction to and retrieval from the Automated Survey Process Environment (ASPEN) and related survey and certification databases by the CMS Regional Offices. 2015-04-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 864 144 0

Verification of Clinic Data - Rural Health Clinic Program Form and Supporting Regulations in 42 CFR 491.1-491.11 No Health Health Care Services
CMS-29 Verification of Clinic Data - Rural Health Clinic Program No No Printable Only Form and instruction cms 29instructionsandForm508compliant.pdf
Private Sector 864 144 0

2012-04-10-04:00

0938-0101 201103-0938-009 0938
             
        "Medicaid Program Budget Report (CMS-37), and Supporting Regs."
             
          
        
The Medicaid Program Budget Report is prepared by the State Medicaid Agencies and is used by CMS for (1) developing National Medicaid Budget estimates, (2) qualification of Budget Estimate Changes, and (3) the issuance of quarterly Medicaid Grant Awards. 2014-04-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 224 7616 0

Medicaid Program Budget Report (CMS-37), and Supporting Regs. No Health Health Care Services
CMS-37 Medicaid Program Budget Report Yes Yes Fillable Fileable Form Screen Shots for CMS.37.docx
State, Local, and Tribal Governments 224 7616 0

2011-04-25-04:00

0938-0102 201105-0938-003 0938
             
        "Organ Procurement Organization/Histocompatibility Laboratory Statement of Reimbursable Costs,  manual instructions and supporting regulations contained in 42 CFR 413.20 and 413.24"
             
          
        
This form is required by statue and regulation for participation in the Medicare program. The information is used to determine payment for Medicare. Organ Procurement Organizations and Histocompatibility Laboratories are the users. 2014-07-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 115 5175 0

Organ Procurement Organization/Histcompatibility Laboratory Statement of Reimbursable Costs, Manual Instructions (CMS-216-94) No Health Health Care Services Private Sector 115 5175 0

2011-07-24-04:00

0938-0107 201106-0938-003 0938
             
        "Independent Rural Health Center/Freestanding Federally Qualified Health Center Cost Report and Supp. Regs in 42 CFR Sections 413.20 and 413.24"
             
          
        
The Form CMS-222-92 cost report is needed to determine program reimbursement and the amount of reasonable cost due to providers for furnishing medical services to Medicare beneficiaries. 2014-08-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 5812 290600 0

Independent Rural Health Center/Freestanding Federally Qualified Health Center Cost Report and Supp. Regs in 42 CFR Sections 413.20 and 413.24 (CMS-222-92) No Health Health Care Services
Yes Yes Paper Only Instruction pr2_2990_to_2995.doc Yes Yes Paper Only Instruction pr2_29_toc.doc Yes Yes Paper Only Instruction pr2_2900_to_2910.doc CMS-222-92 Independent Rural Health Clinic and Freestanding Federally Qualified Health Center Cost Report Yes Yes Paper Only Form R9p229f.xlsx
Private Sector 5812 290600 0

2011-08-11-04:00

0938-0146 201308-0938-027 0938
             
        "State Medicaid Eligibility Quality Control Sampling Plan"
             
          
        
State Title XIX agencies are required to submit sampling plan revisions 60 days prior to the corresponding review period and universe estimates and sampling intervals 2 weeks prior to the first selection of the review period. CMS or its contractors reviews the plans to ensure States are using valid statistical methods for sample selection. 2017-01-31-05:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 20 480 0

State Medicaid Eligibility Quality Control Sampling Plan No Health Health Care Services State, Local, and Tribal Governments 20 480 0

2014-01-23-05:00

0938-0147 201308-0938-028 0938
             
        "State Medicaid Eligibility Quality Control Sample Selection Lists and Supporting Regulations"
             
          
        
State Title XIX agencies are required to submit sample selection lists at the beginning of each month. The Regional Office staff review the lists to ensure States are sampling an adequate number of cases. 2016-10-31-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 120 960 0

State Medicaid Eligibility Quality Control Sample Selection Lists and Supporting Regulations at 42 CFR 431.800 - 431.865 No Health Health Care Services State, Local, and Tribal Governments 120 960 0

2013-10-23-04:00

0938-0151 201201-0938-005 0938
             
        "Laboratory Personnel Report (CLIA) and Supporting Regulations in 42 CFR 493.1 - 493.2001 (CMS-209)"
             
          
        
This form is used by the State agency to determine a laboratory's compliance with personnel qualifications under CLIA. This information is needed for a laboratory's CLIA certification and recertification. 2015-04-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 10500 5250 0

Laboratory Personnel Report (CLIA) and Supporting Regulations in 42 CFR 493.1 - 493.2001 No Health Health Care Services
CMS-209 Laboratory Personnel Report (CLIA) Yes No Fillable Printable Form and instruction CMS209.pdf
Private Sector 9645 4822 0

Laboratory Personnel Report (CLIA) and Supporting Regulations in 42 CFR 493.1-493.2001 (CMS-209) No Health Health Care Services
CMS-209 Laboratory Personnel Report (CLIA) Yes No Fillable Printable Form and instruction CMS209.pdf
State, Local, and Tribal Governments 810 405 0

Laboratory Personnel Report (CMS-209) No Health Health Care Services
CMS-209 Laboratory Personnel Report (CLIA) Yes No Fillable Printable Form and instruction CMS209.pdf
Federal Government 45 23 0

2012-04-10-04:00

0938-0165 201305-0938-010 0938
             
        "Prepaid Health Plan Cost Report"
             
          
        
These forms are needed to establish the reasonable cost of providing covered services to the enrolled Medicare population of an HMO/CMP/HCPP in accordance with Sections 1876 and 1833 of the Social Security Act. 2016-08-31-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 106 4372 0

Prepaid Health Plan Cost Report (HCPPS) No Health Health Care Services
CMS-276 Inventory-Cost Report Yes Yes Fillable Fileable Form Cost Report PRA Package Inventory vj508.pdf Yes No Fillable Fileable Instruction CostReportInstructionsFinal vj 508.pdf CMS-276 Budget Forecast Yes Yes Fillable Fileable Form Budget-Revised vj508.pdf CMS-276 Final Cost Report Yes No Fillable Fileable Form FinalCostReport-Revised vj508.pdf 276-99 Prepaid Health Plan Cost Report Worksheet Yes Yes Fillable Fileable Form interim(1) vj508.pdf
Private Sector 30 800 0

Prepaid Health Plan Cost Report (HMO) No Health Health Care Services
CMS-276 Budget Forecast Yes Yes Fillable Fileable Form Budget-Revised vj508.pdf CMS-276 Final Cost Report Yes Yes Fillable Fileable Form FinalCostReport-Revised vj508.pdf Yes No Fillable Printable Instruction CostReportInstructionsFinal vj 508.pdf CMS-276 4th Quarter Cost Report Yes Yes Fillable Fileable Form CMS-276.4th Quarter Report.xls CMS-276 Interim Report Yes Yes Fillable Printable Form interim(1) vj508.pdf
Private Sector 76 3572 0

2013-08-06-04:00

0938-0193 201305-0938-023 0938
             
        "State Plan Under Title XIX of the Social Security Act  (Base plan pages, Attachments, Supplements to Attachments)"
             
          
        
The Medicaid State base plan pages and attachments are documents utilized by State and territorial agencies which have the responsibility for administering the Medicaid program. The Medicaid State plan is comprised of "pages" and organized by subject matter which include Medicaid eligibility (Section 2), services (Section 3), payment for services (Section 4), and general, financial and personnel administration (Sections 1, 5, 6, 7). When States or territories seek to change selected pages of their State plans, the page(s) are transmitted to the Centers for Medicare & Medicaid Services (CMS) for review and approval by the CMS Central and Regional Offices prior to amending its State plan. Associated with the "CMS-179", a one page cover page that is included in every State plan amendment, the base State plan pages contain approximately 150 documents, and the Attachments and Supplements contain approximately 500 documents that correspond to implementing regulations in the CFR and statutes in the Social Security Act. The base and plan page documents have the same OMB approval number as the CMS-179. The present revision of the current collection is to revise and update selected pages to comply with Federal laws and regulations. 2015-07-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 1120 22400 0

State Plan Under Title XIX of the Social Security Act (Base plan pages) No Health Health Care Services
CMS-179 Transmittal and Notice of Approval of State Plan Material (e-version) Yes Yes Fillable Fileable Form and instruction CMS 179 Form (e-version).pdf
State, Local, and Tribal Governments 1120 22400 0

2013-05-30-04:00

0938-0202 201106-0938-005 0938
             
        "Home Office Cost Statement and Supporting Regulations in 42 CFR 413.17 and 413.20"
             
          
        
The Form CMS-287-05 is filed annually by Chain Home Offices to report the information necessary for the determination of Medicare reimbursement to components of chain organizations. 2014-08-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 1541 718106 0

Home Office Cost Statement and Supporting Regulations in 42 CFR 413.17 and 413.20 (CMS-287-05) No Health Health Care Services
Yes No Printable Only Instruction pr2_3900_to_3990.docx CMS-287-05 Home Office Cost Statement Yes No Printable Only Form 287-05.xls Yes No Printable Only Instruction pr2_39_toc.docx
Private Sector 1541 718106 0

2011-08-10-04:00

0938-0236 201110-0938-007 0938
             
        "Independent Renal Dialysis Facility Cost Report and Supporting Regulations 42 CFR 413.20 and 42 CFR 413.24"
             
          
        
The Independent Renal Dialysis Facility Cost Report provides for the determination and allocation of costs to the components of the facility in order to establish a proper basis for Medicare payment. 2014-11-30-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 5654 367510 0

Independent Renal Dialysis Facility Cost Report and Supporting Regulations 42 CFR 413.20, 42 CFR 413.24 and 42 CFR 413.178 No Health Health Care Services
Yes No Printable Only Instruction pr2_4295_to_4295 [rev 10-12-11].doc CMS-265-11 Independent Renal Dialysis Facility Cost Report Yes Yes Fillable Printable Form CMS-265-11 -- rev 10-12-11.xlsx Yes No Printable Only Instruction pr2_42_toc.doc Yes No Printable Only Instruction pr2_4200_to_4215 [rev 10-12-11].doc
Private Sector 5654 367510 0

2011-11-28-05:00

0938-0246 201308-0938-025 0938
             
        "Certification of Medicaid Eligibilty Quality Control (MEQC) Payment Error Rates and Supporting Regulations at 42 CFR.431.800 through 431.865"
             
          
        
State agencies are required to submit the Payment Error Rate form to their respective CMS Regional Offices. Regional Office staff will review these forms for completeness and will forward these forms to the Central Office for compilation of error rate charts for projected quarterly withholdings and/or fiscal disallowances. 2016-09-30-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 51 16446 0

Certification of Medicaid Eligibilty Quality Control (MEQC) Payment Error Rates and Supporting Regulations at 42 CFR.431.800 through 431.865 No Health Health Care Services
CMS-301 CMS-301.MEQC Annual Report Yes No Fillable Fileable Form and instruction CMS-301.MEQC Annual Report.DOC CMS-301 Certfication of Eligibility/Error Rate Yes No Fillable Fileable Form CMS-301 (2).pdf
State, Local, and Tribal Governments 51 16446 0

2013-09-26-04:00

0938-0251 201012-0938-021 0938
             
        "Application for Hospital Insurance "
             
          
        
The form CMS 18 (and 18SP) is used to establish entitlement to Hospital Insurance (Part A) and Supplementary Medical Insurance (Part B) by individuals who do not qualify for entitlement based upon entitlement to a Social Security or Railroad Retirement benefits. 2014-03-31-04:00 Active Bonnie Harkless 4107865666 No No No 50000 12495 0

Application for Hospital Insurance and Supporting Regulations in 42 CFR 406.6, 406.7,406.10,406.11 and 406.20 No Health Health Care Services
CMS-18F5 Application for Hospital Insurance Yes Yes Fillable Printable Form and instruction CMS-18F5(508) (2).pdf CMS-18F5SP SOLICITUD PARA EL SEGURO DE HOSPITAL Yes Yes Fillable Printable Form and instruction CMS-18F5 SP(508).pdf
Individuals or Households 50000 12495 0

2011-03-14-04:00

0938-0266 201106-0938-018 0938
             
        "Ambulatory Surgical Center (ASC) Health Insurance Benefits Agreement Form, Request for Certification, Survey Report  (CMS-377, 378, 370)"
             
          
        
The CMS-370 Health Insurance Benefits Agreement is utilized for the purpose of establishing eligibility for payment under Title XVIII of the Social Security Act. The CMS-377 ASC Request for Certification or Update of Certification Information in the Medicare Program form as revised will be utilized to collect facility-specific characteristics that facilitate CMS' oversight of ASCs, for example, through the ability to track and trend survey results broken down by various facility characteristics. The data also enables CMS to respond to inquiries from the Congress, GAO, OIG concerning the characteristics of Medicare-participating ASCs. The data base that supports survey and certification activities will be revised to reflect changes in the data fields on this revised form, such as the data on the types of surgical procedures performed in the ASC. This form is submitted by ASCs when they request initial certification of compliance with the ASC CfCs or to update an ASC's existing certification information. The CMS-378 is being discontinued. 2014-09-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 2090 647 0

Ambulatory Surgical Center (ASC) Health Insurance Benefits Agreement Form, Request for Certification, Survey Report No Health Health Care Services
CMS-370 Ambulatory Surgical Center (ASC) Health Insurance Benefits Agreement Yes No Paper Only Form CMS370.pdf CMS-377 Ambulatory Surgical Center (ASC) Request for Initial Certification or Update of Certification Information in the Medicare Program Yes No Paper Only Form and instruction CMS377.revised.111610.additional revisions.docx
Private Sector 2090 647 0

2011-09-05-04:00

0938-0267 201209-0938-005 0938
             
        "Comprehensive Outpatient Rehabilitation Facility (CORF) Eligibility and Survey Forms and Information Collection Requirements in 42 CFR 485.56, 485.58, 485.60, 485.64... (CMS-359/360)"
             
          
        
In order to participate in the Medicare program as a CORF, providers must meet federal conditions of participation. The certification form is needed to determine if providers meet at least preliminary requirements. The survey form is used to record provider compliance with the individual conditions and report findings to CMS. 2016-03-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 42 137 0

Comprehensive Outpatient Rehabilitation Facility (CORF) Eligibility and Survey Forms and Information Collection Requirements in 42 CFR 485.56, 485.58, 485.60, 485.64... No Health Health Care Services
CMS-360 CORF Survey Report Yes No Fillable Printable Form CMS-360.pdf CMS-359 CORF Request for Certification to Participate in the Medicare Program Yes No Fillable Printable Form and instruction CMS-359 [rev 09-18-2012].pdf
State, Local, and Tribal Governments 42 137 0

2013-03-20-04:00

0938-0269 201110-0938-008 0938
             
        "Request for Accelerated Payments Supporting Regs in 42 CFR, section 412.116(f), 412.632(e), 413.64(g), 413.350(d) & 484.245"
             
          
        
These forms are used by fiscal intermediaries to assess a provider's eligibility for accelerated payments. Such a payment is granted if there is an unusual delay in processing bills. 2014-12-31-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 945 473 0

Request for Accelerated Payments Supporting Regs in 42 CFR, section 412.116(f), 412.632(e), 413.64(g), 413.350(d) & 484.245 No Health Health Care Services Private Sector 945 473 0

2011-12-12-05:00

0938-0272 201204-0938-003 0938
             
        "Annual Report on Home and Community-based Services Waivers (CMS-372)"
             
          
        
States with an approved waiver under section 1915 (c) of the act are required to submit a report annually in order for CMS to: (1) Verify that State assurances regarding waiver cost-neutrality are met, and (2) determine the waiver's impact on the type, amount, and cost of services provided under the State Plan and health welfare of recipients. 2015-06-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 305 13115 0

Annual Report on Home and Community-based Services Waivers No Health Health Care Services
CMS-372 Annual Report on Home and Community Based Waivers Yes Yes Fillable Fileable Form and instruction Blank 372 Screenshots.doc
State, Local, and Tribal Governments 305 13115 0

2012-06-08-04:00

0938-0273 201106-0938-019 0938
             
        "Identification of Extension Units of Outpatient Physical Therapy/Outpatient Speech Pathology Providers and Support Regs. (CMS-381)"
             
          
        
Medicare provides OPT/OSP providers to be surveyed to determine compliance with Federal Regulations. All locations where OPT/OSP providers furnish services must meet these requirements. The CMS-381 is the form used to identify all the OPT/OSP locations. 2014-08-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 2960 740 0

Identification of Extension Units of Outpatient Physical Therapy/Outpatient Speech Pathology Providers and Support Regs. (CMS-381) No Health Health Care Services
CMS-381 Model Letter Requesting Identification of Extension Locations No No Fillable Printable Form and instruction Form CMS-381.pdf
Private Sector 2960 740 0

2011-08-11-04:00

0938-0287 201105-0938-001 0938
             
        "Withholding Medicare Payments to Recover Medicaid Overpayments and Supporting Regulations in 42 CFR 447.31 (CMS-R-21)"
             
          
        
Overpayments may occur in either the Medicare and Medicaid program, at times resulting in a situation where an institution or person that provides services owes a repayment to one program while still receiving reimbursement from the other. Certain Medicaid providers which are subject to offsets for the collection of Medicaid overpayments may terminate or substantially reduce their participation in Medicaid, leaving the State Medicaid Agency unable to recover the amounts due. These information collection requirements give CMS the authority to recover Medicaid overpayments by offsetting payments due to a provider under the program. 2014-08-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 27 81 0

Withholding Medicare Payments to Recover Medicaid Overpayments and Supporting Regulations in 42 CFR 447.31 No Health Health Care Services State, Local, and Tribal Governments 27 81 0

2011-08-11-04:00

0938-0301 201305-0938-011 0938
             
        "Medicare Provider Cost Report Reimbursement Questionnaire and Supporting Regulations in 42 CFR 413.20, 413.24, and 415.60"
             
          
        
Form CMS-339 assists providers in the preparation of an acceptable cost report and minimizes subsequent contact between the providers and their intermediaries. Form CMS-339 provides the data necessary to support the information in cost reports. This includes information the providers use to develop the provider and professional components of physician compensation so that compensation can be properly allocated between the Part A and the Part B trust funds. CMS is seeking approval of the attached, revised of Form CMS-339. 2016-09-30-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 23391 75625 0

Medicare Provider Cost Report Reimbursement Questionnaire (exhibit 1) No Health Health Care Services
CMS-276 Exhibits 1&2 Yes Yes Fillable Fileable Form Form-CMS-339 Exhibits 2012.pdf CMS-339 Medicare Provider Cost Report Reimbursement Questionnaire Yes Yes Fillable Fileable Form and instruction cms339[1].pdf
Private Sector 17939 53817 0

Medicare Provider Cost Report Reimbursement Questionnaire (exhibit 2 --formerly exhibit 5) No Health Health Care Services
CMS-276 Index and Instruction Yes No Printable Only Form and instruction Form CMS-339 Index 2012.pdf Yes No Printable Only Instruction Form CMS 339 Instructions 2012.pdf CMS-276 Exhibits Yes Yes Fillable Fileable Form Form-CMS-339 Exhibits 2012.pdf CMS-339 Medicare Provider Cost Report Reimbursement Questionnaire Yes Yes Fillable Fileable Form and instruction cms339[1].pdf CMS-276 Manual Yes Yes Fillable Printable Form and instruction Form CMS-339 Transmittal 7. doc.pdf
Private Sector 5452 21808 0

Medicare Provider Cost Report Reimbursement Questionnaire (exhibits 5) No Health Health Care Services
CMS-339 Medicare Provider Cost Report Reimbursement Questionnaire Yes Yes Fillable Fileable Form and instruction cms339[1].pdf
Private Sector 0 0 0

Medicare Provider Cost Report Reimbursement Questionnaire (exhibits 6) No Health Health Care Services
CMS-339 Medicare Provider Cost Report Reimbursement Questionnaire Yes Yes Fillable Fileable Form and instruction cms339[1].pdf
Private Sector 0 0 0

2013-09-26-04:00

0938-0313 201012-0938-011 0938
             
        "Hospice Request for Certification in the Medicare Program and Supporting Regulations contained in 42 CFR Part 489.11 and 489.20"
             
          
        
The Hospice Request for Certification Form is the identification and screening form used to initiate the certification process and to determine if the provider has sufficient personnel to participate in the Medicare program. 2014-02-28-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 3494 874 0

Hospice Request for Certification in the Medicare Program and Supporting Regulations contained in 42 CFR Part 489.11 and 489.20 No Health Health Care Services
CMS-417 Hospice Request for Certification in the Medicare Program No No Paper Only Form and instruction CMS-417-r.pdf
Private Sector 3494 874 0

2011-01-17-05:00

0938-0328 201011-0938-003 0938
             
        "Hospital Conditions of Participation (COP) and Supporting Regulations in 42 CFR, Sections 482.12, 482.13, 482.21, 482.22, 482.27, 482.30, 482.41, 482.43, 482.45, 482.53....."
             
          
        
This information collection package is a request for an revision of the currently approved information collection requirements under CMS-R-48 (0938-0328). We have updated the burden estimates associated with the current hospital conditions of participation (CoPs) to include informaiton collection requirement contained in 42 CFR 482.13(h). 2014-03-31-04:00 Active William Parham 4107864669 No No No 41367340 9147427 0

42CFR482.12(d)(1-2) and (d)(4) No Health Health Care Services Private Sector 4991 31194 0

42CFR482.12(e)(2) No Health Health Care Services Private Sector 4991 2496 0

42CFR482.12(f)(2) No Health Health Care Services Private Sector 300 75 0

42CFR482.13(a)(1-2) No Health Health Care Services Private Sector 37277779 3190927 0

42CFR482.13(f) No Health Health Care Services Private Sector 998 4550880 0

42CFR482.13(g) No Health Health Care Services Private Sector 1000 250 0

42CFR482.21(a)(b)(d) No Health Health Care Services Private Sector 4991 908362 0

42CFR482.27(b)(2) No Health Health Care Services Private Sector 4991 8734 0

42CFR482.27(c) No Health Health Care Services Private Sector 4991 1 0

42CFR482.43 No Health Health Care Services Private Sector 3300199 274907 0

42CFR482.45(a)(1) No Health Health Care Services Private Sector 752000 62642 0

42CFR482.45(a)(1) No Health Health Care Services Private Sector 4991 1 0

42CFR482.45(b)(3) No Health Health Care Services Private Sector 258 115743 0

42 CFR 482.13(h) No Health Health Care Services Private Sector 4860 1215 0

2011-03-14-04:00

0938-0338 201307-0938-019 0938
             
        "Conditions of Participation for Portable X-ray Suppliers and Supporting Regulations in 42 CFR Sections 486.104, 486.106, 486.110"
             
          
        
The information is required to certify portable X-ray suppliers wishing to participate in the Medicare program. The information collection is needed to determine if portable X-ray suppliers are in compliance with published health and safety requirements. This is standard medical practice and is necessary in order to ensure the well-being and safety of patients and professional treatment accountability. 2016-08-31-04:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 1734 948 0

Conditions of Participation for Portable X-ray Suppliers and Supporting Regulations in 42 CFR Section 486.104 No Health Health Care Services Private Sector 578 289 0

Conditions of Participation for Portable X-ray Suppliers and Supporting Regulations in 42 CFR Section 486.106 No Health Health Care Services Private Sector 578 578 0

Conditions of Participation for Portable X-ray Suppliers and Supporting Regulations in 42 CFR Section 486.110 No Health Health Care Services Private Sector 578 81 0

2013-08-23-04:00

0938-0345 201301-0938-002 0938
             
        "Medicaid Statistical Information System (MSIS) and the Transformed - Medicaid Statistical Information System (T-MSIS)"
             
          
        
State data are reported by the federally mandated electronic process, known as MSIS is currently collecting eligibility and claim data in 5 separate files. These data are the basis of actuarial forecasts for Medicaid service utilization and costs; of analysis and cost savings estimates required for legislative initiatives relating to Medicaid and for responding to requests for information from CMS components, the Department, Congress and other customers. The expanded version of MSIS is now referred to as TMSIS will incorporate 3 additional files (Provider, Managed Care Plans, and Third Party Liability). 2016-04-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 816 8160 0

Medicaid Statistical Information System (MSIS) No Health Health Care Services State, Local, and Tribal Governments 204 2040 0

Transformed - Medicaid Statistical Information System (T-MSIS) No Health Health Care Services State, Local, and Tribal Governments 612 6120 0

2013-04-23-04:00

0938-0354 201312-0938-009 0938
             
        "Annual Early and Periodic Screening, Diagnostic and Treatment Services (EPSDT) Participation Report (CMS-416)"
             
          
        
States are required to submit an annual report on the provision of EPSDT services to CMS pursuant to section 1902(a)(43)(D) of the Social Security Act. These reports provide CMS with data necessary to assess the effectiveness of State EPSDT programs, to determine a state's results in achieving its participation goal, and to respond to inquiries. Respondents are State Medicaid agencies. The data is due April 1 of every year so States need to have the form and instructions as soon as possible in order to report timely. 2017-02-28-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 56 1568 0

Annual Early and Periodic Screening, Diagnostic and Treatment Services (EPSDT) Participation Report No Health Health Care Services
CMS-416 Annual EPSDT Participation Report Yes Yes Fillable Printable Form CMS_416_2010_508.pdf Yes No Printable Only Instruction 416 instructions revised per 60-day public comments.pdf
State, Local, and Tribal Governments 56 1568 0

2014-02-06-05:00

0938-0358 201102-0938-011 0938
             
        "Psychiatric Unit Criteria Work Sheet and Supporting Regulations in 42 CFR 412.25 and 412.27 (CMS-437)"
             
          
        
The psychiatric unit criteria worksheet is necessary to verify that these units comply and remain in compliance with the exclusion criteria for the Medicare prospective payment system. 2014-04-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 1333 333 0

Psychiatric Unit Criteria Work Sheet, Rehabilitation Unit Criteria Work Sheet and Rehabilitation Hospital Criteria Work Sheet, and Supporting Regulations at 42 CFR 488.26 No Health Health Care Services
CMS-437 Psychiatric Unit Criteria Worksheet No No Paper Only Form and instruction CMS-437 form & guidance.tif
Private Sector 1333 333 0

2011-04-11-04:00

0938-0373 201307-0938-001 0938
             
        "Medicare Participating Physician or Supplier Agreement"
             
          
        
The CMS-460 is completed by nonparticipating physicians and suppliers if they choose to participate in Medicare Part B. By signing the agreement, the physician or supplier agrees to take assignment on all Medicare claims. To take assignment means to accept the Medicare allowed amount as payment in full for the services they furnish and to charge the beneficiary no more than the deductible and coinsurance for the covered service. In exchange for signing the agreement, the physician or supplier receives a signficiant number of program benefits not available to nonparticipating suppliers. The information associated with this collection is needed to identify the recipients of the program benefits. 2016-07-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 120000 30000 0

Medicare Participating Physician or Supplier Agreement No Health Health Care Services
CMS-460 Medicare Participating Physician or Supplier Agreement Yes No Fillable Fileable Form and instruction CMS-460.pdf
Private Sector 120000 30000 0

2013-07-26-04:00

0938-0379 201207-0938-003 0938
             
        "Hospice Survey and Deficiencies Report Form (CMS-643)"
             
          
        
In order to participate in the Medicare program, a hospice must meet certain Federal health and safety conditions of participation. This form will be used by State surveyors to record data about a hospice's compliance with these conditions of participation in order to initiate the certification or recertification process. 2015-09-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 1217 1217 0

Hospice Survey and Deficiencies Report Form (CMS-643) No Health Health Care Services
CMS-643 Hospice Survey and Deficiencies Report Yes No Fillable Printable Form CMS-643 [rev 7-18-2012].pdf
State, Local, and Tribal Governments 1217 1217 0

2012-09-18-04:00

0938-0391 201209-0938-007 0938
             
        "Statement of Deficiencies and Plan of Correction (CMS-2567)"
             
          
        
This Paperwork package provides information regarding the form used by the Medicare, Medicaid, and the Clinical Laboratory Improvement Amendments (CLIA) programs to document a health care facility's compliance or noncompliance (deficiencies) with regard to the Medicare/Medicaid Conditions of Participation and Coverage, the requirements for participation for Skilled Nursing Facilities and Nursing Facilities, and for certification under CLIA. This form becomes the evidentiary basis for CMS certification decisions (including termination or denial of participation), and the form of public disclosure. 2015-12-31-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 62000 134333 0

Statement of Deficiencies and Plan of Correction No Health Health Care Services
CMS-2567 Statement of Deficiencies and Plan of Correction Yes No Fillable Printable Form and instruction CMS2567-508.pdf
Private Sector 62000 134333 0

2012-12-20-05:00

0938-0426 201308-0938-020 0938
             
        "ICR Req's in HSQ-110, Acquisition, Protection and Disclosure of PRO Information and Supporting Regulations in 42 CFR 480.104, 480.105, 480.116, 480.134"
             
          
        
The Peer Review Improvement Act of 1982 authorizes quality improvement organizations (QIOs), formerly known as PROs, to acquire information necessary to fulfill their duties and functions and places limits on disclosure of the information. These requirements are on the QIOs to provide notices to the affected parties when disclosing information about them. These reqirements serve to protect the rights of the affected parties. 2016-09-30-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 5228 60660 0

ICR Req's in HSQ-110, Acquisition, Protection and Disclosure of PRO Information and Supporting Regulations in 42 CFR 476.104, 476.105, 476.116, 476.134 No Health Health Care Services Private Sector 5228 60660 0

2013-09-20-04:00

0938-0443 201308-0938-017 0938
             
        "Information Collection Requirements in 42 CFR 473.18, 473.34, 473.36, and 473.42, PRO Reconsiderations and Appeals"
             
          
        
These regulations contain procedures for QIOs (formerly known as PROs) to use in reconsideration of initial determinations. The information requirements contained in these regulations are on QIOs to provide information to parties requesting a reconsideration. These parties will use the information as guidelines for appeal rights in instances where issues are still in dispute. 2016-09-30-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 7584 2822 0

Information Collection Requirements in 42 CFR 473.18, 473.34, 473.36, and 473.42, PRO Reconsiderations and Appeals No Health Health Care Services Individuals or Households 2414 1207 0

Information Collection Requirements in 42 CFR 473.18, 473.34, 473.36, and 473.42, PRO Reconsiderations and Appeals No Health Health Care Services Individuals or Households 2414 1207 0

Information Collection Requirements in 42 CFR 473.18, 473.34, 473.36, and 473.42, PRO Reconsiderations and Appeals No Health Health Care Services Individuals or Households 2414 201 0

Information Collection Requirements in 42 CFR 473.18, 473.34, 473.36, and 473.42, PRO Reconsiderations and Appeals No Health Health Care Services Individuals or Households 300 200 0

Information Collection Requirements in 42 CFR 473.18, 473.34, 473.36, and 473.42, PRO Reconsiderations and Appeals No Health Health Care Services Individuals or Households 42 7 0

2013-09-20-04:00

0938-0445 201311-0938-029 0938
             
        "QIO Assumption of Responsibilities and Supporting Regulations"
             
          
        
The Peer Review Improvement Act of 1982 amended Title XI of the Social Security Act to create the Utilization and Quality Control Peer Review Organization (PRO) program which replaces the Professional Standards Review Organization (PSRO) program and streamlines peer review activities. The term PRO has been renamed quality Improvement Organization (QIO). This collection describes the review functions to be performed by the QIO. It outlines relationships among QIOs, providers, practitioners, beneficiaries, intermediaries, and carriers. 2017-02-28-05:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 56377 100065 0

QIO Assumption of Responsibilities and Supp. Regs. in 42 CFR Sections 412.44 No Health Health Care Services Private Sector 6939 23130 0

QIO Assumption of Responsibilities and Supp. Regs. in 42 CFR Sections 412.46 (QIO Burden) No Health Health Care Services Private Sector 0 0 0

QIO Assumption of Responsibilities and Supp. Regs. in 42 CFR Sections 412.46 No Health Health Care Services Private Sector 23444 60072 0

QIO Assumption of Responsibilities and Supp. Regs. in 42 CFR Sections 476.71 No Health Health Care Services Private Sector 12000 15000 0

QIO Assumption of Responsibilities and Supp. Regs. in 42 CFR Sections 476.71 (FI Burden) No Health Health Care Services Private Sector 0 0 0

QIO Assumption of Responsibilities and Supp. Regs. in 42 CFR Sections 476.73(b)(1) No Health Health Care Services Private Sector 6939 619 0

QIO Assumption of Responsibilities and Supp. Regs. in 42 CFR Sections 476.73(b)(2) No Health Health Care Services Private Sector 5 20 0

QIO Assumption of Responsibilities and Supp. Regs. in 42 CFR Sections 476.74(b) No Health Health Care Services Private Sector 58 14 0

QIO Assumption of Responsibilities and Supp. Regs. in 42 CFR Sections 476.74(c) No Health Health Care Services Private Sector 53 53 0

QIO Assumption of Responsibilities and Supp. Regs. in 42 CFR Sections 476.78(b)(3) No Health Health Care Services Private Sector 6939 1157 0

2014-02-12-05:00

0938-0447 201308-0938-023 0938
             
        "End Stage Renal Disease Medical Information System ESRD Facility Survey and Supporting Regulations in 42 CFR 405.2133"
             
          
        
The ESRD Facility Survey form (CMS-2744) is completed annually by Medicare-approved providers of dialysis and transplant services. The CMS-2744 is designed to collect information concerning treatment trends utilization of services and patterns of practice in treating ESRD patients. 2016-12-31-05:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 5964 47712 0

End Stage Renal Disease Medical Information System ESRD Facility Survey and Supporting Regulations in 42 CFR 405.2133 No Health Health Care Services
CMS-2744 ESRD Facility Survey Instructions for Completion Yes No Printable Only Instruction CMS-2744.Current facility survey instructions.pdf CMS-2744A End Stage Renal Disease Medical Information System ESRD Facility Survey (Dialysis Units Only) Yes No Printable Only Form CMS-2744A.pdf CMS-2744B End Stage Renal Disease Medical Information System ESRD Facility Survey (Transplant Centers Only) Yes No Printable Only Form CMS-2744B.pdf
Private Sector 5964 47712 0

2013-12-13-05:00

0938-0448 201007-0938-015 0938
             
        "End Stage Renal Disease Death Notification, P.L. 95-292; 42 CFR 405.2133; 45 CFR 5,5b; 20 CFR Parts 401, 422E"
             
          
        
The ESRD Death Notification is to be completed upon the death of ESRD patients. Its primary purpose is to collect facts and cause of death. Reports of deaths are used to show cause of death and demographic characteristics of these patients. 2014-02-28-05:00 Active William Parham 4107864669 No No No 82768 41384 0

End Stage Renal Disease Death Notification, P.L. 95-292; 42 CFR 405.2133; 45 CFR 5,5b; 20 CFR Parts 401, 422E No Health Health Care Services
CMS-2746 ESRD Death Notification Yes No Printable Only Form and instruction CMS2746.pdf
Private Sector 82768 41384 0

2010-10-18-04:00

0938-0449 201309-0938-006 0938
             
        "Home & Community Based Waiver Requests and Supporting Regulations; 42 CFR 440.180, 441.300-.310 (CMS-8003)"
             
          
        
Under a Secretarial waiver, States may offer a wide array of home and community-based services to individuals who would otherwise require institutionalization. States requesting a waiver must provide certain assurances, documentation and cost & utilization estimates which are reviewed, approved and maintained for the purpose of identifying/verifying States' compliance with such statutory and regulatory requirements. 2017-01-31-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 71 6005 0

Home & Community Based Waiver Requests and Supporting Regulations; 42 CFR 440.180, 441.300-.310 No Health Health Care Services
CMS-8003 Application for a sec. 1915(c) Home and Community-Based Services Waiver Yes Yes Fillable Fileable Form and instruction Application for 1915(c) HCBS Waiver Draft GU_11_00_00.mht
State, Local, and Tribal Governments 71 6005 0

2014-01-27-05:00

0938-0454 201306-0938-005 0938
             
        "Physician Certifications/Recertifications in Skilled Nursing Facilities Manual Instructions and Supporting Regs."
             
          
        
Medicare, Skilled Nursing Facilities. 42 CFR 424.20 requires SNFs to keep record of physician certifications and recertification of information such as the need for care and services, estimated duration of the SNF stay, and plan for home care. 2016-09-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 2779694 641645 0

Physician Certifications/Recertifications No Health Health Care Services Private Sector 1796502 559713 0

Physician Initial Certification No Health Health Care Services Private Sector 983192 81932 0

2013-09-26-04:00

0938-0456 201305-0938-009 0938
             
        "Indirect Medical Education (IME) and Supporting Regulations 42 CFR 412.105"
             
          
        
The collection of information on interns and residents (IR) is needed to properly calculate Medicare program payments to hospitals that incur indirect costs for medical education. The agency's Intern and Resident Information System and similar contractor systems use the information for producing reports of duplicate full-time equivalent IR counts for IME. The contractors also use this information to ensure that hospitals are properly reimbursed for IME, and help eliminate duplicate reporting of IR counts which inflate payments. 2016-09-30-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 1190 2380 0

Indirect Medical Education (IME) and Supporting Regulations 42 CFR 412.105 No Health Health Care Services Private Sector 1190 2380 0

2013-09-20-04:00

0938-0463 201107-0938-006 0938
             
        "Skilled Nursing Facility and Skilled Nursing Facility Cost Report and Supporting Regulations in 42 CFR 413.20, 413.24, and 413.106"
             
          
        
Form CMS 2540-10 is used by Skilled Nursing Facilities (SNFs) and Skilled Nursing Facility Complexes participating in the Medicare program to report the health care costs to determine the amount of reimbursable costs for services rendered to Medicare beneficiaries. 2014-10-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 15701 3171602 0

Skilled Nursing Facility and Silled Nursing Facility Cost Report and Supporting Regulations in 42 CFR 413.20, 413.24, and 413.106 No Health Health Care Services
CMS-2540-10 Skilled Nursing Facility and Skilled Nursing Facility Health Care Complex Cost Report Certification and Settlement Summary Yes Yes Fillable Fileable Form CMS-2540-10 FORMS.xls Yes No Printable Only Instruction pr2_4195.doc Yes No Printable Only Instruction pr2_4121_to_4130.2.doc Yes No Printable Only Instruction pr2_4100_to_4107 [rev 07-13-11].doc Yes No Printable Only Instruction pr2_41_toc.doc Yes No Printable Only Instruction pr2_4190.doc Yes No Printable Only Instruction pr2_4131_to_4161.doc Yes No Printable Only Instruction pr2_4108_to_4120.doc
Private Sector 15701 3171602 0

2011-10-23-04:00

0938-0467 201203-0938-013 0938
             
        "Income and Eligibility Verification System Reporting and Supporting Regs. (CMS-R-0074)"
             
          
        
This collection is necessary to verify income and eligibility requirements for Medicaid recipients, as required by Section 1137 of the Social Security Act. 2015-07-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 71 134865 0

Income and Eligibility Verification System Reporting and Supporting Regs. No Health Health Care Services State, Local, and Tribal Governments 71 134865 0

2012-07-26-04:00

0938-0469 201301-0938-001 0938
             
        "The Fiscal Soundness Reporting Requirements"
             
          
        
The information in this collection will be used by the financial review team in order to establish that the MAOs, PDPs, PACE Organizations, 1876 Cost Plans and Demonstration Plans are maintaining fiscally sound organizations. 2016-06-30-04:00 Active William Parham 4107864669 No No No 1281 428 0

The Fiscal Soundness Reporting Requirements (CMS-906) No Health Health Care Services
CMS-906 Fiscal Soundness-Submission of Financial information page-PRA Yes Yes Fillable Fileable Form and instruction Fiscal Soundness-Submission of Financial information page-PRA.docx CMS-906 Submission_page No No Fillable Fileable Form and instruction CMS-906_Fiscal_Soundness_Reporting_Requirements_Submission_page.pdf
Private Sector 1281 428 0

2013-06-10-04:00

0938-0512 201304-0938-005 0938
             
        "Organ Procurement Organization's Health Insurance Benefits Agreement and Supporting Regulations 42 CFR 486.301-486.348 (CMS-576A)"
             
          
        
The information provided on this form serves as a basis for continuing the agreements with CMS and the 58 OPOs for participation in the Medicare and Medicaid programs and for reimbursement of service. 2016-06-30-04:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 58 116 0

Organ Procurement Organization's Health Insurance Benefits Agreement and Supporting Regulations 42 CFR 486.301-486.348 No Health Health Care Services
CMS-576A Health Insurance Benefits Agreement No No Paper Only Form CMS-576A.pdf
Private Sector 58 116 0

2013-06-10-04:00

0938-0534 201303-0938-014 0938
             
        "Attending Physician's Certification of Medical Necessity for Home Oxygen Therapy and Supporting Regulations 42 CFR 410.38 and 42 CFR 424.5"
             
          
        
This form is used to determine of oxygen is reasonable and necessary pursuant to Medicare Statute, Medicare claims for home oxygen therapy must be supported by the treating physician's statement and other information including estimate length of need (#of months), diagnosis codes (ICD-9) etc. 2016-06-30-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 1632000 326500 0

Attending Physician's Certification of Medical Necessity for Home Oxygen Therapy and Supporting Regulations 42 CFR 410.38 and 42 CFR 424.5 No Health Health Care Services
CMS-484 Certificate of Medical Necessity CMS-484 Oxygen Yes No Fillable Fileable Form and instruction cms484.pdf
Private Sector 1632000 326500 0

2013-06-10-04:00

0938-0544 201204-0938-007 0938
             
        "Survey Report Form Clinical Laboratory Improvement Amendments (CLIA) and supporting regulations in 42 CFR 493.1-493.2001"
             
          
        
This survey form is an instrument used by the State agency to record data collected in order to determine compliance with CLIA. This information is needed for laboratory certification and recertification. 2015-06-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 10244 5123 0

Private Sector - Survey Report Form Clinical Laboratory Improvement Amendments (CLIA) and supporting regulations in 42 CFR 493.1-493.2001 No Health Health Care Services
CMS-1557 Survey Report Form (CLIA) Yes No Fillable Fileable Form and instruction cms1557.pdf
Private Sector 9556 4778 0

State, Local, or Tribal Governments - Survey Report Form Clinical Laboratory Improvement Amendments (CLIA) and supporting regulations in 42 CFR 493.1-493.2001 No Health Health Care Services
CMS-1557 Survey Report Form (CLIA) Yes No Fillable Fileable Form and instruction cms1557.pdf
State, Local, and Tribal Governments 645 323 0

Federal Government - Survey Report Form Clinical Laboratory Improvement Amendments (CLIA) and supporting regulations in 42 CFR 493.1-493.2001 No Health Health Care Services
CMS-1557 Survey Report Form (CLIA) Yes No Fillable Fileable Form and instruction cms1557.pdf
Federal Government 43 22 0

2012-06-08-04:00

0938-0566 201303-0938-005 0938
             
        "Advance Beneficiary Notice of Noncoverage (ABN) and Supporting Regulations in 42 CFR 411.404 and 411.408"
             
          
        
The use of written notices to inform beneficiaries of their liability under specific conditions has been available since Title XVIII of the Social Security Act (the Act), section 1879, Limitation On Liability, was enacted in 1972 (P.L. 92-603). Similar required notification and liability protections are available under other sections of the Act: section 1834(a)(18) refund requirements for certain items when unsolicited telephone contacts are made, section 1834(j)(4) for the same types of items when there is neither a required advance coverage determination nor required supplier number; 1834(a)(15) also for advance determinations for these items and section 1842(l) applicable to physicians not accepting assignment. Implementing regulations are found at 42 CFR 411.404(b) and (c), and 411.408(d)(2) and (f), on written notice requirements. These statutory requirements apply only to Original Medicare, not Medicare Advantage plans. Under section 1879 of the Act, Medicare beneficiaries may be held financially responsible for items or services usually covered under Medicare, but denied in an individual case under specific statutory exclusions, if the beneficiary is informed prior to furnishing the issues or services that Medicare is likely to deny payment. When required, the ABN is delivered by Part B paid physicians, providers (including institutional providers like outpatient hospitals) practitioners (such as chiropractors), and suppliers, as well as hospice providers and Religious Non-medical Health Care Institutions paid under Part A. Other Medicare institutional providers paid under Part A use other approved notice for this purpose. 2016-06-30-04:00 Active William Parham 4107864669 No No No 52967771 6177101 0

Advance Beneficiary Notice of Noncoverage (ABN) and Supporting Regulations in 42 CFR 411.404 and 411.408 No Health Health Care Services
Yes No Printable Only Instruction ABNForminstructions2012v508.pdf CMS-R-131 Spanish ABN Yes No Fillable Fileable Form 508spanishabncorrected.pdf CMS-R-131 ABN Yes No Fillable Fileable Form 508ABN.pdf
Private Sector 52967771 6177101 0

2013-06-10-04:00

0938-0568 201202-0938-008 0938
             
        "Medicare Current Beneficiary Survey (MCBS)"
             
          
        
The Medicare Current Beneficiary Survey (MCBS) is a continuous, multipurpose survey of a nationally representative sample of aged, disabled, and institutionalized Medicare beneficiaries. MCBS, which is sponsored by the Centers for Medicare & Medicaid Services (CMS), is the only comprehensive source of information on the health status, health care use and expenditures, health insurance coverage, and socioeconomic and demographic characteristics of the entire spectrum of Medicare beneficiaries. The core of the MCBS is a series of interviews with a stratified random sample of the Medicare population, including aged and disabled enrollees, residing in the community or in institutions. Questions are asked about enrollees' patterns of health care use, charges, insurance coverage, and payments over time. Respondents are asked about their sources of health care coverage and payment, their demographic characteristics, their health and work history, and their family living circumstances. In addition to collecting information through the core questionnaire, the MCBS collects information on special topics through supplements. For example, questions are asked about enrollees' income and assets, access to health care, health and functional status and satisfaction with care. Special supplements also focus on emerging trends in health care. 2014-02-28-05:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 48651 58450 0

Medicare Current Beneficiary Survey (MCBS):(CMS Number CMS-P-0015A) No Health Health Care Services Individuals or Households 48651 58450 0

2012-03-13-04:00

0938-0573 201312-0938-014 0938
             
        "Medicare Geographic Classification Review Board Procedures and Criteria and Supporting Regulations in 42 CFR, Section 412.256"
             
          
        
Section 1886(d)(10) of the Social Security Act established the Medicare Geographic Classification Review Board (MGCRB), an entity with the authority to accept short-term hospital inpatient prospective payment system applications from hospitals requesting geographic reclassification for wage index or standardized amount payment purposes and issue decisions on these requests. This regulation sets up the application process for prospective payment system hospitals that choose to appeal their geographic status to the MGCRB. 2017-02-28-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 300 300 0

Medicare Geographic Classification Review Board (MGCRB) Procedures and Criteria and Supporting Regulations in 42 CFR, Section 412.256 & 412.230 (CMS-R-138) No Health Health Care Services Private Sector 300 300 0

2014-02-06-05:00

0938-0578 201308-0938-021 0938
             
        "Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534 (CMS-367)"
             
          
        
Section 1927 requires drug manufactures to enter into and have in effect a rebate agreement with the Federal Government for States to receive funding for drugs dispensed to Medicaid recipients. In order for payment to be made under Medicaid, the drug labeler must complete and sign a drug rebate agreement and fillin the information on the related documents. The Affordable Care Act (ACA) added two new data elements to potentially be reported by manufacturers, a Pediatric Exclusivity product indicator and a new optional "ACA base AMP" field. Additionally, per the ACA, the Federal upper limit (FUL) will be calculated as no less than 175 percent of the weighted average of the most recently reported monthly AMP. Section 1927 of the Act requires manufacturers to report the total number of units that are used to calculate monthly AMP for each covered outpatient drug no later than 30 days after the last day of the month. We plan to require manufacturers to report these units by the same unit type used to calculate the AMP and to use these units to calculate the weighted-AMP-based FULs prices. 2016-09-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 9440 139712 0

Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534 No Health Health Care Services
Yes No Printable Only Instruction CMS-367_Instructions_to_Labelers 2013.docx CMS-367a, -367b, -367c, and -367d Medicaid Drug Program Monthly and Quarterly Drug Reporting Format Yes Yes Printable Only Form 367 for omb 2013.pdf Yes No Printable Only Other CMS-367 disclosure statement.doc
Private Sector 9440 139712 0

2013-09-20-04:00

0938-0579 201104-0938-005 0938
             
        "Business Proposal Forms For Quality Improvement Organizations (QIOs)"
             
          
        
The submission of proposal information by current Quality Improvement Organizations and other bidders on the appropriate forms will satisfy CMS' need for meaningful, consistent, and verifiable data, which aids Federal procurement awards. 2014-07-31-04:00 Active William Parham 4107864669 No No No 21 1785 0

Business Proposal Forms For Quality Improvement Organizations (QIOs) No Health Health Care Services
Yes Yes Fillable Fileable Instruction CMS-718-721.Travel Form Instructions.doc CMS 718-721 CMS 718-721.J-8a 9th SOW CKD Spreadsheet Yes Yes Fillable Fileable Form CMS-718-721.J-8a 9th SOW CKD Spreadsheet.xlsx CMS 718-721 CMS 718-721.J-8a 9th SOW Disparities Spreadsheet Yes Yes Fillable Fileable Form CMS-718-721.J-8a 9th SOW Disparities Spreadsheet.xlsx CMS-718-721 CMS-718-721.J-8a 9th SOW Patient Pathways Spreadsheet Yes Yes Fillable Fileable Form CMS-718-721.J-8a 9th SOW Patient Pathways Spreadsheet.xlsx No No Fillable Fileable Instruction CMS-718-721.P9SOW - Instructions - ONC 0938-0579.doc CMS-718-721 CMS-718-721.Travel Detail Chart Yes Yes Fillable Fileable Form CMS-718-721.Travel Detail Chart.xls CMS-718-721 CMS-718-721.BP9SOW - Forms - OCN-0938-0579 Yes Yes Fillable Fileable Form CMS-718-721.BP9SOW - Forms - OCN-0938-0579.xlsx
Private Sector 21 1785 0

2011-07-24-04:00

0938-0581 201012-0938-013 0938
             
        "Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001"
             
          
        
Clincal Laboratory Certification - The application must be completed by entities performing laboratory's testing specimens for diagnostic or treatment purposes. This information is vital to the certification process. 2014-03-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 31520 23640 0

Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116) No Health Health Care Services
CMS-116 Clinical Laboratory Improvement Amendments (CLIA) Application For Certification Yes No Fillable Printable Form and instruction CMS-116.pdf
Private Sector 31520 23640 0

2011-03-25-04:00

0938-0582 201110-0938-010 0938
             
        "State Drug Rebate (Medicaid) (CMS-368 and R-144)"
             
          
        
Section 1927 of the Social Security Act requires each State Medicaid agency to report quarterly prescription drug utilization information to drug manufacturers and to CMS via form CMS-R-144. As part of this information, the State Medicaid agencies are required to report the total Medicaid rebate amount they claim they are owed by each drug manufacturer for each covered prescription drug product each quarter. In accordance with new reporting requirements established by the Patient Protection and Affordable Care Act, form CMS-R-144 is being revised to include a new column that will enable States to distinguish between fee-for-service and managed care utilization. 2014-11-30-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 224 12101 0

State Drug Rebate (Medicaid) No Health Health Care Services
CMS-368 State Agency Contact Form Yes Yes Fillable Fileable Form CMS Form 368.doc CMS-R-144 Medicaid Drug Rebate Invoice Yes Yes Fillable Fileable Form CMS R-144_2011.pdf Yes No Printable Only Instruction Invoice Instructions_Final_2011.doc Yes No Printable Only Instruction ACA Record Layout_Final_2011.docx Yes No Printable Only Instruction ACA Data Definitions_Final_2011.docx
State, Local, and Tribal Governments 224 12101 0

2011-11-23-05:00

0938-0599 201103-0938-007 0938
             
        "CLIA Budget Workload Reports and Supporting Regulations Contained in 42 CFR 493.1-.2001 (CMS-102, CMS-105)"
             
          
        
Information collected is used by CMS to determine the amount of Federal Reimbursement for compliance surveys. Use of the information includes program evaluation, audit, budget formulation and budget approval. 2014-05-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 50 4500 0

CLIA Budget Workload Reports and Supporting Regulations Contained in 42 CFR 493.1-.2001 (CMS-102, CMS-105) No Health Health Care Services
CMS-105 Planned Workload Report Yes Yes Fillable Printable Form and instruction 10511.pdf CMS-102 CLIA Budget/Expenditure Report Yes Yes Fillable Printable Form and instruction CMS-102 form.pdf
State, Local, and Tribal Governments 50 4500 0

2011-05-06-04:00

0938-0600 201302-0938-009 0938
             
        "Medicare Credit Balance Reporting Requirements and Supporting Regulations in 42 CFR 405.371, 405.378, and 413.20"
             
          
        
The collection of credit balance information is needed to ensure that millions of dollars in improper program payments are collected. Approximately 52,380 health care providers will be required to submit a quarterly credit balance report that identifies the amount of improper payments they received that are due to Medicare. The contractors will monitor the reports to ensure these funds are collected. 2016-06-30-04:00 Active William Parham 4107864669 No No No 183352 550056 0

Medicare Credit Balance Reporting Requirements and Supporting Regulations in 42 CFR 405.371, 405.378, and 413.20 No Health Health Care Services
CMS-838 Medicare Credit Balance Report Yes Yes Fillable Fileable Form and instruction CMS-838 Instrument2008revision.doc
Private Sector 183352 550056 0

2013-06-10-04:00

0938-0610 201312-0938-008 0938
             
        "Advanced Directives (Medicare and Medicard) - BDP-718"
             
          
        
Certain Medicare and Medicaid organizations are responsible for collecting and documenting in a prominent place in medical records whether an individual has executed an advanced directive. This document indicates the individual's preference if he/she is incapacitated. 2017-02-28-05:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 55044127 2836441 0

CMS-R-10 Form 83 - Part II (Annual Update) No Health Health Care Services Private Sector 39575 59363 0

CMS-R-10 Form 83 - Part II (Developing Advanced Directive) No Health Health Care Services Private Sector 2276 2276 0

CMS-R-10 Form 83 - Part II (Documenting Advanced Directive) No Health Health Care Services Private Sector 55000000 2770250 0

CMS-R-10 Form 83 - Part II (Policies and Procedures) No Health Health Care Services Private Sector 2276 4552 0

2014-02-06-05:00

0938-0612 201012-0938-016 0938
             
        "Information Collection Requirements (ICR) Contained in the Clinical Laboratory Improvement Amendments (CLIA) Regulations 42 CFR 493.1-.2001 (CMS-R-26)"
             
          
        
The ICRs referenced in 42 CFR part 493 outline the requirements necessary to determine an entities compliance with CLIA. CLIA requires laboratories that perform testing on human beings to meet performance requirements (quality standards) in order to be certified by HHS. HHS conducts inspections to determine a laboratory's compliance with the CLIA requirements. CLIA implements the certificate, laboratory standards, and inspection requirements. 2014-02-28-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 756240 11363280 0

Information Collection Requirements (ICR) Contained in the Clinical Laboratory Improvement Amendments (CLIA) Regulations 42 CFR Part 493.1-.2001 (CMS-R-26) No Health Health Care Services Federal Government 15125 226875 0

CLIA and ICRs contained in 42 CFR 493.1-.2001 (CMS-R-26) No Health Health Care Services Private Sector 695742 10454585 0

CLIA and ICRs contained in 493.1-.2001 No Health Health Care Services State, Local, and Tribal Governments 45373 681820 0

2011-02-11-05:00

0938-0618 201104-0938-007 0938
             
        "Limitations on Provider Related Donations and Health Care Related Taxes, etc. (CMS-R-148)"
             
          
        
This information collection is necessary to ensure compliance with Sections 1903 and 1923 of the Social Security Act for the purpose of preventing payment of FFP on amounts prohibited by statute. 2014-08-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 40 3200 0

Limitations on Provider Related Donations and Health Care Related Taxes, etc. No Health Health Care Services State, Local, and Tribal Governments 40 3200 0

2011-08-10-04:00

0938-0626 201305-0938-012 0938
             
        "Electronic Funds Transfer Authorization Agreement"
             
          
        
The primary function of the Electronic Funds Transfer Authorization Agreement (CMS 588) is to gather information from a provider/supplier to establish an electronic payment process. The legal authority to collect this information is found in Section 1815(a) of the Social Security Act. This section provides authority for the Secretary of Health and Human Services to pay providers/suppliers of Medicare services. Under 31 U.S.C. 3332(f)(1), all Federal payments, including Medicare payments to providers and suppliers, shall be made by electronic funds transfer. 31 U.S.C. 7701 (c) requires that any person or entity doing business with the Federal Government must provide their Tax Identification Number (TIN). Goal of the Provider/Supplier Enrollment Application Revisions The goal of evaluating and revising the CMS 588 agreement is to renew the data collection. Due to previous revisions (2006 and 2009), this form is user friendly and concise. Only two minor revisions for systems requirements will be made at this time, specifically adding a street address line for the location of the financial institution and adding an additional National Provider Identification (NPI) number collection field for those providers/suppliers who have more than one NPI. 2016-09-30-04:00 Active William Parham 4107864669 No No No 94000 23500 0

Electronic Funds Transfer Authorization Agreement No Health Health Care Services
CMS-588 EFT_Authorization_Agreement Yes No Fillable Fileable Form and instruction CMS-588_EFT_Authorization_Agreement.pdf
Private Sector 94000 23500 0

2013-09-26-04:00

0938-0653 201204-0938-006 0938
             
        "Post Cinical Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 493.1771, 483.1773, and 493.1777 (CMS-668B)"
             
          
        
To provide an opportunity and a mechanism for CLIA laboratories surveyed by CMS or CMS' agent to express their satisfaction and concerns about the CLIA survey process. 2015-08-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 10244 2561 0

Private Sector - Post Cinical Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 493.1771, 483.1773, and 493.1777 No Health Health Care Services
CMS-668B Post Clinical Laboratory Survey Questionnaire Yes No Fillable Fileable Form and instruction CMS668B.pdf
Private Sector 9556 2389 0

Federal Government - Post Cinical Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 493.1771, 483.1773, and 493.1777 No Health Health Care Services
CMS-668B Post Clinical Laboratory Survey Questionnaire Yes No Fillable Fileable Form and instruction CMS668B.pdf
Federal Government 43 11 0

State, Local, or Tribal Governments - Post Cinical Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 493.1771, 483.1773, and 493.1777 No Health Health Care Services
CMS-668B Post Clinical Laboratory Survey Questionnaire Yes No Fillable Fileable Form and instruction CMS668B.pdf
State, Local, and Tribal Governments 645 161 0

2012-08-08-04:00

0938-0657 201304-0938-008 0938
             
        "End-Stage Renal Disease (ESRD) Network Semi-Annual Cost Report Forms and Supporting Regulations in 42 CFR 405.2110 and 42 CFR 405.2112"
             
          
        
Submission of semi-annual cost reports allow CMS to review, compare, and project ESRD network costs. The reports are used as an early warning system to determine whether the networks are in danger of exceeding the total cost of the contract. Additionally, CMS can analyze line item costs to identify any significant aberations. 2016-06-30-04:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 36 108 0

End-Stage Renal Disease (ESRD) Network Semi-Annual Cost Report Forms and Supporting Regulations in 42 CFR 405.2110 and 42 CFR 405.2112 No Health Health Care Services
Yes Yes Fillable Fileable Instruction CMS-685 FINAL_Updated_J_6_A_Instructionsdjr012513.docx.docx CMS-685 Network Semi Annual Reprot Yes Yes Fillable Fileable Form Network Semi Annual Report xlsx.xlsx
Private Sector 36 108 0

2013-06-10-04:00

0938-0659 201102-0938-003 0938
             
        "Medicaid Drug Utilization Review (DUR) Annual Report (CMS-R-153 and CMS-R-153a, b, and c)"
             
          
        
Section 4401 of the Omnibus Budget Reconciliation Act of 1990 and section 1927(d) of the Social Security Act requires States to provide for a Medicaid Drug Utilization Review (DUR) program for covered outpatient drugs. The DUR program is required to assure that prescriptions are appropriate, medically necessary and are not likely to result in adverse medical results. Each State DUR program must consist of prospective drug use review, retrospective drug use review, data assessment of drug use against predetermined standards, and ongoing educational outreach activities. In addition, States are required to submit an annual DUR program report that includes a description of the nature and scope of State DUR activities as outlined in the statute and regulations. 2014-03-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 816 20298 0

Medicaid Drug Ulilization Review (DUR) Annual Report (CMS-R-153, CMS-R-153a, CMS-R-153b, and CMS-R-153c)(42 CFR 456.712) No Health Health Care Services
CMS-R-153, CMS-R-153a, CMS-R-153b, and CMS-R-153c Medicaid Drug Utilization Review Annual Report Yes Yes Fillable Printable Form and instruction 07-28-10 MEDICAID DRUG UTILIZATION REVIEW FINAL (2).pdf
State, Local, and Tribal Governments 204 1530 0

Claims Data and Other Record Reports Preparation (42 CFR 456.709) No Health Health Care Services State, Local, and Tribal Governments 204 408 0

Interventions (42 CFR 456.711) No Health Health Care Services State, Local, and Tribal Governments 204 12240 0

Review of Claims Data and Other Record Reports (42 CFR 456.711) No Health Health Care Services State, Local, and Tribal Governments 204 6120 0

2011-03-21-04:00

0938-0667 201305-0938-017 0938
             
        "Examination and Treatment for Emergency Medical Conditions and Women in Labor (EMTALA), 42 CFR 482.12, 488.18, 489.20, and 489.24"
             
          
        
This collection contains the requirements for hospitals in effort to prevent them from inappropriately transferring individuals with emergency medical conditions, as mandated by Congress. CMS uses this information to help assure compliance with this mandate. This information is not contained elsewhere in regulations. 2016-07-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 6149 1 0

Examination and Treatment for Emergency Medical Conditions and Women in Labor (EMTALA), 42 CFR 482.12, 488.18, 489.20, and 489.24, & HCFA-1005-IFC, PPS for Hospital Outpatient Services,... No Health Health Care Services Private Sector 6149 1 0

2013-07-26-04:00

0938-0676 201107-0938-007 0938
             
        "Reconciliation of State Invoice and Prior Quarter Adjustment Statement (CMS-304/304a)"
             
          
        
Section 1927 of the Social Security Act requires drug manufacturers to enter into and have in effect a rebate agreement with CMS in order for States to receive funding for drugs dispensed to Medicaid recipients. Drug manufacturers must explain to States any rebate payment adjustments for the current quarter, and any prior quarters. The information is used to reconcile drug rebate payments made by manufacturers with the State invoices of rebates due. 2014-10-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 4044 183120 0

Reconciliation of State Invoice and Prior Quarter Adjustment Statement (CMS-304) No Health Health Care Services
Yes No Printable Only Other Appendix C for CMS-304 & 304a_2011.doc Yes No Fillable Printable Other Appendix A for CMS-304_Final_ 2011.doc Yes No Printable Only Instruction Instructions for CMS-304 ROSI_Final_2011.doc CMS-304 Reconciliation of State Invoice (ROSI) Yes Yes Fillable Printable Form ROSI Form wiith Disclosure Statement_2011.pdf
Private Sector 1664 116480 0

Reconciliation of State Invoice and Prior Quarter Adjustment Statement (CMS-304A) No Health Health Care Services
Yes No Printable Only Instruction Instructions for CMS-304a PQAS_Final_2011.doc Yes No Printable Only Other Appendix A for CMS-304a_Final_ 2011.doc Yes No Printable Only Other Appendix C for CMS-304 & 304a_2011.doc CMS-304a Prior Quarter Adjustment Statement (PQAS) Yes Yes Fillable Fileable Form PQAS Form with Disclosure Statement_2011.pdf
Private Sector 2380 66640 0

2011-10-23-04:00

0938-0679 201303-0938-018 0938
             
        "Durable Medical Equipment Medicare Administrative Contractors (MAC) Regional Carrier, Certificate of Medical Necessity and Supporting Documentation"
             
          
        
This information is needed to correctly process claims and ensure that claims are properly paid. These forms contain medical information necessary to make an appropriate claim determination. Suppliers and physicians will complete these forms and as needed supply additional routine supporting documentation to process claims. 2016-06-30-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 462000 92400 0

Durable Medical Equipment Medicare Administrative Contractors (MAC) Regional Carrier, Certificate of Medical Necessity and Supporting Documentation No Health Health Care Services
CMS-849 CMS-849 -- SEAT LIFT MECHANISMS Yes No Fillable Fileable Form and instruction CMS849.pdf CMS-10126 CMS-10126 -- ENTERAL AND PARENTERAL NUTRITION Yes No Fillable Fileable Form and instruction CMS10126.pdf CMS-848 CMS-848 -- TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS) Yes No Fillable Fileable Form and instruction CMS848.pdf CMS-846 CMS-846 -- PNEUMATIC COMPRESSION DEVICES Yes No Fillable Fileable Form and instruction CMS846.pdf CMS-847 CMS-847 -- OSTEOGENESIS STIMULATORS Yes No Fillable Fileable Form and instruction CMS847.pdf CMS-10125 CMS-10125 -- EXTERNAL INFUSION PUMPS Yes No Fillable Fileable Form and instruction CMS10125.pdf CMS-854 CMS-854 -- CONTINUATION FORM Yes No Fillable Fileable Form and instruction CMS854.pdf
Private Sector 462000 92400 0

2013-06-10-04:00

0938-0685 201210-0938-009 0938
             
        "Medicare Enrollment Application"
             
          
        
The primary function of the CMS-855 Medicare enrollment application is to gather information from a provider or supplier that tells us who it is, whether it meets certain qualifications to be a health care provider or supplier, where it practices or renders services, the identity of the owners of the enrolling entity, and other information necessary to establish correct claims payments. For reasons discussed below, CMS is revising the CMS-855 Medicare Enrollment Applications Package (OMB No. 0938-0685). 2016-05-31-04:00 Active William Parham 4107864669 No No No 1740800 290609 0

Medicare Enrollment Applications No Health Health Care Services
855B Medicare Enrollment Application - Clinics/group Practices and Certain Other Suppliers Yes No Fillable Fileable Form and instruction CMS-855B.pdf 855A Medicare Enrollment Application - Institutional Providers No No Fillable Fileable Form and instruction CMS-855A.pdf 855R Reassignment of Medicare Benefits Yes No Fillable Fileable Form and instruction CMS-855R.pdf 855I Medicare Enrollment Application -Physicians and Non-Physician Practitioners Yes No Fillable Fileable Form and instruction CMS-855I.pdf
Private Sector 1740800 290609 0

2013-05-22-04:00

0938-0686 201105-0938-015 0938
             
        "Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and of State Exemption Under State Laboratory Programs and Supporting Regs (CMS-R-185)"
             
          
        
The information required is necessary to determine whether a private accreditation organization's or State licensure program's standards and accreditation/licensure process is equal to or more stringent than those of CLIA. 2014-07-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 96 384 0

Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and of State Exemption Under State Laboratory Programs and Supporting Regs (CMS-R-185) No Health Health Care Services Private Sector 96 384 0

2011-07-24-04:00

0938-0691 201401-0938-009 0938
             
        "Medicare Disproportionate Share Adjustment Procedures and Criteria and Supporting Regulations in 42 CFR 412.106"
             
          
        
A hospital's disproportionate share adjustment is determined by its fiscal intermediary (FI) using a combination of Medicare Part A and SSI data provided by CMS, and Medicare date calculated from the hospital's cost report. The data provided through these calculations are then compared to the qualifying criteria located in 42 CFR 412.106 to determine the final adjustment. If these calculations, based on the Federal fiscal year, do not allow the hospital to qualify for a disproportionate share adjustment, the hospital may request that they be performed using its cost reporting period. 2017-02-28-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 800 400 0

Medicare Disproportionate Share Adjustment Procedures and Criteria and Supporting Regulations in 42 CFR 412.106 No Health Health Care Services Private Sector 800 400 0

2014-02-12-05:00

0938-0692 201305-0938-016 0938
             
        "Medicare and Medicare Advantage Programs; Notification Procedures for Hospital Discharges : Important Message From Medicare"
             
          
        
As a result of the Weichardt v. Leavitt class action lawsuit and in response to public comments, CMS set forth a final rule in November 2006, CMS-4105-F, for how hospitals must notify Medicare beneficiaries who are hospital inpatients about their hospital discharge rights. Notice is required both for original Medicare beneficiaries and for beneficiaries enrolled in Medicare Advantage plans and other Medicare health plans subject to the MA regulations. Under the final rule, hospitals use a revised version of the Important Message from Medicare (IM), Form CMS-R-193 to explain discharge rights. Hospitals must issue the IM within two days of admission, and must obtain the signature of the beneficiary or his or her representative. Hospitals must also deliver a copy of the signed notice to each beneficiary not more than two days before the day of discharge. This notice was approved in 2007 to fulfill the regulatory requirement 2016-07-31-04:00 Active William Parham 4107864669 No No No 19840000 2976000 0

Medicare and Medicare Advantage Programs; Notification Procedures for Hospital Discharges : Important Message From Medicare (CMS-R-193) No Health Health Care Services
CMS-R-193 Mensaje Importante De Medicare Sobre Sus Derechos No No Paper Only Form and instruction 508_SpanishIM2013CMSR193v508.pdf CMS-R-193 Important Message from Medicare No No Paper Only Form and instruction 508_IM2013CMSR193v508.pdf
Private Sector 19840000 2976000 0

2013-07-26-04:00

0938-0697 201305-0938-003 0938
             
        "Medicaid Report on Payables and Receivables"
             
          
        
The Chief Financial Officers Act of 1990, as amended by the Government Management and Reform Act of 1994, requires government agencies to produce auditable financial statements. Form CMS-R-199 will collect accounting data from the States on payables and receivables. 2016-06-30-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 56 392 0

Medicaid Report on Payables and Receivables No Health Health Care Services
Yes Yes Fillable Fileable Instruction CMS-R-199.MedicaidInstructions508.pdf CMS-R-199 CMS-R-199 Yes No Fillable Printable Form CMS-R-199 Revised Form(2011).doc
State, Local, and Tribal Governments 56 392 0

2013-06-04-04:00

0938-0701 201208-0938-008 0938
             
        "Medicare Health Outcomes Survey (HOS) and Supporting Regulations at 42 CFR 422.152 "
             
          
        
The Centers for Medicare & Medicaid Services collects quality performance measures in order to hold the Medicare managed care industry accountable for the care being delivered, to enable quality improvement, and to provide quality information to Medicare beneficiaries in order to promote an informed choice. It is critical to CMS's mission that we collect and disseminate information that can be used to help beneficiaries choose among health plans, contribute to improved quality of care through identification of improvement opportunities, and assist CMS in carrying out its oversight and purchasing responsibilities. 2015-11-30-05:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 666120 219820 0

Medicare Health Outcomes Survey (HOS) and Supporting Regulations at 42 CFR 422.152 (CMS-10203) No Health Health Care Services Individuals or Households 0 0 0

Medicare Health Outcomes Survey (HOS) and Supporting Regulations 42 CFR 422.152 No Health Health Care Services
CMS-10203 Medicare HOS-Modified 2013 Questionnaire (English) Yes Yes Fillable Fileable Form and instruction Attachment_6_HOS_M_Questionnaire_English.pdf CMS-10203 Medicare HOS 2013 Questionnaire (English) Yes Yes Fillable Fileable Form and instruction Attachment_4_HOS_2_5_Questionnaire_English_REVISED.pdf
Individuals or Households 666120 219820 0

2012-11-07-05:00

0938-0702 201303-0938-008 0938
             
        "Information Collection Requirements Referenced in HIPAA for the Group Market, Supporting Regulations 45 CFR 146, and forms/instructions"
             
          
        
The provisions of title XXVII of the Public Health Service Act (PHS Act) are designed to make it easier for people to get access to health care coverage and to reduce the limitations that can be put on the coverage. Sections 2723 and 2761 of the PHS Act direct CMS to enforce a provision (or provisions) of title XXVII of the PHS Act with respect to health insurance issuers when a state has notified CMS that it has not enacted legislation to enforce or that it is not otherwise enforcing a provision (or provisions) of the individual and group market reforms with respect to health insurance issuers, or when CMS has determined that a state is not substantially enforcing one or more of those provisions. This collection also pertains to notices issued by individual and group health insurance issuers and self-funded non-Federal governmental plans. This collection includes the issuance of certificates of creditable coverage; notification of preexisting condition exclusions; notification of special enrollment rights; and review of issuers' filings of individual and group market products or similar Federal review in cases in which a state is not enforcing a title XXVII individual or group market provision. 2016-04-30-04:00 Active Jamaa Hill 301 492-4190 No Yes No 39831442 3760421 0

Information Collection Requirements for Compliance with Individual and Group Market Reforms under Title XXVII of the Public Health Service Act No Health Health Care Services
CMS-10430 Model_Election_Exemption Yes No Fillable Fileable Form and instruction CMS-10430_Model_Election_Exemption.pdf CMS-10430 Model_Notice_to_Enrollees Yes No Fillable Fileable Form and instruction CMS-10430_Model_Notice_to_Enrollees.pdf
Private Sector 39831442 3760421 0

Information Collection Requirements Referenced in HIPAA for the Group Market, Supporting Regulations 45 CFR 146, and forms/instructions (CMS-R-206) No Health Health Care Services State, Local, and Tribal Governments 0 0 0

2013-04-01-04:00

0938-0707 201209-0938-006 0938
             
        "Model Application Template for State Child Health Plan Under Title XXI of the Social Security Act, State Children's Health Insurance Program, & Model Application Template & Instructions (CMS-R-211)"
             
          
        
States are required to submit Title XXI plans and amendments for approval by the Secretary pursuant to section 2102 of the Social Security Act in order to receive funds for initiating and expanding health insurance coverage for uninsured children. The model application Template is used to assist States in submitting a State Child Health Plan and amendments to that plan. 2014-08-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 40 3200 0

Model Application Template for State Child Health Plan Under Title XXI of the Social Security Act, State Children's Health Insurance Program, & Model Application Template & Instructions No Health Health Care Services
CMS-R-211 Template for Child Health Plan Under Title XXI of the Social Security Act Children's Health Insurance Program Yes Yes Fillable Printable Form and instruction Title XXI State Plan revised PRA 9-19-12.docx
State, Local, and Tribal Governments 40 3200 0

2012-10-09-04:00

0938-0714 201101-0938-008 0938
             
        "Issuance of Advisory Opinions Concerning Physicians' Referrals (CMS-R-216)"
             
          
        
Section 1877(g)(6) of the Social Security Act requires that the Department of Health and Human Services issue advisory opinions concerning whether the referral of a Medicare patient by a physician for designated health services" (other than clinical laboratory services) is prohibited under the physician referral provisions of the Social Security Act. The Centers for Medicare & Medicaid Services promulgated 42 CFR 411.370 through 411.389 to comply with this statutory mandate. The collection of information contained in 42 CFR 411.372 and 411.373 is necessary to allow CMS to consider requests for advisory opinions and provide accurate and useful opinions. 2014-03-31-04:00 Active Bonnie Harkless 4107865666 No No No 25 500 0

Procedures for advisory opinions concerning physician referrals (CMS-R-216) No Health Health Care Services Private Sector 25 500 0

2011-03-21-04:00

0938-0730 201306-0938-007 0938
             
        "Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.410, 405.430, 405.435, 405.440, 405.445, 405.455, 410.61, 415.110, and 424.24"
             
          
        
Section 4507 of BBA 1997 amended section 1802 of the Social Security Act to permit certain physicians and practitioners to opt-out of Medicare and to provide through private contracts services that would otherwise be covered by Medicare. Under such contracts the mandatory claims submission and limiting charge rules of section 1848(g) of the Act would not apply. Subpart D and the Supporting Regulations contained in 42 CFR 405.410, 405.430, 405.435, 405.440, 405.445, and 405.455, counters the effect of certain provisions of Medicare law that, absent section 4507 of BBA 1997, preclude physicians and practitioners from contracting privately with Medicare beneficiaries to pay without regard to Medicare limits. 2016-07-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 26820 7197 0

Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.410 (a) No Health Health Care Services Private Sector 600 1200 0

Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.410(a) No Health Health Care Services Private Sector 25000 4167 0

Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.410 (b) No Health Health Care Services Private Sector 600 1200 0

Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.445(b)(2) No Health Health Care Services Private Sector 60 10 0

Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.455(b)(4) No Health Health Care Services Private Sector 60 120 0

Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.455(a) No Health Health Care Services Private Sector 500 500 0

2013-07-26-04:00

0938-0731 201103-0938-012 0938
             
        "Quarterly Children's Health Insurance Program Statement of Expenditures for Title XXI (CMS-21 and 21B)"
             
          
        
States use the Form 21 to report budget, expenditure, and related statistical information required for implementation of the Children's Health Insurance Program. 2014-04-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 448 7840 0

Quarterly Children's Health Insurance Program Statement of Expenditures for Title XXI No Health Health Care Services
CMS-21B State CHIP Budget Report for the Title XXI Program Yes Yes Fillable Fileable Form and instruction CMS21B.pdf CMS-21 Quarterly CHIP Statement of Expenditures for the Title XXI Program Yes Yes Fillable Fileable Form and instruction CMS21Forms.pdf
State, Local, and Tribal Governments 448 7840 0

2011-04-22-04:00

0938-0732 201110-0938-001 0938
             
        "Medicare Advantage and Medicare Fee-For-Service Consumer Assessment of Healthcare Providers and Systems (CAHPS) Survey "
             
          
        
CMS has fielded the MA (Consumer Assessment of Health Care Providers and Systems) CAHPS Survey annually since 1998, the Medicare FFS CAHPS Survey annually since 2000, and the MA DP and Stand Alone PDP CAHPS survey annually since 2006. The Medicare CAHPS is a national survey of health and prescription drug plans conducted at the contract level for MA, MA PD and Stand Alone PDP plans and at the state level for Medicare fee-for-service. Medicare CAHPS provides data to permit preparation of plan performance measures to assist Medicare beneficiaries in their selection of a health and/or prescription drug plan and help policymakers and others assist the Medicare program and Medicare plans design and monitor patient-centered quality improvement initiatives. The 2009 Call letter for MA and MA PD plans requires these plans to contract with private vendors from a list selected by CMS to conduct the 2011 Medicare CAHPS survey for their plan at the contract level and provide the collected data to CMS for analyses and preparation of CAHPS measures for use in consumer and plan reports and for quality improvement purposes for MA, MA PD, and Stand Alone PDP plans. CMS will continue to collect the Medicare FFS CAHPS data from surveys at the state and some sub-state levels. This revision to a currently approved collection is to add questions focusing on care coordination. The Medicare CAHPS survey has taken the OMB No. 0935-0732. 2015-06-30-04:00 Active William Parham 4107864669 No No No 598809 249441 3045000

Medicare Advantage and Medicare Fee-For-Service CAHPS Survey: MA Survey (CMS-R-246) No Health Health Care Services
CMS-R-246 Medicare Advantage Only - Survey No No Paper Only Form and instruction Medicare Advantage Only - Survey.pdf
Individuals or Households 427200 170880 0

Medicare Advantage and Medicare Fee-For-Service CAHPS Survey: MA & PDP Plan Burden No Health Health Care Services
CMS-R-246 MA-PDP Survey No No Paper Only Form and instruction MA-PDP Survey.pdf
Private Sector 609 32886 3045000

Medicare Advantage and Medicare Fee-For-Service CAHPS Survey: Medicare FFS Survey (CMS-R-246) No Health Health Care Services
CMS-R-246 Medicare FFS Survey No No Paper Only Form and instruction Medicare FFS Survey.pdf
Individuals or Households 58500 17550 0

Medicare Advantage and Medicare Fee-For-Service CAHPS Survey: Stand Alone PDP Survey (CMS-R-246) No Health Health Care Services
CMS-R-246 Stand Alone PDP Survey No No Fillable Fileable Form and instruction Stand Alone PDP Survey.pdf
Individuals or Households 112500 28125 0

2012-06-01-04:00

0938-0734 201107-0938-005 0938
             
        "Data Use Agreement Information Collection Requirements, Model Language, and Supporting Regulations in 45 CFR Section 5b"
             
          
        
he Privacy Act of 1976, ?552a requires the Centers for Medicare & Medicaid Services (CMS) to track all disclosures of the agency's Personally Identifiable Information (PII) and the exceptions for these data releases. CMS is also required by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the Federal Information Security Management Act (FISMA) of 2002 to properly protect all PII data maintained by the agency. When entities request CMS PII data, they enter into a Data Use Agreement (DUA) with CMS. The DUA stipulates that the recipient of CMS PII data must properly protect the data according to FISMA and also provide for its appropriate destruction at the completion of the project/study or the expiration date of the DUA. The DUA form enables the data recipient and CMS to document the request and approval for release of CMS PII data. The form requires the submitter to provide the Requestor's organization; project/study name; CMS contract number (if applicable); data descriptions and the years of the data; retention date; attachments to the agreement; name, title, contact information to include address, city, state, zip code, phone, e-mail, signature and date signed by the requester and custodian; disclosure provision; name of Federal Agency sponsor; Federal Representative name, title, contact information, signature, date; CMS representative name, title, contact information, signature and date; and concurrence/non-concurrence signatures and dates from 3 CMS System Manager or Business Owners. While the data elements collected are not subject to change, the individualized clauses that are incorporated into any specific DUA are subject to change based on a specific case or situation such as disclosures to states, oversight agencies or DUAs for disproportionate share hospital (DSH) data requests as well as updates to DUAs with additional data descriptions, changes to the requestor or adding custodians to current DUAs. 2014-12-31-05:00 Active William Parham 4107864669 No No No 2200 1100 0

Data Use Agreement Information Collection Requirements, Model Language, and Supporting Regulations in 45 CFR Section 5b No Health Health Care Services
CMS-R-235 CMS-R-235.Tab_2i Yes No Fillable Fileable Form and instruction CMS-R-235.Tab_2i_Draft.pdf CMS-R-235 CMS-R-235.Tab_2j Yes No Fillable Fileable Form and instruction CMS-R-235.Tab_2j_Draft.pdf CMS-R-235 CMS-R-235.Tab_2b Yes No Fillable Fileable Form and instruction CMS-R-235.Tab_2b_Draft.pdf CMS-R-235 CMS-R-235.Tab_2a Yes No Fillable Fileable Form and instruction CMS-R-235.Tab_2a_Draft.pdf CMS-R-235 CMS-R-235.Tab_2e Yes No Fillable Fileable Form and instruction CMS-R-235.Tab_2e_Draft.pdf CMS-R-235 CMS-R-235.Tab_2f Yes No Fillable Fileable Form and instruction CMS-R-235.Tab_2f_Draft.pdf CMS-R-235 CMS-R-235.Tab_2d Yes No Fillable Fileable Form and instruction CMS-R-235.Tab_2d_Draft.pdf CMS-R-235 CMS-R-235.Tab_2c Yes No Fillable Fileable Form and instruction CMS-R-235.Tab_2c_Draft.pdf
Private Sector 2200 1100 0

2011-12-12-05:00

0938-0746 201104-0938-006 0938
             
        "Medicaid Disproportionate Share Hospital Annual Reporting (CMS-R-266)"
             
          
        
Section 1923(a)(2)(D) of the Act requires the States to submit an annual report that identifies each DHS payment under the State's Medicaid program in the preceding fiscal year and the amount of DSH payments paid to that hospital in the same year and such other information as the Secretary determines necessary to ensure the appropriateness of DHS payments. The information supplied will satisfy the requirements under section 1923(a)(2)(D) of the Act as well. 2014-05-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 52 1976 0

Medicaid Disproportionate Share Hospital Annual Reporting No Health Health Care Services State, Local, and Tribal Governments 52 1976 0

2011-05-10-04:00

0938-0749 201209-0938-002 0938
             
        "On-Site Inspection for Durable Medical Equipment (DME) Supplier Location and Supporting Regulations in 42 CFR, Section 424.57"
             
          
        
CMS is mandated to identify and implement measures to prevent fraud and abuse in the Medicare program. To meet this challenge, CMS has moved forward to improve the quality of the process for enrolling suppliers into the Medicare program by establishing a uniform application for enumerating suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). Implementation of enhanced procedures for verifying the enrollment information has also improved the enrollment process. As part of this process, verification of compliance with supplier standards is necessary. The site investigation form has been used in the past to aid the Medicare contractor (the National Supplier Clearinghouse and/or its subcontractors) in verifying compliance with the required supplier standards found in 42 CFR 424.57(c). The primary function of the site investigation form is to provide a standardized, uniform tool to gather information from a DMEPOS supplier that tells us whether it meets certain qualifications to be a DMEPOS supplier (as found in 42 CFR 424.57(c)) and where it practices or renders its services. 2015-09-30-04:00 Active William Parham 4107864669 No No No 30000 15000 0

On-Site Inspection for Durable Medical Equipment (DME) Supplier Location and Supporting Regulations in 42 CFR, Section 424.57 No Health Health Care Services
CMS-R-263 DMEPOS Site Visit Form No Paper Only Form and instruction PE-SACU Site Visit Inspection Form - final - 09202012.pdf
Private Sector 30000 15000 0

2012-09-25-04:00

0938-0756 201107-0938-016 0938
             
        "MSInteractive Survey Tool for www.medicare.gov"
             
          
        
The purpose of this submission is to continue to collect information from Internet users as they exit from the Websites Medicare.gov and CMS.gov. To ensure that we gather information about user reactions to the Websites, we have developed a survey tool that users can complete when they exit either site or by accessing a link on the bottom bar on the page. The responses on this survey tool will help CMS to make appropriate changes to the Websites in the future. The survey tool contains questions about the information that visitors are seeking from the sites, the degree to which either site was useful to them, the improvements that they would like to see in the sites, and their general comments. 2014-12-31-05:00 Active William Parham 4107864669 No No No 7000 1167 0

MSInteractive Survey Tool for www.medicare.gov No Health Health Care Services
CMS-R-268 MSIInteractive Survey tool for www.,edicare.gov Yes Yes Fillable Fileable Form and instruction CMS-R-268.REVISED- Collection_Instrument_12-03-10[1].pdf
Individuals or Households 4900 817 0

MSInteractive Survey Tool for www.medicare.gov No Health Health Care Services
CMS-R-268 MSIInteractive Survey tool for www.medicare.gov Yes Yes Fillable Fileable Form and instruction CMS-R-268.REVISED- Collection_Instrument_12-03-10[1].pdf
Private Sector 2100 350 0

2011-12-12-05:00

0938-0758 201312-0938-003 0938
             
        "Hospice Cost Report and Supporting Regulations in 42 CFR 413.20 and 413.24"
             
          
        
The Hospice Cost and Data Report provides for the collection of data from providers for rate evaluations for the Prospective Payment System (PPS). The data is used by CMS to update the PPS as mandated by Congress. 2017-02-28-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 2751 517188 0

Hospice Cost Report and Supporting Regulations in 42 CFR 413.20 and 413.24 No Health Health Care Services
Yes No Fillable Printable Instruction R1p243 [rev 11-22-2013].doc CMS-1984-14 Hospice Cost Report Yes Yes Fillable Printable Form R1p243f.pdf
Private Sector 2751 517188 0

2014-02-06-05:00

0938-0760 201312-0938-002 0938
             
        "OASIS Collection Requirements as Part of the CoPs for HHAs and Supporting Regulations"
             
          
        
We are seeking approval of revisions to a currently approved data collection instrument titled: Outcome and Assessment Information Set (OASIS-C). The revised/ upgraded version of the OASIS item set is titled OASIS -C1. OASIS is a core standard assessment data set that Home Health Agencies (HHAs) integrate into their own patient-specific, comprehensive assessment to identify each patient's need for home care that meets the patient's medical, nursing, rehabilitative, social, and discharge planning needs. The Medicare conditions of participation (CoPs) have mandated the use the OASIS data set by HHAs when evaluating adult, non-maternity patients receiving skilled services since 1999. OASIS data are used for both HHA quality measurement and payment adjustment. The current version of the OASIS data set (OASIS-C) includes items which must be updated to enable agencies to report patient diagnoses using the ICD-10 coding set. In addition, since the OASIS-C was implemented in January 2010, a number of changes to the format and/or wording of items and response options have been recommended. These revisions are designed to improve item clarity, address issues raised by stakeholders, and increase harmonization with data collection in other post-acute settings. . Also, in 2012, CMS and its contractors identified opportunities to eliminate collection of eight items at various collection time points, as well as make clarifications to item wording. A more detailed description of these changes and their impact on the total burden associated with the collection of the proposed OASIS-C1 data set is detailed in the Supporting Statement A. 2017-02-28-05:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 17280904 15320253 0

Medicare and Medicaid OASIS Collection Requirements (Data collection) No Health Health Care Services
CMS-R-245 OASIS-C1 Yes Yes Fillable Fileable Form and instruction Revised OASIS-C 1. 09.27.13. 508.pdf
Private Sector 17268890 15224141 0

Medicare and Medicaid Programs OASIS Collection Requirements (Training) No Health Health Care Services
CMS-R-245 OASIS-C1 Yes Yes Fillable Fileable Form and instruction Revised OASIS-C 1. 09.27.13. 508.pdf
Private Sector 12014 96112 0

2014-02-06-05:00

0938-0763 201301-0938-007 0938
             
        "The Plan Benefit Package (PBP) and Formulary Submission for Advantage (MA) Plans and Prescription Drug Plans (PDPs)"
             
          
        
CMS requires that MA and PDP organizations submit a completed formulary and PBP as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to CMS for review and approval. 2014-05-31-04:00 Active William Parham 4107864669 No No No 6070 56710 4366651

CY2013 Plan Benefit Package (PBP) Software and Formulary Submission - CMS-R-262 No Health Health Care Services Private Sector 6070 56710 4366651

2013-05-15-04:00

0938-0776 201306-0938-001 0938
             
        "Medicare Program:  Process for Making National Coverage Determinations"
             
          
        
These information collection requirements provide the process CMS uses to make a national coverage decision for a specific item or service under sections 1862 and 1871 of the Social Security Act. This streamlines our decision making process and increases the opportunities for public participation in making national coverage decisions. 2016-08-31-04:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 200 8000 0

Medicare Program: Process for Making National Coverage Determinations No Health Health Care Services
CMS-R-290 CMS-R-290 Collection Requirements No No Paper Only Form and instruction CMS-R-290.Instrument (Reporting Requirements).doc
Private Sector 200 8000 0

2013-08-12-04:00

0938-0778 201305-0938-014 0938
             
        "Medicare Health Plan Appeals and Grievance Data Collection and Reporting Requirements, Data Disclosure Requirements under section 422.111"
             
          
        
Medicare Advantage organizations (including MA plans and demonstrations) will collect information on appeals and grievance timeliness measures as well as dispositions. MA organizations will provide appeals and grievance information to individuals eligible to elect an MA organization, when requested, to help them make informed decisions about health plan performance. 2016-07-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 52260 5414 0

Collecting Appeals and Grievance Data No Health Health Care Services Private Sector 1340 1340 0

Reporting Appeals and Grievance Data No Health Health Care Services Private Sector 50920 4074 0

2013-07-26-04:00

0938-0786 201206-0938-003 0938
             
        "External Quality Review of Medicaid MCOs and Supporting Regulations in 42 CFR 438.360, 438.362, and 438.364 (CMS-R-305)"
             
          
        
The results of Medicare reviews, Medicare accreditation surveys, and Medicaid external quality reviews will be used by States in assessing the quality of care provided to Medicaid beneficiaries provided by managed care organizations and to provide information on the quality of the care provided to the general public upon request. 2015-09-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 70 415643 0

External Quality Review of Medicaid MCOs and Supporting Regulations in 42 CFR 438.360, 438.362, and 438.364 No Health Health Care Services State, Local, and Tribal Governments 70 415643 0

2012-09-07-04:00

0938-0787 201401-0938-002 0938
             
        "Request for Employment Information"
             
          
        
This information is needed to determine whether an individual is eligible to enroll in Medicare Part B or Premium Part A under the provisions of section 1837(i) of the Social Security Act (The Act) and/or qualify for a reduction in the premium amount under the provisions of section 1839(b) of the Act. 2016-09-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 15000 5000 0

Request for Employment Information No Community and Social Services Social Services
CMS-R-297 (CMS-L564) SP Solicitud De Informaciobre El Empleo Yes No Fillable Printable Form and instruction CMS-L564_SP_508_120413.pdf CMS-R-297 (CMS-L564) Request for Employment Information Yes No Fillable Printable Form and instruction CMS-L564_508_120413.pdf
Private Sector 15000 5000 0

2014-02-12-05:00

0938-0790 201011-0938-007 0938
             
        "Medicare and Medicaid; Programs For All-Inclusive Care For The Elderly (PACE) Contained in 42 CFR 460.12-460.210"
             
          
        
PACE organizations must demonstrate their ability to provide quality community-based care for the frail elderly who meet their State's nursing home eligibility standards using capitated payments from Medicare and the state. The model of care includes as core services the provision of adult day health care and multidisciplinary team case management, through which access to and allocation of all health services is controlled. Physician, therapeutic, ancillary, and social support services are provided in the participant's residence or on-site at the adult day health center. PACE programs must provide all Medicare and Medicaid covered services including hospital, nursing home, home health, and other specialized services. Financing of this model is accomplished through prospective capitation of both Medicare and Medicaid payments. 2014-03-31-04:00 Active Bonnie Harkless 4107865666 No No No 99 81911 0

Medicare and Medicaid; Programs For All-Inclusive Care For The Elderly (PACE) Contained in 42 CFR 460.12-460.210 No Health Health Care Services Private Sector 74 75358 0

Medicare and Medicaid; Programs For All-Inclusive Care For The Elderly (PACE) Contained in 42 CFR 460.12-460.210 No Health Health Care Services State, Local, and Tribal Governments 25 6553 0

2011-03-06-05:00

0938-0798 201009-0938-013 0938
             
        "(CMS-R-240) Prospective Payments for Hospital Outpatient Services and Supporting Regulations in 42 CFR  413.65"
             
          
        
Section 413.65(b)(3) states that a provider which is seeking a determination of provider-based status for a facility not located on the provider's campus must submit an attestation of compliance with applicable provider-based requirements and must supply documentation supporting its attestation at the time the attestation is made. Section 413.65(a)(1)(ii) establishes a listing of specific facilities for which determinations for provider-based status for payment purposes are not made. As CMS removed certain CAH-based facilities from this list, such facilities are allowed to apply for provider-based determination and are required to meet all provider-based requirements before billing for hospital or CAH based services. 2014-02-28-05:00 Active Bonnie Harkless 4107865666 No No No 500405 26563 0

(CMS-R-240) Prospective Payments for Hospital Outpatient Services and Supporting Regulations in 42 CFR 413.65 No Health Health Care Services Private Sector 500405 26563 0

(CMS-R-240) Prospective Payments for Hospital Outpatient Services and Supporting Regulations in 42 CFR 413.24, 413.65 No Health Health Care Services Private Sector 0 0 0

2010-10-29-04:00

0938-0802 201106-0938-006 0938
             
        "Eligibility of Drugs, Biologicals, and Radiopharmaceutical Agents for Transitional Pass-Through Status Under the Hospital Outpatient Prospective Payment System (OPPS) in 42 CFR 419.64"
             
          
        
Section 1833(t)(6) of the Social Security Act provides for temporary additional payments or "transitional pass-through payments" for certain drugs and biological agents. Interested parties such as hospitals, pharmaceutical companies, and physicians can apply for transitional pass-through payment for drugs and biologicals used with services covered under the OPPS. CMS uses this information to determine if the criteria for making a transitional pass-through payment are met and if an interim Healthcare Common Procedure Coding System (HCPCS) code for a new drug or biological is necessary. 2015-01-31-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 30 480 0

Eligibility of Drugs, Biologicals, and Radiopharmaceutical Agents for Transitional Pass-Through Status Under the Hospital Outpatient Prospective Payment System (OPPS) in 42 CFR 419.64 No Health Health Care Services Private Sector 30 480 0

2012-01-20-05:00

0938-0818 201308-0938-019 0938
             
        "Expanded Coverage for Diabetes Outpatient Self-Management Training Services and Supporting Regulations Contained in 42 CFR 410.141, 410.142, 410.143, 410.144, 410.145, 410.146...."
             
          
        
42 CFR 410.141-410.146 and 414.63 provide for uniform coverage of diabetes outpatient self-management training services. These services include educational and training services furnished to a beneficiary with diabetes by an entity approved to furnish the services. The physician or qualified nonphysician practitioner treating the beneficiary's diabetes certifies that these services are needed as part of a comprehensive plan of care. The The regulations set forth the quality standards that an entity is required to meet in order to participate in furnishing diabetes outpatient self-management training services. 2016-09-30-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 5327 197543 0

Expanded Coverage for Diabetes Outpatient Self-Management Training Services and Supporting Regulations Contained in 42 CFR 410.141, 410.142, 410.143, 410.144, 410.145, 410.146.... No Health Health Care Services Private Sector 5327 197543 0

2013-09-20-04:00

0938-0829 201308-0938-010 0938
             
        "Notice of Denial of Medical Coverage (or Payment) (NDMCP)"
             
          
        
Section 1852(g)(1)(B) of the Social Security Act (SSA) requires Medicare health plans to provide enrollees with a written notice in understandable language that explains the plan's reasons for denying a request for a service or payment for a service the enrollee has already received. The written notice must also include a description of the applicable appeals processes. Regulatory authority for this notice is set forth in Subpart M of Part 422 at 42 CFR 422.568, 422.572, 417.600(b), and 417.840. Section 1932 of the Social Security Act (SSA) sets forth requirements for Medicaid managed care plans, including beneficiary protections related to appealing a denial of coverage or payment. The Medicaid managed care appeals regulations are set forth in Subpart F of Part 438 of Title 42 of the CFR. Rules on the content of the written denial notice can be found at 42 CFR 438.404. This notice combines the existing Notice of Denial of Medicare Coverage with the Notice of Denial of Payment and includes optional language to be used in cases where a Medicare health plan enrollee also receives full Medicaid benefits that are being managed by the Medicare health plan. 2016-06-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 6960410 1159604 0

Notice of Denial of Medical Coverage (or Payment) No Health Health Care Services
CMS-10003 Notice of Denial of Medical Coverage (Spanish) Yes No Fillable Printable Form SPA_Integrated Denial Notice_clean_03 18 2013v508 - Spa.pdf Yes No Printable Only Instruction Instructions_Integrated Denial Notice_clean_03 26 2013v508.pdf CMS-10003 Notice of Denial of Medical Coverage Yes No Fillable Printable Form Integrated Denial Notice_clean_03 26 2013v508.pdf
Private Sector 6960410 1159604 0

2013-09-19-04:00

0938-0832 201011-0938-006 0938
             
        "Health Insurance Benefit Agreement and Supporting Regulations at 42 CFR Part 489 and 491 (CMS-1561)"
             
          
        
Applicants to the Medicare program are required to agree to provide services in accordance with Federal requirements. The CMS-1561 and 1561A are essential for CMS to ensure that applicants are in compliance with the requirements. Applicants are required to sign the completed form and provide operational information to CMS to assure that they continue to meet the requirements after approval. 2014-02-28-05:00 Active Melissa Musotto 4107866962 No No No 3000 500 0

Health Insurance Benefit Agreement and Supporting Regulations at 42 CFR Part 489 and 491 No Health Health Care Services
CMS-1561A Health Insurance Benefits Agreement for RHC No No Paper Only Form and instruction CMS-1561A Health Insurance Benefits Agreement.tif CMS-1561 Health Insurance Benefits Agreement No No Paper Only Form and instruction CMS-1561 form.tif
Private Sector 3000 500 0

2011-02-27-05:00

0938-0833 201207-0938-004 0938
             
        "Restraint and Seclusion Standards for Psychiatric Residential Treatment Facilities (CMS-R-306)"
             
          
        
Psychiatric residential treatment facilities are required to report deaths, serious injuries and attempted suicides to State Medicaid Agency and Protection and Advocacy Organization. Also required to provide residents restraint and seclusion policy in writing, and to document resident record of all activities involving use of restraint and seclusion. 2015-07-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 1414141 415668 0

Restraint and Seclusion Standards for Psychiatric Residential Treatment Facilities No Health Health Care Services Private Sector 1414141 415668 0

2012-07-26-04:00

0938-0841 201010-0938-006 0938
             
        "State Children's Health Insurance Program and Supporting Regulations in 42 CFR 431.636, 457.50, 457.60, 457.70, 457.340, 457.350, 457.431, 457.440, 457.525, 457.560,..."
             
          
        
States are required to submit title XXI plans and amendments for approval by the Secretary pursuant to section 2102 of the Social Security Act in order to receive funds for initiating and expanding health insurance coverage for uninsured children. States are also required to submit State expenditure and statistical reports, annual reports and State evaluations to the Secretary as outlined in the XXI of the Social Security Act. 2014-02-28-05:00 Active Melissa Musotto 4107866962 No No No 1114124 864973 0

State Children's Health Insurance Program and Supporting Regulations in 42 CFR 431.636, 457.50, 457.60, 457.70, 457.340, 457.350, 457.431, 457.440, 457.525, 457.560,... No Health Health Care Services State, Local, and Tribal Governments 1114124 864973 0

2011-01-10-05:00

0938-0842 201106-0938-001 0938
             
        "Inpatient Rehabilitation Assessment Instrument and Data Set for PPS for Inpatient Rehabilitation Facilities"
             
          
        
The Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) is an instrument for collecting standardized patient assessment data for 1) the objective assignment of Medicare beneficiaries to appropriate Case Mix Groups (CMGs); 2) the development of a system to monitor the effects of an inpatient rehabilitation facility prospective payment system on patient care and outcomes; 3) the determination of whether future adjustments to the CMGs are warranted; and 4) the development of an integrated system for post-acute care. The information provided on the IRF-PAI is used to establish reimbursement under the prospective payment system for inpatient rehabilitation facility services for the Medicare program. 2015-02-28-05:00 Active William Parham 4107864669 No Yes No 486550 413568 0

Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) data and Supporting Regulations in 42 CFR 412 Subpart P (CMS-10036) No Health Health Care Services
Yes No Fillable Fileable Instruction CMS-10036.IRF-PAI pressure ulcer instructions for PRA.docx CMS-10036 IRF PAI Instrument Yes Yes Fillable Fileable Form CMS-10036.Draft IRF-PAI Instrument.pdf
Private Sector 424020 360417 0

Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) data and Supporting Regulations in 42 CFR 412 Subpart P No Health Health Care Services
CMS-10036 IRF PAI Instrument Yes Yes Fillable Fileable Form CMS-10036.Draft IRF-PAI Instrument.pdf Yes No Fillable Fileable Instruction CMS-10036.IRF-PAI pressure ulcer instructions for PRA.docx
State, Local, and Tribal Governments 59200 50320 0

Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) data and Supporting Regulations in 42 CFR 412 Subpart P No Health Health Care Services
Yes No Fillable Fileable Instruction CMS-10036.IRF-PAI pressure ulcer instructions for PRA.docx CMS-10036 IRF PAI Instrument Yes No Fillable Fileable Form CMS-10036.Draft IRF-PAI Instrument.pdf
Federal Government 3330 2831 0

2012-02-28-05:00

0938-0850 201302-0938-008 0938
             
        "State Health Insurance Assistance Program (SHIP) Client Contact Form, Pubic and Media Activity Form, and Resource Report Form"
             
          
        
Grant funds are awarded by the Centers for Medicare & Medicaid Services (CMS) to states to provide information, counseling and assistance to beneficiaries relating to Medicare and Medicaid matters as well as Medicare supplement policies, managed care options including Medicare Advantage, long-term care insurance, and other health insurance benefit information. States may carry out the objective of the grants by providing one-on-one counseling, either face-to-face or over the telephone, by trained paid and volunteer staff, by distributing written informational materials, or by holding group educational seminars and presentations and outreach events. The current Client Contact Form, Public and Media Activity Report Form, and Resource Report Form have been used to collect data to evaluate program effectiveness and improvement, and these forms expire July 31, 2013. 2016-06-30-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 2346465 195642 0

Client Contact Form No Health Health Care Services
CMS-10028 CMS-10028.Client Contact Form Yes Yes Fillable Fileable Signable Form Client Contact Form Items Straight Text - For 508 Compliant Document - 09 Jan 2013.pdf
State, Local, and Tribal Governments 2269848 189154 0

Public and Media Activity Report Form (PAM) No Health Health Care Services
CMS-10028 Public and Media Activity Form (PAM) Yes Yes Fillable Fileable Form and instruction Public and Media Form Items Straight Text - For 508 Compliant Document - 09 Jan 2013.pdf
State, Local, and Tribal Governments 76563 6380 0

RESOURCE REPORT No Health Health Care Services
CMS-10028 Resorurce Report Yes Yes Fillable Fileable Form and instruction Resource_Report_Form_112409_508Certified.pdf
State, Local, and Tribal Governments 54 108 0

2013-06-10-04:00

0938-0857 201312-0938-019 0938
             
        "Recognition of Pass-Through Payment for Additional (New) Categories of Devices Under the Outpatient Prospective Payment System and Supporting Regulations (CMS-10052)"
             
          
        
Information is necessary to determine eligibility of medical devices for establishment of additional device categories for payment under transitional pass-through payment provisions as required by section 1833(t)(6) of the Social Security Act. 2017-02-28-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 10 160 0

Recognition of pass-through payment for additional (new) categories of devices under the Outpatient Prospective Payment System and Supporting Regulations (CMS-10052) No Health Health Care Services Private Sector 10 160 0

2014-02-06-05:00

0938-0860 201103-0938-004 0938
             
        "Recognition of Payment for New Technology Services for Ambulatory Payment Classifications (APCs) under the Outpatient Propsective Payment System and Supporting...."
             
          
        
Information is necessary to determine services eligible for payment in new technology ambulatory payment classifications (APCs) in the outpatient prospective payment system. 2014-04-30-04:00 Active Eulanda Grigg 410 786-7202 No No No 15 180 0

Recognition of payment for new technology services for ambulatory payment classification (APC) groups under the Outpatient Prospective Payment System and Supporting Regulations in 42 CFR, Part 419 No Health Health Care Services Private Sector 15 180 0

2011-04-11-04:00

0938-0866 201303-0938-017 0938
             
        "ICRs Contained in 45 CFR Part 162; HIPAA Standards for Electronic Transactions"
             
          
        
This submission contains information collection requirements in HCFA-0149-F, CMS-0003-P, CMS-0005-P, and CMS-003/005-F. The collection standardizes the approximately 400 formats of electronic health care claims used in the United States. The use of these standards significantly reduces the administrative burden associated with paper documents, lowers operating costs, and improves data quality for health care providers and health plans. 2016-06-30-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 6960260 6960260 0

ICRs Contained in 45 CFR Part 162; HIPAA Standards for Electronic Transactions No Health Health Care Services Private Sector 6960260 6960260 0

2013-06-10-04:00

0938-0878 201308-0938-015 0938
             
        "Collection of Diagnostic Data from Medicare Advantage Organizations for Risk Adjusted Payments Supporting Reg 42 CFR Part 422 & 423 Subparts F and G"
             
          
        
CMS requires hospital inpatient, hospital outpatient and physician diagnostic data from Medicare Advantage organizations to continue making payment under the risk adjustment methodology as required by the Social Security Act of 1967 as amended by the Balanced Budget Act of 1997; the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000; and the Medicare Prescription Drug Benefit, Improvement and Modernization Act of 2003. 2016-09-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 82830000 40650 0

Collection of Diagnostic Data from Medicare Advantage Organizations for Risk Adjusted Payments Supporting Reg 42 CFR Part 422 & 423 Subparts F and G No Health Health Care Services Private Sector 82830000 40650 0

2013-09-20-04:00

0938-0880 201312-0938-001 0938
             
        "Medicare Waiver Demonstration Application"
             
          
        
This application provides an opportunity for eligible organizations to apply to participate in Medicare-waiver-only demonstrations sponsored by the Centers for Medicare & Medicaid Services (CMS). CMS conducts Medicare-waiver-only demonstrations to test innovations that have been shown to be successful in improving access and quality and/or lowering health care costs. 2017-02-28-05:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 75 6000 0

Medicare Waiver Demonstration Application No Health Health Care Services
CMS-10069 Medicare Waiver Demonstration Ajpplication Yes Yes Fillable Fileable Form and instruction CMS-10069_Medicare_Demo_Waiver_App (Non-substantive changes).docx
Private Sector 75 6000 0

2014-02-06-05:00

0938-0887 201303-0938-015 0938
             
        "Matching Gants to States for the Operation of High Risk Pools and Supporting Regulations at 42 CFR 148.316, 148.318, and 148.320 *CMS-10078)"
             
          
        
CMS is requiring this information as a condition of eligibility for grants that were authorized in the Trade Act of 2002 (PL 107-210), the Deficit Reduction Act of 2005 (P.L. 109-171) and the State High Risk Pool Funding Extension Act of 2006 (P.L. 109-172). The information is necessary to determine if a state applicant meets the necessary eligibility criteria for a grant as required by the law. The respondents will be states that have a high risk pool as defined in Section 2741, 2744, or 2745 of the Public Health Service Act. The grants will provide funds to states that incur losses in the operation of high risk pools. High risk pools are set up by states to provide heatlh insurance to individuals that cannot obtain health insurance in the private market because of a history of illness. 2016-06-30-04:00 Active James Mayhew james.mayhew@cms.hhs.gov 301 492-4113 No Yes No 31 1240 0

Matching Gants to States for the Operation of High Risk Pools and Supporting Regulations at 42 CFR 148.316, 148.318, and 148.320 No Health Health Care Services State, Local, and Tribal Governments 31 1240 0

2013-06-10-04:00

0938-0897 201307-0938-028 0938
             
        "Notification of FIs and CMS of co-located Medicare providers and Supporting Regulations in 42 CFR 412.22 and 412.533"
             
          
        
Many long-term care hospitals (LTCHs) are co-located with other Medicare providers (acute care hospitals, IRFs, SNFs, psychiatric facilities), which leads to potential gaming of the Medicare system based on patient shifting. CMS is requiring LTCHs to notify fiscal intermediaries K (FIs), Medicare Administrative Contractors (MACs) and CMS of co-located providers in order to establish policies to limit payment abuse that will be based on FIs tracking patient movement among these co-located providers. 2016-09-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 25 6 0

Notification of FIs and CMS of co-Located Medicare Providers and Supporting Regulations No Health Health Care Services Private Sector 25 6 0

2013-09-26-04:00

0938-0907 201302-0938-011 0938
             
        "Hospital Wage Index Occupational Mix Survey and Supporting Regulations in 42 CFR, Section 412.64"
             
          
        
Section 304 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 requires CMS to collect wage data on hospital employees by occupational category, at least once every 3 years, in order to construct an occupational mix adjustment to the wage index. CMS first collected occupational mix data in 2003 for the FY 2005 wage index and a subsequent collection of occupational mix data was performed in 2006 for the FY 2007 and FY 2008 wage index. In response to industry comments suggesting ways to improve the occupational mix survey, CMS has revised the 2007/2008 survey that was used to calculate the FY 2010 wage index. We are revising the 2007/2008 survey to collect for a 12- month period (that is, from pay periods ending between January 1, 2010 and December 31, 2010). The revised occupational mix survey will be used to adjust the FY 2013 wage index. 2016-05-31-04:00 Active William Parham 4107864669 No No No 3500 1680000 0

Hospital Wage Index Occupational Mix Survey and Supporting Regulations in 42 CFR, Section 412.64 No Health Health Care Services
CMS-10079 Hospital Wage Index Occupational Mix Survey Yes Yes Fillable Fileable Form and instruction 2013 MEDICARE WAGE INDEX OCCUPATIONAL MIX SURVEY_2-12-13update.docx
Private Sector 3500 1680000 0

2013-05-14-04:00

0938-0916 201305-0938-018 0938
             
        "Paid Feeding Assistants in Long Term Care Facilities and Supporting Regulations at CFR 42 483.160"
             
          
        
42 CFR 483 permits long-term care facilities to use paid feeding assistants to supplement the services of certified nurse aides. If facilities choose this option, feeding assistants must complete a specified training program. In addition, a facility must maintain a record of all individuals, used by the facility as feeding assistants, who have successfully completed the training course for paid feeding assistants. This information is used as part of the process to determine facility compliance with this requirement. 2016-07-31-04:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 4250 25500 0

Paid Feeding Assistants in Long Term Care Facilities and Supporting Regulations Contained in 42 CFR 483.160 No Health Health Care Services Private Sector 4250 25500 0

2013-07-26-04:00

0938-0920 201307-0938-018 0938
             
        "Medicaid Managed Care and Supporting Regulations"
             
          
        
These information collections requirements implement regulations that allow states greater flexibility to implement mandatory managed care programs, implement new beneficiary protections, and eliminate certain requirements viewed by state agencies as impediments to the growth of managed care programs. Information collected includes information about managed care programs, grievances and appeals, enrollment broker contracts, and managed care organizations capacity to provide health care services. 2016-09-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 9813796 1797823 0

Medicaid Managed Care Regulations (States) 42 CFR 438.6, 438.10, 438.50, 438.202, 438.722, 438.724, and 438.810 No Health Health Care Services Private Sector 3521368 313925 0

Medicaid Managed Care Regulations (Private Sector) 42 CFR 438.8, 438.10, 438.12, 438.102, 438.207, 438.208, 438.210, 438.236, 438.240, 438.242, 438.404, and 438.416 No Health Health Care Services State, Local, and Tribal Governments 6292428 1483898 0

Medicare Managed Care Regulations (CMS-10108) No Health Health Care Services Individuals or Households 0 0 0

2013-09-26-04:00

0938-0921 201112-0938-002 0938
             
        "Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations"
             
          
        
In accordance with Section 1847A of the Social Security Act (the Act), Medicare Part B covered drugs and biologicals not paid on a cost or prospective payment basis are paid based on the average sales price of manufacturers' average sales price data submitted to the Centers for Medicare & Medicaid Services (CMS). The reporting requirements are specified in 42 CFR Part 414 Subpart J. In the CY2005 IFC, we published information about the ASP reporting requirements for Medicare Part B drugs and biologicals (66 FR 17935) and specified that manufacturers must report the ASP data using our Addendum A template. We also initiated additional changes to the template in 2008 (73 FR 76032). In order to facilitate more accurate and consistent ASP data reporting from manufacturers, we are now proposing revisions to the Addendum A template. Specifically, we propose to revise existing reporting fields and add new fields to the Addendum A template, as follows: o To split the current NDC column into three separate reporting fields, corresponding to the three segments of an NDC: the labeler, product, and trade package size; o To add a new field to collect an Alternate ID for products without an NDC; and o To expand the current FDA approval number column to account for multiple entries and supplemental numbers. We have also added a macro to the Addendum A template that will allow manufacturers to validate the format of their data prior to submission. This will help verify that data are complete and submitted to CMS in the correct format, thereby minimizing time and resources spent on identifying mistakes or errors. A User Guide containing general instructions on the use of the template and instructions for the reporting of dermal grafting products has also been created. 2015-03-31-04:00 Active William Parham 4107864669 No No No 720 34560 0

Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110) No Health Health Care Services
Yes No Printable Only Instruction LabelerTemplate Users Guide_DRAFT for approval.pdf CMS-10110 Average Sales Price (ASP) Addendum A Yes Yes Fillable Printable Form TestASPAddendumAMacro_DRAFT for approval.xlsm
Private Sector 720 34560 0

2012-03-23-04:00

0938-0926 201307-0938-002 0938
             
        "In-Center Hemodialysis CAHPS Survey"
             
          
        
Administration of In-center Hemodialysis CAHPS(ICH CAHPS) survey by more than 5,700 Medicare-certified ESRD facilities is now required as part of the value-based purchasing program for payments under the Medicare program, as described in the 2012 proposed and final ESRD Prospective System Payment Update Rules published in the Federal Register on July 8, 2011, and November 10, 2011, respectively. Value-based purchasing promotes CMS' goals: better healthcare for individuals; better care for populations and communities; and, lower costs through improvement. Beginning in CY2014, ICH facilities will be required to contract with a CMS-approved survey vendor to implement the survey; the CMS-approved vendor shall follow a set of standardized survey administration procedures developed for national implementation. Survey results from the national implementation will be publicly reported on the DFC website on www.medicare.gov. 2016-09-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 325000 87750 0

In-Center Hemodialysis CAHPS Survey: Mode No Health Health Care Services
CMS-10105 Attachment E - Telephone Script (English and Spanish) No No Printable Only Form Attachment E - ICH CAHPS Telephone Script (English and Spanish).docx CMS-10105 Attachment C - Final ICH CAHPS Survey (English and Spanish) Yes No Fillable Printable Form Attachment C - Final ICH CAHPS Survey (English and Spanish).docx
Individuals or Households 5000 1350 0

In-Center Hemodialysis CAHPS Survey: National Implementation No Health Health Care Services
CMS-10105 Attachment E - Telephone Script (English and Spanish) No No Printable Only Form Attachment E - ICH CAHPS Telephone Script (English and Spanish).docx CMS-10105 Attachment C - Final ICH CAHPS Survey (English and Spanish) No No Fillable Printable Form Attachment C - Final ICH CAHPS Survey (English and Spanish).docx
Individuals or Households 320000 86400 0

2013-09-20-04:00

0938-0929 201307-0938-009 0938
             
        "FEDERAL REIMBURSEMENT OF EMERGENCY HEALTH SERVICES FURNISHED TO UNDOCUMENTED ALIENS (SECTION 1011) PROVIDER ENROLLMENT APPLICATION"
             
          
        
THIS INFORMATION COLLECTION ALLOWS HOSPITALS, PHYSICIANS AND AMBULANCE PROVIDERS TO ENROLL TO RECEIVE SECTION 1011 PAYMENT, AND ALLOWS ENROLLED PROVIDERS TO MAKE CHANGES TO THEIR CONTACT INFORMATION OR TO DISENROLL FROM THE PROGRAM. THE INFORMATION PROVIDED ON THIS APPLICATION IS USED BY THE CENTERS FOR MEDICARE & MEDICAID SERVICES TO ENSURE PROGRAM PAYMENTS ARE MADE ONLY TO ELIGIBLE PROVIDERS, TO DETERMINE/VERIFY APPLICANT PARTICIPATION IN OTHER FEDERAL PROGRAMS, AND TO IDENTIFY/VERIFY THE EXISTENCE OF ANY PROVIDER SANCTIONS THAT WOULD PRECLUDE THE APPLICANT FROM PARTICIPATING IN A FEDERAL PROGRAM. 2016-09-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 10000 4998 0

FEDERAL REIMBURSEMENT OF EMERGENCY HEALTH SERVICES FURNISHED TO UNDOCUMENTED ALIENS (SECTION 1011) PROVIDER ENROLLMENT APPLICATION (CMS-10115) No Health Health Care Services
CMS-10115 Section 1011 Provider Enrollment Application Yes No Fillable Printable Form and instruction CMS-10115 - CLEAN.docx
Private Sector 10000 4998 0

2013-09-26-04:00

0938-0930 201103-0938-014 0938
             
        "Medicare Authorization to Disclose Personal Health Information"
             
          
        
Unless permitted or required by law, the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule prohibit covered entities from disclosing an individual's protected health information to a third party without a valid privacy authorization. The authorization must include specified core elements and certain statements. Medicare beneficiaries will use the "Medicare Authorization to Disclose Personal Health Information" to authorize Medicare to diclose their protected health information to a third party. 2014-05-31-04:00 Active Eulanda Grigg 410 786-7202 No No No 1004000 251000 0

Medicare Authorization to Disclose Personal Health Information No Health Health Care Services
OMB no. 0938-0930 Medicare Authorization to Disclose Personal Health Information No No Fillable Fileable Form and instruction clean fillableauthform_v1 1d_02022011.docx No No Paper Only Instruction clean Information to Help You Fill Out the.docx
Individuals or Households 1004000 251000 0

2011-05-06-04:00

0938-0931 201111-0938-014 0938
             
        "National Provider Identifier (NPI) Application and Update Form and Supporting Regs in 45 CFR 142.408, 45 CFR 162.408, 45 CFR 162.406"
             
          
        
The form will be used by health care providers to apply for NPIs and to update the information collected from them whenever it changes. 2015-03-31-04:00 Active William Parham 4107864669 No No No 195839 65280 0

National Provider Identifier (NPI) Application and Update Form and Supporting Regs in 45 CFR 142.408, 45 CFR 162.408, 45 CFR 162.406 No Health Health Care Services
CMS-10114 NPI Application/Update Form Yes Yes Fillable Printable Form and instruction DRAFT - Revised CMS-10114 (08082011 without watermark).pdf
Private Sector 53040 17680 0

National Provider Identifier (NPI) Application and Update Form No Health Health Care Services
CMS-10114 NPI Application/Update Form Yes Yes Fillable Printable Form and instruction DRAFT - Revised CMS-10114 (08082011 without watermark).pdf
Private Sector 142799 47600 0

2012-03-29-04:00

0938-0933 201102-0938-014 0938
             
        "1932 State Plan Amendment Template, State Plan Requirements, and Supporting Regulations in 42 CFR 438.50 (CMS-10120)"
             
          
        
The State Medicaid Agencies will complete the template. CMS will review the information to determine if the state has met all the requirements under 1932(a)(1)(A) and 42 CFR 438.50. Once the all the requirements are met, the state will be allowed to enroll Medicaid beneficiaries on a mandatory basis into managed care entities without section 1115 or 1915(b) waiver authority. 2014-03-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 10 100 0

1932 State Plan Amendment Template, State Plan Requirements, and Supporting Regulations in 42 CFR 438.50 No Health Health Care Services
CMS-10120 1932 State Plan Amendment Template Yes Yes Fillable Fileable Form and instruction CMS-10120 SPA-051004.doc
State, Local, and Tribal Governments 10 100 0

2011-03-24-04:00

0938-0935 201211-0938-007 0938
             
        "Medicare Advantage Application  - Part C and  1876 Cost Plan Expansion Application regulations under 42 CFR 422 subpart K & 417.400"
             
          
        
In order to provide health benefits to Medicare beneficiaries under the Medicare Advantage Program and/or the 1876 Cost Plan, applicant must meet regulatory requirements to enter into a contract with CMS, or to continue to contract with CMS. The revised Part C application is created to capture the applicants' information. 2015-12-31-05:00 Active William Parham 4107864669 No Yes No 566 21581 0

Part C Medicare Advantage Applications and 1876 Cost Plan Expansion Application (CY 2012) No Health Health Care Services
CMS-10237 CY 2014 HSD Exception Request Template Yes Yes Fillable Fileable Form and instruction 508_CY 2014 HSD Exception Request Template 5-24-12(30 day)(clean).pdf CMS-10237 MA Provider Table CY 2014 Yes Yes Fillable Fileable Form 508_CMS MA Provider Table CY 2014 (30day)(Clean)0906112 (2).pdf CMS-10237 .PartC MA and Cost Plan Applications Yes Yes Fillable Fileable Form and instruction 508_CY2014 PartC MA and Cost Plan Applications09-17-2012 30 day.pdf CMS-10237 MA Facility Table 2014 Yes Yes Fillable Fileable Form 508_Copy of CMS MA Facility Table 2014(clean)(30-day)(final).pdf Yes Yes Fillable Fileable Instruction 508_CY 2014 HSD Instructions 09-13-12(30day)(final draft).pdf
Private Sector 566 21581 0

2012-12-20-05:00

0938-0936 201310-0938-010 0938
             
        "Solicitation for Applications for Medicare Prescription Drug Plan 2015 Contracts"
             
          
        
The Applications for Part D sponsors to offer qualified prescription drug coverage are completed by entities seeking approval to offer Part D benefits under the Medicare Prescription Drug Benefit program established by section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and is codified in section 1860D of the Social Security Act (the Act). 2015-01-31-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 254 2319 0

Solicitation for Applications for Medicare Prescription Drug Plan 2015 Contracts No Health Health Care Services
CMS-10137 Solicitation for Applications for Medicare Prescription Drug Plan 2015 Contracts Yes Yes Fillable Printable Form and instruction 2015 Part D Application_v draft_09222013_508 Compliant.pdf CMS-10137 Medicare Part D Application for New PACE Organizations (2014 Contract Year) Yes Yes Fillable Printable Form and instruction 2014 Application for New PACE_v.draft 092214_508 Compliant.pdf
Private Sector 254 2319 0

2014-01-15-05:00

0938-0941 201205-0938-008 0938
             
        "Medicare Demonstration Ambulatory Care Quality Measure Performance Assessment Tool ("PAT") "
             
          
        
The Performance Assessment Tool ("PAT) is being used to collect clinical quality measure information. It is not an electronic health record but rather a tool for collecting 'numerator' and 'denominator' information that is used to calculate performance measures on specific clinical quality measures. The tool is currently approved for use in the Physician Group Practice Demonstration (PGP), a congressionally mandated demonstration that will continue data collection past the current expiration date and through September 2013. 2015-07-31-04:00 Active William Parham 4107864669 No No No 10 790 0

Medicare Demonstration Ambulatory Care Quality Measure Performance Assessment Tool (PAT) - MCMP Demonstration No Health Health Care Services
CMS-10136 MCMP PAT Yes Yes Paper Only Form and instruction MCMP PAT Screenshots 052508(B).ppt
Private Sector 0 0 0

Medicare Demonstration Ambulatory Care Quality Measure Performance Assessment Tool (PAT) - PGP Demonstration No Health Health Care Services
CMS-10136 PGP_TD-PAT_Screen_ShotsJH Yes Yes Fillable Fileable Form and instruction PGP_TD-PAT_Screen_ShotsJH.pdf CMS-10136 PGP_TD-PAT_Screen_Shots_050312 updated Yes Yes Fillable Fileable Form and instruction
Private Sector 10 790 0

Medicare Demonstration Ambulatory Care Quality Measure Performance Assessment Tool (PAT) -EHR Demonstration No Health Health Care Services
CMS-10136 MCMP PAT Yes Yes Paper Only Form and instruction MCMP PAT Screenshots 052508(B).ppt
Private Sector 0 0 0

2012-07-16-04:00

0938-0944 201312-0938-016 0938
             
        "Bid Pricing Tool (BPT) for Medicare Advantage (MA) Plans and Prescription Drug Plans (PDP)"
             
          
        
Under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), and implementing regulations at 42 CFR, Medicare Advantage organizations (MAO) and Prescription Drug Plans (PDP) are required to submit an actuarial pricing "bid" for each plan offered to Medicare beneficiaries for approval by the Centers for Medicare & Medicaid Services (CMS). MAOs and PDPs use the Bid Pricing Tool (BPT) software to develop their actuarial pricing bid. The information provided in the BPT is the basis for the plan's enrollee premiums and CMS payments for each contract year. 2015-02-28-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 4995 149850 0

CY 2013 Bid Pricing Tool (BPT) for Medicare Advantage (MA) Plans and Prescription Drug Plans (PDP)-CMS-10142 No Health Health Care Services
CMS-10142 Bid Pricing Tool (BPT) for Medicare Advantage (MA) Plans Yes Yes Fillable Printable Form CMS-10142_Attachment_D-1_CY2015_MA_BPT.pdf CMS-10142 Bid Pricing Tool (BPT) for Prescription Drug Plans (PDP) Yes Yes Fillable Printable Form CMS-10142_Attachment_D-2_CY2015_PD_BPT.pdf Yes No Printable Only Instruction CMS-10142_Attachment_E-2_CY2015_PD_BPT_Instructions.pdf Yes No Printable Only Instruction CMS-10142_Attachment_E-1_CY2015_MA_BPT_Instructions.pdf
Private Sector 4995 149850 0

2014-02-06-05:00

0938-0950 201208-0938-004 0938
             
        "Appointment of Representative and Supporting Regulations in 42 CFR 405.910"
             
          
        
This form will be completed by beneficiaries, providers and suppliers who wish to appoint representatives to assist them with obtaining initial determinations and filing appeals. The appointment of representative form must be signed by the party making the appointment and the individual agreeing to accept the appointment. 2015-06-30-04:00 Active William Parham 4107864669 No No No 265481 66370 0

Appointment of Representative and Supporting Regulations in 42 CFR 405.910 (Beneficiary) No Health Health Care Services
CMS-1696 Appointment of Representative Yes No Fillable Fileable Form and instruction CMS-1696.Instrument (6-7-12).pdf CMS-1696 Appointment of Representative (Spanish Version) Yes No Fillable Fileable Form and instruction 1696version508_Spanish.docx
Individuals or Households 26548 6637 0

Appointment of Representative and Supporting Regulations in 42 CFR 405.910 (Provider Supplier) No Health Health Care Services
CMS-1696 Appointment of Representative Yes No Fillable Fileable Form and instruction CMS-1696.Instrument (6-7-12).pdf CMS-1696 Appointment of Representative (Spanish Version) Yes No Fillable Fileable Form and instruction 1696version508_Spanish.docx
Private Sector 238933 59733 0

2012-08-13-04:00

0938-0951 201312-0938-004 0938
             
        "Collection of Drug Pricing and Network Pharmacy Data from Medicare Prescription Drug Plans (PDP and MA-PD) and Supporting Regulations in 42 CFR 423.48"
             
          
        
Both stand alone prescription drug plans (PDPs) and Medicare Advantage Prescription Drug (MA-PDs) plans will be required to submit drug pricing and pharmacy network data to CMS. These data will be made publicly available to people with Medicare through the Medicare prescription drug plan finder tool on www.medicare.gov. The purpose of the data is to enable people with Medicare to compare, learn, select and enroll in a plan that best meets their needs. 2017-02-28-05:00 Active William Parham 4107864669 No No No 17680 70720 0

Collection of Drug Pricing and Network Pharmacy Data from Medicare Prescription Drug Plans (PDP and MA-PD) and Supporting Regulations in 42 CFR 423.48 No Health Health Care Services
CMS-10150 2014 Pricing Data Guidelines Yes Yes Fillable Fileable Form and instruction 2014 Pricing Data Guidelines 07.2013.pdf
Private Sector 17680 70720 0

2014-02-06-05:00

0938-0952 201307-0938-008 0938
             
        "Federal Funding of Emergency Health Services (Section 1011); Provider Payment Determination and On-Call Cost Forms"
             
          
        
THE "SECTION 1011 PROVIDER PAYMENT DETERMINATION" FORM ALLOWS HOSPITALS, PHYSICIANS AND AMBULANCE PROVIDERS TO ASCERTAIN AND DOCUMENT A PATIENT'S ELIGIBILITY STATUS UNDER SECTION 1011 OF THE MMA. THE FORM IS MAINTAINED BY THE PROVIDER AS DOCUMENTATION OF PATIENT ELIGIBILITY, FOR PAYMENT AND RELATED POLICY DETERMINATIONS AND IS USED BY THE CENTERS FOR MEDICARE & MEDICAID SERVICES TO ENSURE PROGRAM PAYMENTS ARE MADE ONLY FOR ELIGIBLE PATIENTS. THE "REQUEST FOR SECTION 1011 HOSPITAL ON-CALL PAYMENTS TO PHYSICIANS" FORM ALLOWS HOSPITALS TO CALCULATE AND REQUEST FEDERAL REIMBURSEMENT UNDER SECTION 1011 OF THE MMA FOR ON-CALL PAYMENTS MADE TO PHYSICIANS. THE FORM IS SUBMITTED BY THE PROVIDER ON A QUARTERLY BASIS TO THE CENTERS FOR MEDICARE & MEDICAID SERVICES FOR REIMBURSEMENT. 2016-09-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 300148 75007 0

Federal Funding of Emergency Health Services (Section 1011) Provider Payment Determination (CMS-10130A) No Health Health Care Services
CMS-10130 SECTION 1011 PROVIDER PAYMENT DETERMINATION Yes Yes Fillable Printable Form and instruction CMS-10130A.pdf
Private Sector 300000 74970 0

Federal Funding of Emergency Health Services;Request for Section 1011 Hospital On-call Payments to Physicians (CMS-10130B) No Health Health Care Services
CMS-10130 Request for Section 1011 Hospital On-Call Payments to Physicians Yes Yes Fillable Printable Form and instruction CMS-10130B.pdf
Private Sector 148 37 0

2013-09-26-04:00

0938-0953 201112-0938-003 0938
             
        "Notice of Provider Non-Coverage (CMS-10123) and Detailed Explanation of Non-Coverage (CMS-10124)"
             
          
        
The Notice of Medicare Provider Non-Coverage (CMS-10123) is used to inform fee-for-service Medicare beneficiaries of the determination that their provider services will end, and of their right to an expedited review of that determination. The Detailed Explanation of Non-Coverage (CMS-10124) is used to provide beneficiaries who request an expedited determination with detailed information of why the services should end. 2014-12-31-05:00 Active William Parham 4107864669 No No No 5339849 927931 0

Expedited Review Notices and Supporting Regulations Contained in 42 CFR SEction 405.1200 and 405.1202 No Health Health Care Services
CMS-10123 Notice of Medicare Non-Coverage Yes No Fillable Fileable Form CMS10123spanish.docx CMS-10123 Notice of Medicare Non-Coverage Yes No Fillable Fileable Form 508_NOMNCcombined508.pdf Yes No Fillable Fileable Instruction 508_NOMNCcombinedinstructions508.pdf
Private Sector 5314194 885699 0

Notice of Provider Non-Coverage (CMS-10123) and Detailed Explanation of Non-Coverage (CMS-10124) No Health Health Care Services
Yes No Fillable Fileable Instruction 508_DENC combinednstructions508.pdf CMMS-10124 Detailed Explanation of Non-coverage Yes No Fillable Fileable Form 508_DENCcombined508.pdf CMS-10124 Detailed Explanation of Non-coverage Yes No Fillable Fileable Form CMS10124spanish.docx
Individuals or Households 25655 42232 0

2011-12-15-05:00

0938-0957 201311-0938-027 0938
             
        "Retiree Drug Subsidy (RDS) Application and Instructions"
             
          
        
Under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and implementing regulations at 42 CFR ?423 Subpart R, Plan Sponsors e.g., employers or unions) that offer prescription drug coverage to their qualifying covered retirees are eligible to receive a 28% tax-free subsidy for allowable drug costs. In order to qualify, a Plan Sponsor must submit a complete application to CMS with a list of retirees for whom it intends to collect the subsidy 2017-02-28-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 4500 288000 0

Private Sector - Retiree Drug Subsidy (RDS) Application and Instructions No Health Health Care Services
Yes No Printable Only Instruction CMS10156ApplicationInstructions.pdf CMS-10156 RDS Application Yes Yes Fillable Printable Form CMS10156RDSApplication.pdf
Private Sector 3000 192000 0

Public - Retiree Drug Subsidy (RDS) Application and Instructions (CMS-10156) No Health Health Care Services
CMS-10156 RDS Application Yes Yes Fillable Printable Form CMS10156RDSApplication.pdf Yes No Printable Only Instruction CMS10156ApplicationInstructions.pdf
State, Local, and Tribal Governments 1500 96000 0

2014-02-06-05:00

0938-0958 201212-0938-002 0938
             
        "Monthly State File of Medicaid/Medicare Dual Eligible Enrollees (CMS-10143)"
             
          
        
The monthly file of dual eligible enrollees will be used to determine those duals with drug benefits for the phased down State contribution process required by the Medicare Modernization Act of 2003 (MMA). 2016-01-31-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 612 6120 0

Monthly State File of Medicaid/Medicare Dual Eligible Enrollees No Health Health Care Services State, Local, and Tribal Governments 612 6120 0

2013-01-08-05:00

0938-0964 201312-0938-021 0938
             
        "Medicare Prescription Drug Benefit Program"
             
          
        
The voluntary prescription drug benefit program was enacted into law on December 8, 2003 in section 101 of Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The MMA specifies that the prescription drug benefit program will be available to beneficiaries on January 1, 2006. Coverage for the prescription drug benefit will be provided under private prescription drug plans, or through Medicare Advantage prescription drug plans. Organizations offering drug plans will have flexibility in the design of the prescription drug benefit. 2017-02-28-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 46099845 7572223 0

Medicare Prescription Drug Benefit Program (Benes) No Health Health Care Services Individuals or Households 10015000 2897950 0

Medicare Prescription Drug Benefit Program (PLAN)-(CMS-10141) No Health Health Care Services
CMS-10141 Compensation Structure for Writing Agents by Contract/PBP Number Yes Yes Fillable Printable Form CMS-10141.Attachment_4_(Agent_Compensation_Information_Workbook)-2013 Part D PRA.xls Yes Yes Paper Only Other CMS-10141.Attachments 1a-1b (Certifications)-11-07-08.doc Yes Yes Paper Only Instruction CMS-10141.Attachments 5a-5c (Instructions)-11-07-08.doc Yes Yes Paper Only Other CMS-10141.Attachments 2a-2b (Structure Submission Form)-11-07-08.doc CMS-10141 Writing Agents Information Sheet Yes Yes Fillable Printable Form CMS-10141.Attachment_3_(Covered_Agent_Information_Sheets_Workbook)2013 Part D.xls
Private Sector 35484743 4661013 0

State Eligibility Determinations [423.904(b)] and Reporting [423.910(d)] No Health Health Care Services State, Local, and Tribal Governments 600102 13260 0

2014-02-06-05:00

0938-0967 201308-0938-018 0938
             
        "Data Collection for Medicare Beneficiaries Receiving Implantable Cardioverter-defibrillators for Primary Prevention of Sudden Cardiac Death"
             
          
        
To encourage responsible and appropriate use of ICDs, CMS issued a Decision Memo for Implantable Defibrillators on January 27, 2005, indicating that ICDs will be covered for primary prevention of sudden cardiac death if the beneficiary is enrolled in either an FDA-approved category B IDE clinical trial (42 DFR ?405.201), a trial under the CMS Clinical Trial Policy (NCD Manual ?310.1) or a qualifying prospective data collection system (either a practical clinical trial or prospective systematic data collection, which is sometimes referred to as a registry). 2016-09-30-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 20424 139656 0

Data Collection for Medicare Beneficiaries Receiving Implantable Cardioverter-defibrillators for Primary Prevention of Sudden Cardiac Death No Health Health Care Services
Yes No Fillable Fileable Instruction ICDDataDictionaryv1 0.pdf CMS-10151 CMS-10151 Instrument Yes Yes Fillable Fileable Form ICD_v2_DataCollectionForm_GenLeads_2 1_508 compliant.pdf
Private Sector 20424 139656 0

2013-09-20-04:00

0938-0968 201303-0938-013 0938
             
        "Data collection for Medicare Beneficiaries Receiving FDG Positron Emission Tomography (PET) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and All Other Cancers "
             
          
        
In the Decision Memo #CAG-00181N issued on January 27, 2005, CMS determined that the evidence is sufficient to conclude that for Medicare beneficiaries receiving FDG positron emission tomography (PET) for brain, cervical, ovarian, pancreatic, small cell lung, and testicular cancers is reasonable and necessary only when the provider is participating in and patients are enrolled in a systematic data collection project. CMS will consider prospective data collection systems to be qualified if they provide assurance that specific hypotheses are addressed and they collect appropriate data elements. The data collection should include baseline patient characteristics; indications for the PET scan; PET scan type and characteristics; FDG PET results; results of all other imaging studies; facility and provider characteristics; cancer type, grade, and stage; long-term patient outcomes; disease management changes; and anti-cancer treatment received. 2016-05-31-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 50000 4167 0

Collection for Medicare Bene#s Receiving FDG Positron Emissions Tomography for Brain, Cervical, Ovarian, Small Cell Lung, and Testicular Cancers No Health Health Care Services
CMS-10152 NOPR referring_md_sheet Yes Yes Fillable Fileable Form NOPR referring_md_sheet.pdf CMS-10152 PET Facility Registration Form Yes Yes Fillable Fileable Form 0938-0968 Form 1.pdf CMS-10152 Case Registration Form Yes Yes Fillable Fileable Form 0938-0968 Form 2.pdf CMS-10152 Pre-PET Form Yes Yes Fillable Fileable Form 0938-0968 Form 3.pdf CMS-10152 Restaging Form Post-Scan Yes Yes Fillable Fileable Form 0938-0968 Form 10.docx CMS-10152 Treatment Monitoring Form-Post Scan Yes Yes Fillable Fileable Form 0938-0968 Form 9.docx CMS-10152 Initial Staging Form Yes Yes Fillable Fileable Form 0938-0968 Form 8.docx CMS-10152 Diagnosis of Suspected Osseous Mestasis Form-Post Scan Yes Yes Fillable Fileable Form 0938-0968 Form 7.docx CMS-10152 Interpreting Physician Scan Assessment Form Yes Yes Fillable Fileable Form 0938-0968 Form 6.pdf CMS-10152 Report Submission Form Yes Yes Fillable Fileable Form 0938-0968 Form 5.pdf CMS-10152 PET Completion Form Yes Yes Fillable Fileable Form 0938-0968 Form 4.pdf
Private Sector 50000 4167 0

2013-05-22-04:00

0938-0969 201210-0938-005 0938
             
        "Medicare Fee-for-Service Early Review of Medical Records"
             
          
        
The information required under this collection is requested by Medicare contractors to determine proper payment or if there is a suspicion of fraud. Medicare contractors request the information form providers or suppliers submitting claims for payment from the Medicare program when data analysis indicates aberrant billing patterns or other information which may present a vulnerability to the Medicare program. 2015-10-31-04:00 Active William Parham 4107864669 No No No 2220434 1105109 0

Probe Review (Provider Specific) No Health Health Care Services Individuals or Households 23400 11700 0

Probe Review (Serivce Specific) No Health Health Care Services Individuals or Households 156600 78300 0

Prepayment Review No Health Health Care Services Individuals or Households 2020000 1010000 0

Attestation No Health Health Care Services Individuals or Households 20434 5109 0

2012-10-31-04:00

0938-0974 201309-0938-009 0938
             
        "Payment Error Rate Measurement in Medicaid and the State Children Health Insurance Program"
             
          
        
Improper Payments Information Act (IPIA) of 2002 requires CMS to produce national error rates for Medicaid and SCHIP. To comply with the IPIA, CMS needs the information to be collected from States and providers in order to sample and review adjudicated claims in a randomly selected number of States. Based on the reviews, State-specific error rates will be calculated which will be calculated which will serve as the basis for calculating national error rates for Medicaid and SCHIP. 2016-10-31-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 34 56100 0

Payment Error Rate Measurement in Medicaid and the State Children Health Insurance Program No Health Health Care Services
CMS-10166 IPIA Yes Yes Fillable Printable Form IPIA.pdf CMS-10166 CAP SHO Letter No No Fillable Fileable Form and instruction CAP SHO Letter FINAL to OMB 090407.doc
State, Local, and Tribal Governments 34 56100 0

2013-10-23-04:00

0938-0975 201203-0938-003 0938
             
        "Standardized Pharmacy Notice: Your Prescription Cannot be Filled (f/k/a Medicare Prescription Drug Coverage and Your Rights) "
             
          
        
Pursuant to 42 C.F.R. ? 423.562(a)(3) and ? 423.128(b)(7)(iii), Part D plan sponsors must arrange with their network pharmacies to provide a printed copy of the standardized pharmacy notice to enrollees (beneficiaries) at the point of sale when an enrollee's prescription cannot be filled. 2015-01-31-05:00 Active William Parham 4107864669 No No No 37087402 617876 0

Standardized Pharmacy Notice No Health Health Care Services
CMS-10147 CMS-10147.Pharnacy Notice - Spanish Version Yes Yes Fillable Fileable Form CMS-10147.Spanish Version.pdf Yes Yes Fillable Fileable Instruction Instructions_CMS 2010147_10 2018 2011 Clean.docx CMS-10147 CMS-10147_Pharmacy_Notice_ Yes Yes Fillable Fileable Form CMS-10147_Pharmacy_Notice_(clean).pdf
Private Sector 37087402 617876 0

2012-03-12-04:00

0938-0976 201312-0938-013 0938
             
        "Notice of Denial of Medicare Prescription Drug Coverage"
             
          
        
Pursuant to 42 CFR 423.568(c) and (d), if a Part D plan denies drug coverage it must give the enrollee written notice of the adverse coverage determination. The form and content of the written denial notice must comport with specific requirements, including a description of the appeals process. Pursuant to a 2009 change in regulations at 423.580 and 423.582, a prescriber may now request a standard redetermination (plan level appeal) on behalf of an enrollee. It is necessary to incorporate this change in the description of the appeals process contained on the Notice of Denial of Medicare Prescription Drug Coverage. 2016-11-30-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 1497929 374527 0

Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146 and 10146SP) No Health Health Care Services
CMS-10146(SP) Notice of Denial of Medicare Prescription Drug Coverage Yes No Fillable Printable Form and instruction Denial Notice Spanish2013v508.pdf
Private Sector 1497929 374527 0

2014-02-12-05:00

0938-0978 201008-0938-009 0938
             
        "Coordination of Benefits between Part D Plans and Other Prescription Coverage Providers"
             
          
        
This information is necessary to assist with coordination of prescription drug benefits provided to the Medicare beneficary at the pharmacy. 2014-02-28-05:00 Active Bonnie Harkless 4107865666 No No No 248018 754788 0

Coordination of Benefits between Part D Plans and Other Prescription Coverage Providers (CMS-10171) No Health Health Care Services Private Sector 248018 754788 0

2010-11-23-05:00

0938-0981 201204-0938-008 0938
             
        "National Implementation of Hospital Consumer Assessment of Health Providers and Systems (HCAHPS) CMS-10102"
             
          
        
The intent of the HCAHPS initiative is to provide a standardized survey instrument and data collection methodology for measuring patients' perspectives on hospital care. While many hospitals collect information on patient satisfaction, there is no national standard for collecting or publicly reporting this information that would enable valid comparisons to be made across all hospitals. 2015-07-31-04:00 Active William Parham 4107864669 No Yes No 2713812 365145 31748403

National Implementation of Hospital Consumer Assessment of Health Providers and Systems (HCAHPS) No Health Health Care Services
CMS-10102 Appendix B Yes Yes Fillable Fileable Form and instruction CMS-10102_Supporting_Statement_Part_A_(Appendix_B).pdf CMS-10102 Appendix A Yes Yes Fillable Fileable Form and instruction CMS-10102_Supporting_Statement_Part_A_(Appendix_A).pdf CMS-10102 Appendix C Yes Yes Fillable Fileable Form and instruction CMS-10102_Supporting_Statement_Part_A_(Appendix_C).pdf
Individuals or Households 2710000 361333 16500403

National Implementation of Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) CMS-10102 No Health Health Care Services
CMS-10102 Appendix B Yes Yes Fillable Fileable Form and instruction CMS-10102_Supporting_Statement_Part_A_(Appendix_B).pdf CMS-10102 Appendix C Yes Yes Fillable Fileable Form and instruction CMS-10102_Supporting_Statement_Part_A_(Appendix_C).pdf CMS-10102 Appendix A Yes Yes Fillable Fileable Form and instruction CMS-10102_Supporting_Statement_Part_A_(Appendix_A).pdf
Private Sector 3812 3812 15248000

2012-07-02-04:00

0938-0983 201302-0938-010 0938
             
        "Medicare EDI Enrollment Form and EDI Registration"
             
          
        
Federal law requires that CMS minimize the security risk to federal information systems. CMS is requiring that trading partners who wish to conduct the Electronic Data Interchange (EDI) transactions provide certain assurance as a condition of receiving access to the Medicare system for the purpose of conducting EDI exchanges. Health care providers, clearinghouses, and health plans that wish access to the Medicare system are required to complete this form. The information will be used to assure that those entities that access the Medicare system are aware of applicable provisions and penalties. 2016-06-30-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 240000 80000 0

Medicare EDI Enrollment Form and EDI Registration No Health Health Care Services
CMS-10164 Accessible EDI Enrollment Form Yes Yes Fillable Fileable Form and instruction CMS-10164_EDI_ENROLL(8-8-12).pdf CMS-10164 Accesible EDI Registration Form Yes Yes Fillable Fileable Form and instruction CMS-10164_Medicare_EDI_Registration_(7-31-12)_v2.pdf
Private Sector 240000 80000 0

2013-06-10-04:00

0938-0986 201206-0938-010 0938
             
        "Rehabilitation Unit Criteria Work Sheet and Rehabilitation Hospital Criteria Work Sheet and Supporting Regulations at 42 CFR 412.20-412.30 (CMS-437A&B)"
             
          
        
The rehabilitation hospital and rehabilitation unit criteria work sheets are necessary to verify that these facilities/units comply and remain in compliance with the exclusion criteria for the Medicare perspective payment system. 2015-08-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 1164 291 0

Rehabilitation Unit Criteria Work Sheet and Rehabilitation Hospital Criteria Work Sheet and Supporting Regulations at 42 CFR 412.20-412.30 (CMS-437A&B) No Health Health Care Services
CMS-437B Rehabilitation Hospital Criteria Worksheet Yes No Printable Only Form and instruction CMS437B.pdf CMS-437A Rehabilitiation Unit Criteria Worksheet Yes No Printable Only Form and instruction CMS437A.pdf
Private Sector 1164 291 0

2012-08-31-04:00

0938-0988 201309-0938-030 0938
             
        "Children's Health Insurance Program (CHIP) Report on Payables and Receivables"
             
          
        
The Chief Financial Officers Act of 1990, as amended by the Government Management and Reform Act of 1994, requires government agencies to produce auditable financial statements. Form CMS-10180 will collect accounting data from the States on Payables and Receivables. 2017-01-31-05:00 Active William Parham 4107864669 No No No 56 392 0

Children's Health Insurance Program (CHIP) Report on Payables and Receivables No Health Health Care Services
No No Fillable Printable Instruction CMS-10180 Validation Letter.doc CMS-10180 IBNR No No Fillable Fileable Form CMS-10180 Revised Form (2011).doc
State, Local, and Tribal Governments 56 392 0

2014-01-23-05:00

0938-0992 201308-0938-014 0938
             
        "Medicare Part D Reporting Requirements under 42 CFR section 423.505"
             
          
        
MMA provides CMS the statutory authority to require all Part D Sponsors (MA-PDs and PDPs) to report data related to their operational costs and services. These data will be analyzed for oversight and monitoring purposes, as well as potentially initiating other groups within the agency to perform functions such as fraud/waste/abuse investigations, audit activities, and compliance. Title I, Part 423, ?423.514 describes CMS' regulatory authority to establish reporting requirements for Part D sponsors. It is noted that each Part D plan sponsor must have an effective procedure to develop, compile, evaluate, and report to CMS, to its enrollees, and to the general public, at the times and in the manner that CMS requires, statistics in the following areas: (1) The cost of its operations. (2) The patterns of utilization of its services. (3) The availability, accessibility, and acceptability of its services. (4) Information demonstrating that the Part D plan sponsor has a fiscally sound operation. (5) Other matters that CMS may require. Subsection 423.505 of the MMA regulation establishes as a contract provision that Part D Sponsors must comply with the reporting requirements for submitting drug claims and related information to CMS. 2016-09-30-04:00 Active William Parham 4107864669 No No No 8067 12658 577466

Medicare Part D Reporting Requirements (CMS-10185) No Health Health Care Services
CMS-10185 Medicare Part D Reporting Requirements Yes Yes Fillable Fileable Form and instruction CMS-10185 - CY2014_Part D Reporting Requirements_Draft 2_07152013.docx
Private Sector 8067 12658 577466

2013-09-20-04:00

0938-0994 201308-0938-029 0938
             
        "Payment Error Rate Measurement in Medicaid & Children's Health Insurance Program (CHIP)"
             
          
        
Payment Error Rate Measurement (PERM) is established to comply with Improper Payment Information Act (IPIA) of 2002. The program measures improper payments in both Medicaid and State Children's Health Insurance Program (SCHIP). Each PERM cycle will measure payment errors in 17 randomly selected states, so that each state will be measured once every three years. PERM measure three components in each program: fee-for-service, managed care, and eligibility. The payment error in the three components will be combined to calculate an annual payment error rate in Medicaid and CHIP. 2016-10-31-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 28050 28050 0

Medicaid and Children's Health Insurance Plan (CHIP) Managed Care No Health Health Care Services State, Local, and Tribal Governments 28050 28050 0

2013-10-23-04:00

0938-0997 201303-0938-010 0938
             
        "Medicare Uniform Institutional Provider Bill and Supporting Regulations in 42 CFR 424.5"
             
          
        
This standardized form is used in the Medicare/Medicaid program to apply for reimbursement of covered services by all providers that accept Medicare/Medicaid assigned claims and that do not bill Medicare and Medicaid electronically. 2016-05-31-04:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 181909654 1567455 0

Medicare Uniform Institutional Provider Bill and Supporting Regulations in 42 CFR 424.5 No Health Health Care Services
CMS-1450 (UB04) Uniform Institutional Providers Form Yes Yes Fillable Fileable Form CMS-1450 UB04-front.pdf Yes Yes Fillable Fileable Instruction CMS-1450 UB04 - Back.pdf
Private Sector 181909654 1567455 0

2013-05-22-04:00

0938-0999 201211-0938-010 0938
             
        "Insurance Common Claims Form and Supporting Regulations at 42 CFR Part 424 Subpart C"
             
          
        
This form is a standardized claim form foruse in the Medicare/ Medicaid programs to apply for reimbursement for covered services Many private insurers also use this form. Use of this form reduces cost and administrative burdens associated with professional claims because only one format need be used and maintained. 2016-05-31-04:00 Active William Parham 4107864669 No No No 988005045 21481336 0

Insurance Common Claims Form and Supporting Regulations at 42 CFR Part 424 Subpart C No Health Health Care Services
CMS-1500(08-05) Health Insurance Claim Form Yes Yes Fillable Fileable Form and instruction CMS1500(08-05).pdf CMS-1490-S PATIENT'S REQUEST FOR MEDICAL PAYMENT Yes Yes Fillable Fileable Form and instruction CMS1490S English.pdf
Private Sector 988005045 21481336 0

2013-05-15-04:00

0938-1000 201307-0938-024 0938
             
        "Medicare Parts C and D Universal Audit Guide"
             
          
        
42 CFR 422.502 describes CMS' regulatory authority to evaluate, through inspection or other means, Medicare Advantage Part C organizations. These records include books, contracts, medical records, patient care documentation and other records that pertain to any aspect of services performed, reconciliation of benefit liabilities, and determination of amounts payable. 42 CFR 423.503 states that CMS must oversee a Part D plan sponsor's continued compliance with the requirements for a Part D plan sponsor. 423.514 states that the Part D plan sponsor must have an effective procedure to develop, compile, evaluate, and report to CMS, to its enrollees, and to the general public, at the times and in the manner that CMS requires, statistics regarding areas such as cost of operations, patterns of utilization availability, accessibility, and acceptability of services. CMS developed a strategy to address our oversight and audit responsibilities within the context of limited audit/oversight resources. We intend to combine all Part C and Part D guides into one universal guide as it will promote efficiency and effectiveness and reduce financial and time burdens for both CMS and Medicare-contracting entities. 2016-12-31-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 195 23595 0

Medicare Parts C and D Universal Audit Guide No Health Health Care Services
Yes No Printable Only Instruction Attachment VII ODAG Audit Process and Universe Request--REDUCED.pdf CMS-10191 Self Disclosure Report Yes Yes Fillable Printable Form Attachment VI -Self Disclosure Report--REDUCED.pdf Yes No Printable Only Instruction Attachment VIII - 2013 Audit Process Document--REDUCED.pdf Yes Yes Printable Only Other Attachment X - A - OEV Universe Template--REDUCED.pdf Yes No Printable Only Instruction Attachment X - OEV Protocol Audit Process and Universe Request--REDUCED.pdf Yes No Printable Only Instruction Medicare_Part_C__Part_D_Universal_Audit_Guide_07_10_13 CLEAN--REDUCED [rev 11-13-2013 by OSORA PRA].pdf Yes No Printable Only Instruction 2.13.13 - 2013 CPE Attachment III -Data and Document Request [rev 7-21-13 by OSORA PRA]--REDUCED.pdf Yes No Printable Only Instruction 2-2013 12-21-12-Attachment III-A Sample Case File Documentation--REDUCED.pdf CMS-10191 Key Contacts for Compliance Program Operations Yes Yes Fillable Printable Form 3-2013 12-21-12-Attachment III-B Compliance Program Contacts--REDUCED.pdf Yes No Printable Only Other 4-2013 12-21-12-Attachment IV Organization Governance Template--REDUCED.pdf CMS-10191 CPE SELF-ASSESSMENT QUESTIONNAIRE Yes Yes Fillable Printable Form 5-2013 12-21-12-Attachment V - CPE Self-Assessment Questionnaire--REDUCED.pdf Yes Yes Printable Only Other Att IX-A - SNP MOC Universe Template--REDUCED.pdf Yes No Printable Only Instruction Attachment I - FA Audit Process and Universe Request--REDUCED.pdf Yes Yes Printable Only Other Attachment I-A - FA Universe Template--REDUCED.pdf Yes No Printable Only Instruction Attachment II - CDAG Audit Process and Universe Request--REDUCED.pdf Yes Yes Printable Only Other Attachment II-A - CDAG Universe Template--REDUCED.pdf Yes No Printable Only Instruction Attachment IX - SNP MOC Audit Process and Universe Request--REDUCED.pdf Yes No Printable Only Instruction Attachment I-B - FA Sample Case Minimum Documentation Required--REDUCED.pdf Yes Yes Fillable Printable Other Attachment VII-A - ODAG Universe Template --REDUCED.pdf
Private Sector 195 23595 0

2013-12-13-05:00

0938-1012 201310-0938-003 0938
             
        "Payment Error Rate Measurement - State Medicaid and CHIP Eligibility"
             
          
        
The Improper Payments Information Act (IPIA) of 2002 requires CMS to produce national error rates for Medicaid and SCHIP. To comply with the IPIA, CMS needs the information to be collected in order to provide some Federal overview of state eligibility determinations to ensure correctness and consistency among states and to use the State-specific error rates as the basis for calculating national eligibility error rates for Medicaid and SCHIP. 2017-02-28-05:00 Active Kayla Williams Kayla.Williams@cms.hhs.gov 410 786-5887 No No No 1583 946164 0

Payment Error Rate Measurement - State Medicaid and CHIP Eligibility No Health Health Care Services
CMS-10184 PERM Review Summary and Instructions Yes Yes Fillable Printable Form and instruction PERM Review Summary and Instructions final.pdf Yes Yes Printable Only Instruction PETT_UserGuide_January2013.pdf
State, Local, and Tribal Governments 34 34000 0

Payment Error Rate Measurement - State Medicaid and CHIP Eligibility No Health Health Care Services
CMS-10184 CMS-10184.FINAL-PERM Eligibility Error Rate Forms Yes No Fillable Printable Form CMS-10184.FINAL-PERM Eligibility Error Rate Forms-10-30-06.doc Yes No Printable Only Instruction CMS-10184.PERM Form Instructions-10-30-06.DOC
State, Local, and Tribal Governments 408 40800 0

Payment Error Rate Measurement - State Medicaid and CHIP Eligibility No Health Health Care Services
Yes No Printable Only Instruction CMS-10184.PERM Form Instructions-10-30-06.DOC CMS-10184 CMS-10184.FINAL-PERM Eligibility Error Rate Forms Yes No Fillable Printable Form CMS-10184.FINAL-PERM Eligibility Error Rate Forms-10-30-06.doc
State, Local, and Tribal Governments 34 324870 0

Payment Error Rate Measurement - State Medicaid and CHIP Eligibility No Health Health Care Services
Yes No Printable Only Instruction CMS-10184.PERM Form Instructions-10-30-06.DOC CMS-10184 CMS-10184.FINAL-PERM Eligibility Error Rate Forms Yes No Fillable Printable Form CMS-10184.FINAL-PERM Eligibility Error Rate Forms-10-30-06.doc
State, Local, and Tribal Governments 408 40800 0

Payment Error Rate Measurement - State Medicaid and CHIP Eligibility No Health Health Care Services
Yes No Printable Only Instruction CMS-10184.PERM Form Instructions-10-30-06.DOC CMS-10184 CMS-10184.FINAL-PERM Eligibility Error Rate Forms Yes No Fillable Printable Form and instruction CMS-10184.FINAL-PERM Eligibility Error Rate Forms-10-30-06.doc
State, Local, and Tribal Governments 408 40800 0

Payment Error Rate Measurement - State Medicaid and CHIP Eligibility No Health Health Care Services
Yes No Printable Only Instruction CMS-10184.PERM Form Instructions-10-30-06.DOC CMS-10184 CMS-10184.FINAL-PERM Eligibility Error Rate Forms Yes No Fillable Printable Form CMS-10184.FINAL-PERM Eligibility Error Rate Forms-10-30-06.doc
State, Local, and Tribal Governments 34 3400 0

Payment Error Rate Measurement - State Medicaid and CHIP Eligibility No Health Health Care Services
CMS-10184 CMS-10184.FINAL-PERM Eligibility Error Rate Forms Yes No Fillable Printable Form CMS-10184.FINAL-PERM Eligibility Error Rate Forms-10-30-06.doc Yes No Printable Only Instruction CMS-10184.PERM Form Instructions-10-30-06.DOC
State, Local, and Tribal Governments 34 34000 0

Payment Error Rate Measurement - State Medicaid and CHIP Eligibility (MEQC Substitution) No Health Health Care Services
CMS-10184B Detailed Active Case Review Findings Yes Yes Fillable Fileable Form and instruction CMS 10184B MEQC substitution 7-8-09.doc CMS-10184A Cases Selected for Review: Monthly Sample Selection List Yes Yes Fillable Fileable Form and instruction CMS 10184A MEQC substitution 7-8-09.doc CMS-10184E Summary Findings Yes Yes Fillable Fileable Form and instruction CMS 10184E MEQC substitution 7-8-09.doc CMS-10184 Negative Case Review Findings No No Fillable Fileable Form and instruction 10184 Negative Case Review Findings.pdf
State, Local, and Tribal Governments 19 407094 0

Reinstatement of Prior Burden Estimates for CMS-10184E No Health Health Care Services
CMS 10184 CMS-10184 Yes Yes Fillable Fileable Form and instruction PERM Review Summary and Instructions final.pdf 101814E CMS-10184 Yes No Fillable Fileable Form and instruction 10184 PERM Eligibility Review Findings new.pdf
State, Local, and Tribal Governments 204 20400 0

2014-02-06-05:00

0938-1013 201312-0938-006 0938
             
        "Creditable Coverage Disclosure to CMS OnLine Form and Instructions"
             
          
        
Information collection requirements will ensure that entities that currently provide prescription drug benefits to any Medicare Part D eligible individual disclose to CMS whether the prescription drug benefit that they offer is creditable coverage. The disclosure is required to be provide annually and upon any change that affects whether the coverage is creditable prescription drug coverage. This collection also provides creditable coverage disclosure instructions for entities complying with these infromation collection request. 2017-02-28-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 86744 7364 0

Federal - Creditable Coverage Disclosure to CMS OnLine Form and Instructions No Health Health Care Services
CMS-10198 Creditable Coverage Disclosure to CMS Yes Yes Fillable Printable Form and instruction CC Disclosure to CMS Instructions and Screen Shots Clean 0938-1013 CMS 10198final.pdf
Federal Government 87 7 0

Private Sector - Creditable Coverage Disclosure to CMS OnLine Form and Instructions No Health Health Care Services
CMS-10198 Creditable Coverage Disclosure to CMS Yes Yes Fillable Printable Form and instruction CC Disclosure to CMS Instructions and Screen Shots Clean 0938-1013 CMS 10198final.pdf
Private Sector 83864 7125 0

State, Local, or Tribal Governments - Creditable Coverage Disclosure to CMS OnLine Form and Instructions No Health Health Care Services State, Local, and Tribal Governments 2793 232 0

2014-02-12-05:00

0938-1016 201305-0938-005 0938
             
        "Requests for Bids (RFB) for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program"
             
          
        
In preparing for the Round 2 and national mail-order competitions, CMS received OMB approval of this collection on November 2, 2011 with no material or non-substantive changes. The collection was modified from prior rounds of competitive bidding in order to make the documents more reader-friendly, to clarify the requirements that suppliers had difficulty in understanding, and to incorporate the Round 2 and national mail order bidding areas and product categories. CMS is currently re-competing the Round 1 Rebid areas. On 10/10/12, we received approval for a revision to a currently approved collection to extend the information collection for an additional three years. We are seeking OMB approval for a revision to this currently approved package as our program expands and increases the population from which we will be collecting information. 2016-06-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 20212 9301 0

Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program; Application for Suppliers (Form A) No Health Health Care Services
CMS-10169 Application for Suppliers Yes Yes Fillable Fileable Form and instruction Form A_ 2012 30-day notice.docx
Private Sector 0 0 0

Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program; Bidding Form (Form B) No Health Health Care Services
CMS-10169 Form B - Bidding Form Yes Yes Fillable Fileable Form and instruction Form B_2012.docx
Private Sector 0 0 0

Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program; Quarterly Reporting Form (Form C) No Health Health Care Services
CMS-10169 Form C: QUARTERLY REPORT No No Fillable Fileable Form and instruction Form C screenshot FINAL-SuppDirConceptv2Default.pdf
Private Sector 4952 1651 0

Round 1 Re-Compete for the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program; Beneficiary Survey (Form D) No Health Health Care Services
CMS-10169 Beneficiary Survey Yes Yes Fillable Fileable Form and instruction Form D_2012.docx
Individuals or Households 14667 7333 0

Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program; Subcontracting Disclosure No Health Health Care Services
CMS-10169 CONTRACT SUPPLIER'S DISCLOSURE OF SUBCONTRACTORS Yes Yes Fillable Fileable Form and instruction Subcontracting screenshot FINAL.PDF
Private Sector 390 160 0

Change of Ownership (CHOW) Contract Supplier Notification Form No Health Health Care Services
CMS-10169 Change of Ownership (CHOW) Contract Supplier Notification Form Yes Yes Fillable Fileable Form and instruction Change of Ownership Supplier Notification Form.pdf
Private Sector 92 46 0

Change of Ownership (CHOW) Purchaser Form No Health Health Care Services
CMS-10169 Change of Ownership (CHOW) Purchaser Form Yes Yes Fillable Fileable Form and instruction Change of Ownership Purchaser Form.pdf
Private Sector 111 111 0

2013-06-10-04:00

0938-1019 201305-0938-015 0938
             
        "Medicare and Medicare Advantage Programs; Notification Procedures for Hospital Discharges Detaile"
             
          
        
Based on a settlement agreement of the Weichardt vs. Leavitt class action suit, CMS-4105-F sets forth new requirements for how hospitals must notify Medicare beneficiaries who are hospital inpatients about their hospital discharge rights. Pursuant to sections 405.1206 and 422.622, hospitals and Medicare Advantage plans must deliver to beneficiaries and enrollees, who are appealing inpatient hospital discharges, a detailed notice providing the reasons for the discharge decision. Notice is required both for original Medicare beneficiaries and for beneficiaries enrolled in Medicare Advantage plans and other Medicare health plans subject to the MA regulations. 2016-07-31-04:00 Active William Parham 4107864669 No No No 12852 12852 0

Medicare and Medicare Advantage Programs; Notification Procedures for Hospital Discharges Detailed Notice of Discharge (CMS-10066) No Health Health Care Services
CMS-10066 Detailed Notice of Discharge (Spanish Language Version) No No Paper Only Form and instruction SpanishDetailedNoticeofDischarge2013v508.pdf CMS-10066 Detailed Notice of Discharge No No Paper Only Form and instruction 508_DetailedNoticeofDischarge2013v508.pdf
Private Sector 12852 12852 0

2013-07-26-04:00

0938-1022 201210-0938-002 0938
             
        "Additional Quality Measures and Procedures for Hospital Reporting of Quality Data for the FY 2008 IPPS Annual Payment Update (Surgical Care Improvement Project & Mortality Measures)"
             
          
        
The Hospital Inpatient Quality Reporting Program (IQR) program was first established to implement section 5001(b) of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) (Pub. L. 108-173), which authorized CMS to pay hospitals that successfully reported quality measures a higher annual update to their payment rates. It builds on a voluntary Inpatient Quality Reporting program which remains in effect. The Hospital IQR program formerly known as the Reporting Hospital Quality Data for Annual Payment Update program, began with an initial set of 10 measures. Section 5001(a) of the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109-171) revised the mechanism used to update the standardized amount for payment for hospital inpatient operating costs. This is reflected in Sections 1886(b)(3)(B)(viii)(I) and (II) of the Social Security Act which provide that the annual payment update (APU) will be reduced for any "subsection (d) hospital" that does not submit certain quality data in a form and manner, and at a time, specified by the Secretary. Section 5001(a) of the DRA also expanded the scope of IQR, requiring CMS to add new measures. Sections 1886(b)(3)(B)(viii)(III) through (V) of the Social Security Act, required CMS to "adopt the baseline set of performance measures as set forth in the November 2005 report by the Institute of Medicine of the National Academy of Sciences", instructed the Secretary to "add other measures that reflect consensus among affected parties", and allowed the Secretary to "replace any measures or indicators in appropriate cases". When adding new measures, the law required CMS when "feasible and practical" to select measures put forward by "one or more national consensus building entities". 2016-03-31-04:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No Yes No 17600 6750000 0

Additional Quality Measures and Procedures for Hospital Reporting of Quality Data for the FY 2008 IPPS Annual Payment Update (Surgical Care Improvement Project & Mortality Measures) No Health Health Care Services
CMS-10210 Notice of Participation Yes No Fillable Printable Form and instruction CMS-10210.Draft Notice of Participation.doc CMS-10210 Qnet Yes Yes Fillable Fileable Form praqnet.doc CMS-10210 Oryx Yes Yes Fillable Fileable Form praoryx.doc CMS-10210 Cart Summary Yes No Fillable Fileable Form cartsumm.doc CMS-10210 HIPAA Compliance Yes Yes Fillable Fileable Form HIPAA Compliance - SDPS_QualityNet 091806.doc
Private Sector 0 0 0

Additional Quality Measures and Procedures for Hospital Reporting of Quality Data for the FY 2008 IPPS Annual Payment Update (Surgical Care Improvement Project & Mortality Measures) No Health Health Care Services
CMS-10210 Cart Summary Yes No Fillable Fileable Form cartsumm.doc CMS-10210 Oryx Yes Yes Fillable Fileable Form praoryx.doc CMS-10210 Notice of Participation Yes No Fillable Fileable Form and instruction CMS-10210.Draft Notice of Participation.doc CMS-10210 HIPAA Compliance Yes Yes Fillable Fileable Form HIPAA Compliance - SDPS_QualityNet 091806.doc CMS-10210 Qnet Yes Yes Fillable Fileable Form praqnet.doc
Private Sector 0 0 0

Quality Measures and Procedures for Hospital Reporting of Quality Data No Health Public Health Monitoring
CMS-10210 Extroadinary Circumstance Paper Yes Yes Fillable Fileable Form and instruction ExtraordinaryCircumstance_Paper Form.docx CMS-10210 Reconsideration Request Part 2 Yes Yes Fillable Fileable Form and instruction Recon Request_Part 2.doc CMS-10210 Decline to Participate Yes Yes Fillable Fileable Form and instruction Decline_Participate_Form.doc CMS-10210 Data Accuracy and Completeness Yes Yes Fillable Fileable Form and instruction Decline_Participate_Form.doc CMS-10210 Notice of Participation Yes Yes Fillable Fileable Form and instruction Notice of Participation.docx CMS-10210 HAI Exception Online Yes Yes Fillable Fileable Form and instruction HAI Exception Online Form.pdf CMS-10210 HAI Exception Paper Yes Yes Fillable Fileable Form and instruction HAI Exception_Paper Form.docx CMS-10210 Hospital Data Validation Yes Yes Fillable Fileable Form and instruction HospValidAppeal_Paper Part1.docx CMS-10210 Reconsideration Request Online Yes Yes Fillable Fileable Form and instruction ReconsiderationRequest Online Form.pdf CMS-10210 Reconsideration Request Paper Yes Yes Fillable Fileable Form and instruction ReconsiderationRequestPaper Form.docx CMS-10210 Extroadinary Circumstance Online Yes Yes Fillable Fileable Form and instruction Extraordinary Circumstance Online Form.pdf
Private Sector 17600 6750000 0

2013-03-20-04:00

0938-1023 201111-0938-008 0938
             
        "Chronic Care Improvement Program and Medicare Advantage Quality Improvement Project"
             
          
        
The Social Security Act, ?1852 e(1), (2) and (3)(a)(i), and regulations at Part 42, ?422.152 describe CMS' regulatory authority to require each Medicare Advantage Organization (MAO) coordinated care plan that offers one or more MA plans to have an ongoing quality assessment and performance improvement program. This program must include measuring performance using standard measures required by the Centers for Medicare and Medicaid Services (CMS), and report its performance to CMS. 2014-06-30-04:00 Active William Parham 4107864669 No No No 1904 28560 0

Chronic Care Improvement Program and Medicare Advantage Quality Improvement Project No Health Health Care Services
CMS-10209 QIP_Reporting_Tool Yes Yes Fillable Fileable Form and instruction CMS-10209_QIP_Reporting_Tool_Final.pdf No Printable Only Instruction CMS-10209.CCIP User Guide (05-31-2012).docx No Printable Only Instruction CMS-10209.QIP User Guide for OMB 05-31-12.docx CMS-10209 CCIP_Reporting_Tool Yes Yes Fillable Fileable Form and instruction CMS-10209_CCIP_Reporting_Tool _Final.pdf
Private Sector 1904 28560 0

2012-06-21-04:00

0938-1027 201312-0938-012 0938
             
        "PACE State Plan Amendment Pre-print (CMS-10227)"
             
          
        
The Balanced Budget Act of 1997 created Section 1934 of the Social Security Act that established the Program for the All-Inclusive Care for the Elderly (PACE). The legislation established the PACE program as a Medicaid State plan option serving the frail and elderly in the home and community. Pursuant to the notice given in 64 FR 66271 (November 24, 199), if a State elects to offer PACE as an optional Medicaid benefit, it must complete a State Plan Amendment described as Enclosures 3, 4, 5, 6 and 7. The information, collected by CMS on a one-time basis, is used by CMS to affirm that the State elects to offer PACE as an optional State plan service and the specifications of eligibility, payment and enrollment for the program. 2017-02-28-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 7 140 0

PACE State Plan Option Preprint (CMS-10227) No Health Health Care Services
No No Printable Only Instruction SMDL-11-09-00.tif CMS-10227 PACE State Plan Amendment Pre-Print No No Fillable Printable Form CMS-10227 SPA PACE PREPRINT.doc
State, Local, and Tribal Governments 7 140 0

2014-02-06-05:00

0938-1028 201009-0938-020 0938
             
        "Healthcare Effectiveness Data and Information Set (HEDIS)  Data Collection for Medicare Advantage"
             
          
        
CMS has a responsibility to its Medicare beneficiaries to ensure that care provided by Medicare Advantage (MA) contracts to CMS is of high quality and conforms to currently acceptable standards of medical care. CMS accomplishes this through the collection, analysis and dissemination of HEDIS data, the most widely used standardized clinical performance measurement set in managed care. Since January 1997, Medicare managed care contracts have been required to annually report quality of care performance measures from HEDIS. In April 1997, CMS began working with NCQA to implement HEDIS data collection directly into the Medicare managed care program. It is critical to the agency's mission that CMS continues to collect and disseminate information that will help beneficiaries choose among health plans; information that contributes to better health care through the identification of quality improvement opportunities; and provides for proper oversight and management of the Medicare program. These data are used in external CMS information products issued to beneficiaries, and are published on the CMS public website. These data are also made publicly available through public use files (PUFs) posted on the CMS website. CMS relies heavily on HEDIS data for contractor surveillance and assessment activities. It is critical to the agency's mission that CMS continues to collect and disseminate information that will help beneficiaries choose among health plans; information that contributes to better health care through the identification of quality improvement opportunities; and provides for proper oversight and management of the Medicare program. 2014-02-28-05:00 Active Bonnie Harkless 4107865666 No No No 483 154560 7245000

HEDIS Information Collection Request (CMS-10219) No Health Health Care Services Private Sector 483 154560 7245000

2010-12-20-05:00

0938-1029 201206-0938-004 0938
             
        "Worksheet for Recording Results of Medicare Site Visits of Independent Diagnostic Testing Facilities (IDTFs)"
             
          
        
The Independent Diagnostic Testing Facilities (IDTF) - Site Investigation form was developed and implemented to allow for CMS to have a standard format to collect and verify information regarding the compliance of independent diagnostic testing facilities (IDTFs) with the performance standards found in 42 CFR ? 410.33(g). This previously approved form was allowed to expire in error. CMS is now seeking re-instatement of the use of this form. 2015-08-31-04:00 Active William Parham 4107864669 No No No 2000 4000 0

Worksheet for Recording Results of Medicare Site Visits of Independent Diagnostic Testing Facilities (IDTFs) No Health Health Care Services
CMS-10221 IDTF Worksheet Yes No Fillable Fileable Form and instruction CMS-10221.IDTF WORKSHEET.DOC
Private Sector 2000 4000 0

2012-08-08-04:00

0938-1033 201012-0938-014 0938
             
        "Medicaid State Program Integrity (SPIA) CMS-10244"
             
          
        
Under the provisions of the Deficit Reduction Act (DRA) of 2005, Congress directed the Centers for Medicare & Medicaid Services (CMS) to establish the Medicaid Integrity Program (MIP), CMS' first national strategy to combat Medicaid fraud, waste, and abuse. CMS has two broad responsibilities under the MIP: 1) Reviewing the actions of individuals or entities providing services or furnishing items under Medicaid; conducting audits of claims submitted for payment; identifying overpayments; and educating providers and others on payment integrity and quality of care; and 2) Providing effective support and assistance to States to combat Medicaid fraud, waste, and abuse. In order to fulfill the second of these requirements, CMS developed the Medicaid State Program Integrity Assessment (SPIA). CMS uses SPIA to collect data on State Medicaid program integrity activities, develop reports for each State based on these data, determine areas to provide States with technical support and assistance, andevelop measures to assess States' performance. CMS is seeking an extension of the approval from the Office of Management and Budget (OMB) to annually collection information from the States through SPIA. 2014-02-28-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 56 1400 0

Medicaid State Program Integrity Assessment (SPIA) CMS-10244 No Health Health Care Services
CMS-10244 Medicaid State Program Integrity Assessment (SPIA) Yes No Fillable Fileable Form and instruction Appendix B - SPIADataCollectionInstrument.pdf Yes No Printable Only Other Appendix C - SPIA Glossary.pdf
State, Local, and Tribal Governments 56 1400 0

2011-02-27-05:00

0938-1034 201012-0938-010 0938
             
        "Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR  489.20"
             
          
        
Section 6001(a) of the Patient Protection and Affordable Care Act (the ACA) amended section 1877(d)(2) and (d)(3) of the Act to impose additional restrictions in order to qualify for the rural provider and whole hospital exceptions under the physician self-referral law. Among those restrictions were provisions requiring hospitals to prevent conflicts of interest by disclosing physician ownership or investment interest to patients and also requiring hospitals to take certain steps to ensure patient safety. 2014-03-31-04:00 Active William Parham 4107864669 No Yes No 52391536 1281469 0

Requirements in 42 CFR 489.20(u)(1) - (Atttorney) No Health Health Care Services Private Sector 265 1060 0

Requirements in 42 CFR 489.20(u)(1) - (Inpatient) No Health Health Care Services Private Sector 289380 4823 0

Requirements in 42 CFR 489.20(u)(1) - (Outpatient) No Health Health Care Services Private Sector 4630080 77168 0

Requirements in 411.362(b)(5)(i) and 489.20(w)(2) - Attorney No Health Health Care Services Private Sector 2557 10228 0

Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Inpatient) No Health Health Care Services Private Sector 2792244 69806 0

Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 489.20 (Outpatient) No Health Health Care Services Private Sector 44675904 1116898 0

Disclosures to Patients by Certain Hospitals and Critical Access Hospitals and Supporting Regulations in 42 CFR 489.20 (Hospital Disclosure) No Health Health Care Services Private Sector 10 1 0

Physician-ownership of hospitals - medical staff by-laws/policites -411.362(b)(3)(ii)(A) and 489.20(u)(2) No Health Health Care Services Private Sector 265 530 0

Physician-ownersip of hospitals - physician disclosure (411.362(b)(3)(ii)9A) No Health Health Care Services Private Sector 10 1 0

Inapplicability of Hospital Disclosure -- 489.20(u)(1) No Health Health Care Services Private Sector 26 26 0

website/public advertising disclosure-- 411.362(b)(3)(ii)(C) and 489.20(u)(1)(ii) No Health Health Care Services Private Sector 265 398 0

Physician-ownership of hospitals - patient disclosure and staff physician disclosure No Health Health Care Services Private Sector 530 530 0

2011-03-14-04:00

0938-1041 201203-0938-002 0938
             
        "Survey of Retail Prices: Payment and Utilization Rates, and Performance Rankings"
             
          
        
This revision request is for a survey of the average acquisition costs of all covered outpatient drugs purchased by retail community pharmacies. The prices will be updated on at least a monthly basis. 2015-05-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 30051 15765 0

Annual State Report and Annual State Performance Rankings (CMS-10241) No Health Health Care Services
CMS-10241 Annual State Report and Annual State Performance Ranking Yes Yes Fillable Fileable Form and instruction Copy of CMS-10241-CMSStatesAnalysisdatacollectiontemplate v4(PART I).xls
State, Local, and Tribal Governments 51 765 0

Survey of Retail Community Pharmacy Invoice Prices No Health Health Care Services
1 NADAC Survey Tool Yes Yes Fillable Printable Form and instruction NADAC Survey Tool 5-1-12 CLEAN (2)lr (2)lr (2).docx Yes No Fillable Printable Other Survey Cover Sheet.docx Yes No Fillable Printable Instruction Dear Pharmacy Owner Letter 5-1-12 CLEAN.docx
Private Sector 30000 15000 0

2012-05-11-04:00

0938-1042 201104-0938-008 0938
             
        "Healthcare Common Procedure Coding System (HCPCS) - Level II Code Modification Request Process"
             
          
        
The information on this form is used to update the HCPCS code set. All information is received and distributed to CMS' HCPCS workgroup and is reviewed and discussed at monthly workgroup meetings. In turn, CMS' HCPCS workgroup reaches a decision as to whether a change should be made to codes in the HCPCS code set. The respondent who submits the application form can be anyone who has an interest in obtaining a code or modifying an exiting code. However, respondents are usually manufacturers of products, or consultants on behalf of the manufacturer. 2014-07-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 300 3300 0

Healthcare Common Procedure Coding System (HCPCS) - Level II Code Modification Request Process No Health Health Care Services
CMS-10224 Healthcare Common Procedure Coding System (HCPCS) Level II Code Set Form (2013) Yes No Fillable Printable Form and instruction 2013 HCPCS Application.doc CMS-10224 Healthcare Common Procedure Coding System (HCPCS) Level II Code Set (2012) Yes No Fillable Printable Form and instruction CMS-10224 2012 HCPCS Update Application-8-17-10.doc
Private Sector 300 3300 0

2011-07-24-04:00

0938-1043 201011-0938-004 0938
             
        "Conditions of Participation for Critical Access Hospitals and Supporting Regulations in 42 CFR 485.23, 485.618, 485.618, 485.631, 485.635, 485.641, 485.643, 485.645"
             
          
        
With this submission, we are revising the PRA package for critical access hospitals (CAHs) to include the new requirement associated with 42 CFR 485.635(f). 2014-03-31-04:00 Active William Parham 4107864669 No No No 143994 23615 0

42CFR485.623(d)(4) No Health Health Care Services Private Sector 1189 595 0

42CFR485.618 No Health Health Care Services Private Sector 1189 2378 0

42CFR485.631 No Health Health Care Services Private Sector 1189 2973 0

42CFR485.635(c)(3) No Health Health Care Services Private Sector 1189 2378 0

42CFR485.641 No Health Health Care Services Private Sector 1189 3567 0

42CFR485.643(a-b) No Health Health Care Services Private Sector 13079 1090 0

42CFR485.645(d) No Health Health Care Services Private Sector 123656 10305 0

42CFR485.635(f) No Health Health Care Services Private Sector 1314 329 0

2011-03-14-04:00

0938-1045 201105-0938-010 0938
             
        "State Plan Template to Implement Section 6062 of the DRA (Opportunity for Families of Disabled Children to Purchase Medicaid Coverage for Such Children) CMS-10232"
             
          
        
The Deficit Reduction Act (DRA) provides States with numerous flexibilities in operating their State Medicaid Programs. Section 6062 of the DRA allows States the opportunity to provide Medicaid benefits to disabled children who would otherwise be ineligible because of family income that is above the State's highest Medicare eligibility standards for children. It specifically allows families with disabled children to "buy-in" to Medicaid, and prevents them from having to stay impoverished, become impoverished, place their children in out-of-home placements, or simply give up custody of their child in order to access needed health care for their disabled children. 2014-07-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 10 60 0

State Plan Template to Implement Section 6062 of the DRA (Opportunity for families of Disabled Children to Purchase Medicaid Coverage for Such Children) CMS-10232 No Health Health Care Services State, Local, and Tribal Governments 10 60 0

2011-07-25-04:00

0938-1046 201107-0938-004 0938
             
        "Certificate of Data Destruction for Data Acquired from the Centers for Medicare and Medicaid Services"
             
          
        
The Privacy Act of 1976, ?552a requires the Centers for Medicare & Medicaid Services (CMS) to track all disclosures of the agency's Personally Identifiable Information (PII) and the exceptions for these data releases. CMS is also required by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the Federal Information Security Management Act (FISMA) of 2002 to properly protect all PII data maintained by the agency. Part of this protection mandates that the data be destroyed when no longer required in a manner that prevents any unauthorized disclosure. When entities request CMS PII data, they enter into a Data Use Agreement (DUA) with CMS. The DUA stipulates that the recipient of CMS PII data must properly protect the data according to FISMA and also provide for its appropriate destruction at the completion of the project/study or the expiration date of the DUA. However, under certain circumstances, the data may be approved in writing by CMS for re-use in an additional or follow-on project/study. The DUA Certificate of Disposition (COD) form provides the data recipient to document accordingly this variance in the disposition of the data or the outright destruction of the data. The "Data Use Agreement (DUA) Certificate of Disposition (COD) for Data Acquired from the Centers for Medicare & Medicaid Services (CMS)" will be used by recipients of CMS data to certify that they have properly disposed of the data that they have received through a CMS DUA. The form requires the submitter to provide the Requestor's organization; DUA number; identification by initials as to the actual disposition of the data; listing of the data descriptions and the years of the data; printed name, phone number and e-mail address of the individual signing the form; signature and date signed; and optional point of contact name, phone number and e-mail address. 2014-09-30-04:00 Active William Parham 4107864669 No No No 500 84 0

Certificate of Data Destruction for Data Acquired from the Centers for Medicare and Medicaid Services No Health Health Care Services
CMS-10252 CMS-10252. Draft Revised DUA Yes No Fillable Fileable Form and instruction CMS-10252. Draft Revised DUA.pdf
Private Sector 500 84 0

2011-09-29-04:00

0938-1047 201105-0938-011 0938
             
        "State Plan Pre-print for Integrated Medicare and Medicaid Programs (CMS-10251)"
             
          
        
Information submitted via the State Plan Amendment(SPA) pre-print will be used by CMS Central and Regional Offices to analyze a State's proposal to implement integrated Medicare and Medicaid programs. The State Plan preprint is an optional document for use by States to highlight the arrangements provided between a State and Medicare Advantage Special Needs Plans that are also providing Medicaid services. State Medicaid Agencies will complete the SPA preprint and submit it to CMS for a comprehensive analysis. The preprint provides the opportunity for States to confirm that their integrated care model complies with both Federal statutory and regulatory requirements. The preprint contains assurances, check-off items, and areas for States to describe policies and procedures for subjects such as enrollment, marketing, and quality assurance. 2014-06-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 10 200 0

State Plan preprint for Integrated Medicare and Medicaid Programs (CMS-10251) No Health Health Care Services
No No Paper Only Instruction Integrated Care Preprint Instructions 1-16-08 revisions.doc CMS-10251 State Plan Preprint for Integrated Care Programs Yes Yes Fillable Fileable Form Integrated Care Preprint 1-16-08 clean copy.doc
State, Local, and Tribal Governments 10 200 0

2011-06-23-04:00

0938-1050 201109-0938-007 0938
             
        "QualityNet Identity Management System (QIMS) Account Form"
             
          
        
The QualityNet Identity Management System (QIMS) account registration form must be completed by any new persons needing access to Consolidated Renal Operations in a Web Enabled Network (CROWNWeb.) The 8,561 existing accounts owners will not have to reregister for new user accounts. The CROWNWeb user community is composed of CMS employees, ESRD Network Organization staff and dialysis facilities staff. The CROWNWeb system is the system used as the collection point of data necessary for entitlement of ESRD patients to Medicare benefits and Federal Government monitoring and assessing of quality and type of care provided to renal patients. The data collected in QIMS will provide the necessary security measures for creating and maintaining active CROWNWeb user accounts and collection of audit trail information required by the CMS Information Security Officers (ISSO). 2014-03-31-04:00 Active William Parham 4107864669 No No No 41039 68520 0

QualityNet Identity Management System (QIMS) Account Form (First Year) No Health Health Care Services
CMS-10267 QIMS- Account Registration Form Yes Yes Fillable Fileable Form and instruction CMS-10267.QIMS-CW_Account Registration_Form 8-8(final).docx
Private Sector 7439 3720 0

QualityNet Identity Management System (QIMS) Account Form (Subsequent Years) No Health Health Care Services
CMS-10267 QIMS- Account Registration Form Yes Yes Fillable Fileable Form and instruction CMS-10267.QIMS-CW_Account Registration_Form 8-8(final).docx
Private Sector 1600 800 0

Training - Annual Security Awareness Power Point Training (first year) No Health Health Care Services
CMS-10267 QIMS- Account Registration Form Yes Yes Fillable Fileable Form and instruction CMS-10267.QIMS-CW_Account Registration_Form 8-8(final).docx
Private Sector 16000 32000 0

Training - Annual Security Awareness Power Point Training (Subsequent Years) No Health Health Care Services
CMS-10267 QIMS- Account Registration Form Yes Yes Fillable Fileable Form and instruction CMS-10267.QIMS-CW_Account Registration_Form 8-8(final).docx
Private Sector 16000 32000 0

2011-10-31-04:00

0938-1052 201308-0938-008 0938
             
        "Consolidated Renal Operations in a Web Enabled Network (CROWNWeb) Third-party Submission Authorization Form"
             
          
        
The sole purpose the CMS-10268 form is to allow Dialysis Facilities to authorize their Corporate Offices to submit data into the CROWNWeb system on their behalf. This five minute effort acutally reduces the Dialysis Facilities burden because they do not have to do monthly data entry on their dialysis patients when they give this authorization to their corporate office. The data is in their corporate system and is electronically entered into CROWNWeb through batch files submissions sent by their corporate office. CMS requires authorization because of the sensitivity of the data. The form is used to document and implement approriate controls on data submission an utilization. 2016-09-30-04:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 400 34 0

Consolidated Renal Operations in a Web Enabled Network (CROWNWeb) Batch Data Submission Form No Health Health Care Services
CMS-10268 Crownweb Batch Data Submission Authorization form Yes Yes Fillable Fileable Form and instruction CROWNWeb Batch Data Submission Authorization Form 25April2013.pdf Yes Yes Fillable Fileable Other CMS-10268 Crosswalk.doc
Private Sector 400 34 0

Consolidated Renal Operations in a Web Enabled Network (CROWNWeb) Third-party Submission Authorization Form (2nd and 3rd Years) No Health Health Care Services
CMS-10268 CMS-10268.CROWNWeb Batch Data Submission Authorization Form Yes No Fillable Fileable Form and instruction CROWNWeb Delegation of Authority Form _0 3_.pdf
Private Sector 0 0 0

2013-09-20-04:00

0938-1053 201112-0938-010 0938
             
        "Administrative Requirements for Section 6071 of the Deficit Reduction Act of 2005 (CMS-10249)"
             
          
        
The Centers for Medicare & Medicaid Services (CMS) awarded 31 grants to States to participate in the Money Follows the Person Rebalancing Demonstration (MFP) from January 1, 2007 through September 30, 2011. This demonstration, created by section 6071 of the Deficit Reduction Act of 2005 (P.L. 109-171), supports State efforts to "rebalance" their long-term support systems by offering $1.75 billion over 5 years in competitive grants to States. Specifically, the demonstration will support State efforts to: a) Rebalance their long-term support system so that individuals have a choice of where they live and receive services; b) Transition individuals from institutions who want to live in the community; and c) Promote a strategic approach to implement a system that provides person centered, appropriate, needs based, quality of care and quality of life services and a quality management strategy that ensures the provision of, and improvement of such services in both home and community-based settings and institutions. The demonstration provides enhanced federal medical assistance percentage (FMAP) for 12 months for qualified home and community-based services for each person transitioned from an institution to the community during the demonstration period. 2015-06-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 106269 39058 0

Administrative Requirements for Section 6071 of the DRA (CMS-10249) No Health Health Care Services
Yes No Fillable Printable Instruction MFP_QoL_Final_version_English.pdf Yes No Fillable Printable Instruction File_Layout_for_MFP_Program_Participation_Data_File.pdf Yes No Fillable Printable Instruction File_Layout_for_MFP_Services_File.pdf CMS-10249 Semi-Annual Progress Report Yes Yes Fillable Printable Form and instruction 2011_1st_Period_Test_Progress_Rpt.pdf CMS-10249 MFP Grant Program Yes Yes Fillable Fileable Form 2011-10-12 MFP 2011 1st Period Screen Shots.pdf Yes No Fillable Printable Instruction File_Layout_for_MFP_Finders_File.pdf
State, Local, and Tribal Governments 106269 39058 0

2012-06-12-04:00

0938-1054 201105-0938-008 0938
             
        "Part C Medicare Advantage Reporting Requirements and Supporting Regulations in 42 CFR 422.516 (a)"
             
          
        
The collection forces MA organizations to develop, compile, evaluate, and report to CMS, to its enrollees, and to the general public, as required by CMS' regulatory authority, which establishes reporting requirements (to ensure effective monitoring) for Part C Medicare Advantage. 2014-12-31-05:00 Active William Parham 4107864669 No No No 8445 208920 0

Part C Medicare Advantage Reporting Requirements and Supporting Regulations in 42 CFR 422.516 (a) - (CMS-10261) No Health Health Care Services
CMS-10261 Attachment I - Part C Reporting Overview Yes Yes Paper Only Form Attachment I.9.23.08.doc CMS-10261 Medicare Part C Reporting Requirements Yes Yes Paper Only Form and instruction Attachment II Part C Reporting Overview 9 25 08.doc CMS-10261 Attachment III - Medicare Advantage Medical Utilization and Expenditure Experience No No Paper Only Form Attachment III-9-22-08.xls
Private Sector 8445 208920 0

2011-12-20-05:00

0938-1056 201210-0938-010 0938
             
        "Medicare Enrollment Application (Form 855S)"
             
          
        
The primary function of the CMS 855S DMEPOS supplier enrollment application is to gather information from a supplier that tells us who it is, whether it meets certain qualifications to be a health care supplier, where it renders its services or supplies, the identity of the owners of the enrolling entity, and information necessary to establish the correct claims payment. The goal of evaluating and revising the CMS 855S DMEPOS supplier enrollment application is to simplify and clarify the information collection without jeopardizing our need to collect specific information. Additionally, periodically new congressional legislation requires CMS to update the Medicare Provider Enrollment Applications (CMS 855s). Recently approved/passed legislation requires CMS to make slight revisions to the CMS 855S application. The majority of these changes are very minor in nature such as a question with a "Yes/No" check box, spelling and formatting corrections, removal of duplicate fields, instruction clarification for the DMEPOS supplier and indicating services rendered from check lists. 2015-12-31-05:00 Active William Parham 4107864669 No No No 43350 113550 0

Initial Enrollment No Health Health Care Services
CMS-855-S Medicare Enrollment Application: Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Suppliers Yes No Fillable Fileable Form and instruction 855 PECOS Screen Shots for OSORA.docx CMS-855S Medicare Durable Medical Equipment Supplier Enrollment Application Yes No Fillable Fileable Form and instruction CMS-855S.pdf
Private Sector 8750 35000 0

Change of Enrollment Information No Health Health Care Services
CMS-855-S Medicare Enrollment Application: Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Suppliers Yes No Fillable Fileable Form and instruction 855 PECOS Screen Shots for OSORA.docx CMS-855S Medicare Durable Medical Equipment Supplier Enrollment Application Yes No Fillable Fileable Form and instruction CMS-855S.pdf CMS-855(S) Medicare Durable Medical Equipment Supplier Enrollment Application Yes No Fillable Fileable Form and instruction CMS-855S(6-30-11).pdf
Private Sector 17100 8550 0

Revalidation of enrollment information No Health Health Care Services
CMS-855-S Medicare Enrollment Application: Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Suppliers Yes No Fillable Fileable Form and instruction 855 PECOS Screen Shots for OSORA.docx CMS-855S Medicare Durable Medical Equipment Supplier Enrollment Application Yes No Fillable Fileable Form and instruction CMS-855S.pdf
Private Sector 17500 70000 0

Surety Bond Compliance No Health Health Care Services
CMS-855(S) Medicare Durable Medical Equipment Supplier Enrollment Application Yes No Fillable Fileable Form and instruction CMS-855S(6-30-11).pdf
Private Sector 0 0 0

2012-12-20-05:00

0938-1059 201309-0938-018 0938
             
        "Physician Quality Reporting System (PQRS)"
             
          
        
In accordance with section 1848(k)(2) of the Social Security Act (the Act), an eligible professional who satisfactorily submits data on quality measures for covered professional services furnished in 2010 and 2011 as part of the PQRI can qualify to receive an incentive payment equal to 2.0% and 1.0%, respectively, of the eligible professional's total estimated Medicare Part B PFS allowed charges. In addition, section 1848(m)(5)(F) of the Act requires us to establish alternative criteria for satisfactorily reporting PQRI quality measures data through medical registries. In addition to reporting data on PQRI quality measures on their Medicare Part B claims, eligible professionals may authorize or instruct the registry to submit quality measures results and numerator and denominator data on quality measures to CMS on their behalf or extract clinical quality data from a qualified EHR and submit the data to a CMS-designated clinical quality data warehouse. To be qualified to submit PQRI quality measures results and numerator data on quality measures on behalf of eligible professionals, a registry will need to self-nominate to become a "qualified" PQRI registry unless the registry was qualified for a prior year and successfully submits PQRI quality measure results and numerator and denominator data on quality measures on behalf of their participants for such year. To be qualified for the purpose of an eligible professional submitting data on PQRI quality measures, an EHR vendor was required to self-nominate to have one or more of its EHR products designated a "qualified" PQRI EHR product. 2015-01-31-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 11600250 4006121 0

PQRS Registry No Health Health Care Services Private Sector 50 500 0

PQRS EHR No Health Health Care Services Private Sector 0 0 0

PQRS - GPRO No Health Health Care Services Private Sector 200 17000 0

PQRS - Individual EP No Health Health Care Services Private Sector 11600000 3988621 0

2014-01-15-05:00

0938-1065 201111-0938-006 0938
             
        "CHIPRA 2009, Dental Provider and Benefit Information Posted on Insure Kids Now!  Website (CMS-10291)"
             
          
        
This is necessary to collect information on State Medicaid and CHIP dental benefits. 2014-12-31-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 255 9690 0

Collection of Dental Provider Information No Health Health Care Services
CMS-10291 Insure Kids Now (Provider Data Submission Technical Information) Yes Yes Printable Only Form and instruction InsureKidsNow-Technical-Document 201102 FINAL.docx Yes Yes Printable Only Other Provider Info - Disclosure Statement.doc
State, Local, and Tribal Governments 204 8160 0

Collection of Dental Benefit Information No Health Health Care Services
CMS-10291 Description of Dental Benefits Provided Under Medicaid and the Children's Health Insurance Program (CHIP) Yes Yes Fillable Printable Form Dental Benefits - Description [rev 11-22-11].doc CMS-10291 Children's Dental Benefits Survey Yes Yes Fillable Printable Form Copy of Dental Benefits - Survey --- rev 11-22-11.xlsx
State, Local, and Tribal Governments 51 1530 0

2011-12-20-05:00

0938-1066 201011-0938-018 0938
             
        "CAHPS Home Health Care Survey"
             
          
        
As part of the DHHS Transparency Initiative on Quality Reporting, CMS plans to implement a process to measure and publicly report patients' experiences with home health care they receive from Medicare-certified home health agencies through the data collection effort described in this request: the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Home Health Care Survey. The Home Health Care CAHPS Survey, which was developed and tested by the Agency for Healthcare Research and Quality (AHRQ) and is part of the family of CAHPS surveys, is a standardized survey for home health patients to assess their home health care providers and the quality of the home health care they receive. Prior to the Home Health Care CAHPS survey, there was no national standard for collecting data about home health care patients' experience with their home health care. This is a revision to the original PRA package which covered the voluntary implementation of the survey among Medicare-certified agencies and a randomized mode experiment to test the impact of different modes of data collection on survey responses. This is a revised PRA package because it now includes the burden to the home health agencies (HHAs) to contract with an approved HHCAHPS survey vendor to administer the HHCAHPS survey on their behalf. 2014-03-31-04:00 Active Bonnie Harkless 4107865666 No No No 2715890 699440 39560000

CAHPS Home Health Care Survey (CMS-10275) No Health Health Care Services Individuals or Households 2706000 541200 0

CAHPS Home Health Care Survey No Health Health Care Services Private Sector 9890 158240 39560000

2011-03-14-04:00

0938-1073 201306-0938-010 0938
             
        "Recovery Act - Reporting Requirements for States Under FMAP Increase and TMA Provisions (CMS-10295)"
             
          
        
The American Recovery and Reinvestment Act of 2009 (Recovery Act), Public Law 111-5, requires that States submit quarterly reports to the Secretary of Health and Human Services in accordance with section 5001 Temporary Increase of Medicaid Federal Medical Assistance Percentage (FMAP) and section 5004(d) Extension of Transitional Medical Assistance (TMA). The reports under section 5001 are required for the period of October 1, 2008 - September 30, 2011. The reports under section 5004 are required beginning on July 1, 2009 until the Federal authority for TMA coverage sunsets (now scheduled to sunset on December 31, 2010). Each State Medicaid agency will submit its quarterly reports to the appropriate Regional Office of the Centers for Medicare & Medicaid Services. The reports will be compiled and summarized for annual reports to Congress. 2016-07-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 Yes No No 200 400 0

Recovery Act - Reporting Requirements for States Under FMAP Increase and TMA Provisions (CMS-10295) No Health Health Care Services
CMS-10295 State Report on the Transitional Medical Assistance Yes Yes Fillable Printable Form and instruction ARRA-Sec-5004-State-Report-3.xlsx
State, Local, and Tribal Governments 200 400 0

2013-07-02-04:00

0938-1077 201308-0938-001 0938
             
        "Notice of Research Exception under the Genetic Information Nondiscrimination Act"
             
          
        
Under the Genetic Information Nondiscrimination Act of 2008 (GINA), a plan or issuer may request (but not require) a genetic test in connection with certain research activities so long as such activities comply with specific requirements, including: (i) the research complies with 45 CFR part 46 or equivalent federal regulations and applicable State or local law or regulations for the protection of human subjects in research;, (ii) the request for the participant or beneficiary (or in the case of a minor child, the legal guardian of such beneficiary) is made in writing and clearly indicates that compliance with the request is voluntary and that non-compliance will have no effect on eligibility for benefits or premium or contribution amounts; and (iii) no genetic information collected or acquired will be used for underwriting purposes. The Secretary of Labor or the Secretary of Health and Human Services is required to be notified if a group health plan or health insurance issuer intends to claim the research exception permitted under Title I of GINA. Nonfederal governmental group health plans and issuers solely in the individual health insurance market or Medigap market will be required to file with the Centers for Medicare & Medicaid Services (CMS). The Notice of Research Exception under the Genetic Information Nondiscrimination Act is a model notice that can be completed by group health plans and health insurance issuers and filed with either the Department of Labor or CMS to comply with the notification requirement. 2016-09-30-04:00 Active Jamaa Hill 301 492-4190 No Yes No 2 1 0

Notice of Research Exception under the Genetic Information Nondiscrimination Act (GINA) No Health Health Care Services
CMS-10286 GINA Research Execption Notice Yes Yes Paper Only Form and instruction CMS-10286 GINA_Research_Exception_Notice.pdf
Private Sector 2 1 0

2013-09-20-04:00

0938-1078 201306-0938-002 0938
             
        "Collection Requirements for Compendia for Determination of Medically-Accepted Indications for Off-label Uses of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen"
             
          
        
All currently listed compendia will be required to comply with these provisions, as of January 1, 2010, to remain on the list of recognized compendia. In addition, any compendium that is the subject of a future request for inclusion on the list of recognized compendia will be required to comply with these provisions. No compendium can be on the list if it does not fully meet the standard described in section 1861(t)(2)(B) of the Act, as revised by section 182(b) of the MIPPA. 2016-07-31-04:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 900 5135 0

Internal or external request for listing of therapy recommendation including criteria used to evaluate the response No Health Health Care Services Private Sector 100 100 0

A listing of all evidentiary materials reviewed or considered by compendia pursuant to a response No Health Health Care Services Private Sector 100 100 0

A listing of all respondents No Health Health Care Services Private Sector 100 845 0

Minutes and voting records of meetings for the review and disposition of the response No Health Health Care Services Private Sector 400 2400 0

Direct or indirect financial relationships between respondents and the manufacturer or seller of the drug or biological being reviewed by compendia No Health Health Care Services Private Sector 100 845 0

Ownership or investment relationships between respondents and the manufacturer or seller of the drug or biological being reviewed by compendia No Health Health Care Services Private Sector 100 845 0

2013-07-26-04:00

0938-1079 201306-0938-004 0938
             
        "Grandfathering Provisions of the Medicare DMEPOS Competitive Bidding Program"
             
          
        
We established the grandfathering process in the April 10, 2007 final rule for competitive bidding (72 FR 17992) for rented DME and oxygen and oxygen equipment when these items are included under the Medicare DMEPOS Competitive Bidding Program. This process only applies to suppliers that rented DME and oxygen and oxygen equipment to beneficiaries who maintain a permanent residence in a CBA before the implementation of the competitive bidding program. We established beneficiary notification requirements for noncontract suppliers that are furnishing rented oxygen or DME competitive bid items at the time a competitive bidding program is implemented in a competitive bidding area (74 FR 61738). This notification will ensure that beneficiaries are sufficiently informed and prepared for competitive bidding changes that affect rented DME and oxygen. 2016-08-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 654464 79799 0

Suppliers that Choose Not to Grandfather (10 and 2-day Notifications to Beneficiaries) No Health Health Care Services Private Sector 0 0 0

Suppliers that Choose Not to Grandfather (Development of 30-day Notifications to Beneficiaries) No Health Health Care Services Private Sector 0 0 0

Suppliers that Choose Not to Grandfather (30-day Notifications to Beneficiaries) No Health Health Care Services Private Sector 0 0 0

Suppliers that Choose to Grandfather (Development and Submission of 30-day Notification to CMS) No Health Health Care Services Private Sector 0 0 0

Suppliers that Choose to Grandfather (Development of 30-day Notification to Beneficiaries) No Health Health Care Services Private Sector 0 0 0

Suppliers that Choose to Grandfather (Submission of 30-day Notification to Beneficiaries) No Health Health Care Services Private Sector 0 0 0

Suppliers that Choose to Grandfather - Round 1 Recompete (30-Day Notification to Beneficiary) No Health Health Care Services Private Sector 14835 1318 0

Suppliers that Choose to Grandfather - Round 2 (30-Day Notification to Beneficiary) No Health Health Care Services Private Sector 520667 43736 0

Suppliers that Choose Not to Grandfather - Round 1 Recompete (30-Day Notification to Beneficiary) No Health Health Care Services Private Sector 1648 146 0

Suppliers that Choose Not to Grandfather - Round 1 Recompete (10-Day and 2-Day Notifications) No Health Health Care Services Private Sector 1648 824 0

Suppliers that Choose Not to Grandfather - Round 2 (30-Day Notification to Beneficiary) No Health Health Care Services Private Sector 57833 4858 0

Suppliers that Choose Not to Grandfather - Round 2 (10-Day and 2-Day Notifications) No Health Health Care Services Private Sector 57833 28917 0

2013-08-12-04:00

0938-1083 201312-0938-020 0938
             
        "Medicare Program/Home Health Prospective Payment System Rate Update for CY2010: Physician Narrative Requirement, CY2011 Final Physician Face-to-Face Encounter"
             
          
        
The Centers for Medicare and Medicaid Services (CMS) require that a physician sign every patient's individual plan of care certifying or recertifying that the patient is homebound and the planned services are medically necessary in order for the home health agency to be reimbursed for Medicare covered services as stipulated in 42 CFR 424.22. CMS is relying on physicians to fulfill a role that is sometimes thought of as a "gatekeeper" by requiring the physician to provide a narrative located within the home health certification or recertification when skilled nursing management & evaluation of the plan of care, (PoC) is ordered. The physician's narrative is required when a patient's underlying condition or complication requires a registered nurse to ensure that essential non-skilled care is achieving its purpose, The narrative must be located immediately prior to the physician's signature. If the narrative exists as an addendum to the certification or recertification form, in addition to the physician's signature on the certification or recertification form, the physician must sign immediately following the narrative in the addendum. This change supports Medicare's home health coverage criteria for skilled services as stipulated in the CFR, (see 42 CFR 409.42).The Home Health Prospective Payment System Rate Update for Calendar Year 2011 changes the certification requirements for Home Health Agencies. In the case of a certification made by a physician after January 1, 2010, prior to making such certification, the physician must document that the physician himself or herself or specified non-physician practitioner has had a face-to-face encounter with the patient incident to the services involved 2017-02-28-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 3281452 277384 0

Physician's Burden for Form Completion, Supporting Regulation 424.22 No Health Health Care Services Private Sector 345600 28800 0

Face-to-Face encounter, form development (424.22 first year) No Health Health Care Services Private Sector 9432 4716 0

Face-to-Face encounter, physician's burden for form completion, supporting regulation 424.22 (annual) No Health Health Care Services Private Sector 2926420 243868 0

2014-02-06-05:00

0938-1085 201103-0938-017 0938
             
        "Temporary High Risk Pool Program (CMS-10319)"
             
          
        
The revised data collection will include requirements outlined in both the regulation and the application to submit the following: o The application for a state or its designated entity to request participation in the temporary high risk pool program; o Contract acceptance for those states or its designated entity who submit an acceptable application to HHS; o Payment invoices; o Reporting requirements; o Dumping reporting requirements; and o Audit requirements. This above information will assist HHS in planning for and executing contracts with States to provide a high risk pool program. 2014-05-31-04:00 Active William Parham 4107864669 No Yes No 4 1376 0

Letter of Intent and Submission of Contact Information No Health Health Care Services
CMS-10319 Appendix A Yes Yes Fillable Fileable Signable Form and instruction High Risk Pools.pdf
State, Local, and Tribal Governments 2 8 0

Submission of Contact Information No Health Health Care Services
CMS-10319 Appendix A Yes Yes Fillable Fileable Signable Form and instruction High Risk Pools.pdf
State, Local, and Tribal Governments 0 0 0

Solicitation and Contractor's Proposal Process No Health Health Care Services
CMS-10319 CMS-10319.Full Solicitation for State Proposals Yes Yes Fillable Fileable Signable Form and instruction CMS-10319.Full Solicitation for State Proposals with PRA Disclosure 5-5-2010--HHS .docx
State, Local, and Tribal Governments 2 1368 0

2011-05-31-04:00

0938-1086 201212-0938-005 0938
             
        "Health Care Reform Insurance Web Portal and Supporting Authority Contained in Sections 1103 and 10102 of The Patient Protection and Affordability Care Act, P.L. 111-148 (PPACA)"
             
          
        
In accordance with Sections 1103 and 10102 of The Patient Protection and Affordability Care Act, P.L. 111-148 (PPACA) the U.S. Department of Health and Human Services (DHHS) is tasked with developing and implementing an Internet website portal to assist consumers with identifying affordable and comprehensive health insurance coverage options that are available in their State. CCIIO has created a system where insurance issuers and their states log into the web portal using a custom user ID and password validation. The states were asked to provide information on issuers in their state and various websites (see Appendix E). The issuers have been downloading a basic information template to enter data then upload into the portal. Information to be collected on issuers and products can be found in Appendix C. The pricing and benefits data that will be collected can be found in Appendix D. The templates and instructions presented in support of this PRA package as Appendix G are those developed for the prior data collections. 2016-03-31-04:00 Active William Parham 4107864669 No Yes No 5550 91225 0

States - Data submission No Health Health Care Services
CMS-10320 CMS-10320 Appendix_E_StateRequirements Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_E_StateRequirements.pdf CMS-10320 CMS-10320.FINAL State Instructions and Instrument (5-5-10). Yes No Fillable Fileable Signable Form and instruction CMS-10320.FINAL State Instructions and Instrument (5-5-10).pdf
State, Local, and Tribal Governments 50 25 0

States - Training, reviewing regulation, and analyzing data No Health Health Care Services
CMS-10320 CMS-10320.FINAL State Instructions and Instrument (5-5-10). Yes Yes Fillable Fileable Signable Form and instruction CMS-10320.FINAL State Instructions and Instrument (5-5-10).pdf CMS-10320 CMS-10320 Appendix_E_StateRequirements Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_E_StateRequirements.pdf
State, Local, and Tribal Governments 50 100 0

States - Data Collection No Health Health Care Services
CMS-10320 CMS-10320 Appendix_E_StateRequirements Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_E_StateRequirements.pdf CMS-10320 CMS-10320.FINAL State Instructions and Instrument Yes Yes Fillable Fileable Form and instruction CMS-10320.FINAL State Instructions and Instrument (5-5-10)[1].pdf
State, Local, and Tribal Governments 50 400 0

Issuers Training and Communication No Health Health Care Services
CMS-10320 CMS-10320.Issuer - FINAL Instructions and Instruments Yes Yes Fillable Fileable Form and instruction CMS-10320.Issuer - FINAL Instructions and Instruments (5-12-10).pdf CMS-10320 CMS-10320 Appendix_C_InsuranceIssuers Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_C_InsuranceIssuers.pdf CMS-10320 CMS-10320 Appendix_D_BenefitsPremiumsInformation No No Fillable Fileable Form and instruction CMS-10320 Appendix_D_BenefitsPremiumsInformation20120801.pdf
Private Sector 800 24000 0

Issuers - Submission Preparation (Individual) No Health Health Care Services
CMS-10320 CMS-10320 Appendix_C_InsuranceIssuers Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_C_InsuranceIssuers.pdf CMS-10320 CMS-10320.Issuer - FINAL Instructions and Instruments Yes Yes Fillable Fileable Form and instruction CMS-10320.Issuer - FINAL Instructions and Instruments (5-12-10).pdf CMS-10320 CMS-10320 Appendix_D_BenefitsPremiumsInformation Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_D_BenefitsPremiumsInformation20120801.pdf
Private Sector 450 19800 0

Issuers - Submission Preparation (Small Group) No Health Health Care Services
CMS-10320 CMS-10320.Issuer - FINAL Instructions and Instruments Yes Yes Fillable Fileable Form and instruction CMS-10320.Issuer - FINAL Instructions and Instruments (5-12-10).pdf CMS-10320 CMS-10320 Appendix_D_BenefitsPremiumsInformation Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_D_BenefitsPremiumsInformation20120801.pdf CMS-10320 CMS-10320 Appendix_C_InsuranceIssuers Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_C_InsuranceIssuers.pdf
Private Sector 700 30800 0

Issuer - Data Entry (Individual) No Health Health Care Services
CMS-10320 CMS-10320.Issuer - FINAL Instructions and Instruments Yes Yes Fillable Fileable Form and instruction CMS-10320.Issuer - FINAL Instructions and Instruments (5-12-10).pdf CMS-10320 CMS-10320 Appendix_D_BenefitsPremiumsInformation20120801 Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_D_BenefitsPremiumsInformation20120801.pdf CMS-10320 CMS-10320 Appendix_C_InsuranceIssuers Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_C_InsuranceIssuers.pdf
Private Sector 450 1800 0

Issuer - Data Entry (Small Group) No Health Health Care Services
CMS-10320 CMS-10320 Appendix_C_InsuranceIssuers Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_C_InsuranceIssuers.pdf CMS-10320 CMS-10320 Appendix_D_BenefitsPremiumsInformation Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_D_BenefitsPremiumsInformation20120801.pdf CMS-10320 CMS-10320.Issuer - FINAL Instructions and Instruments Yes Yes Fillable Fileable Form and instruction CMS-10320.Issuer - FINAL Instructions and Instruments (5-12-10).pdf
Private Sector 700 2800 0

Issuer - Troubleshoot (Individual) No Health Health Care Services
CMS-10320 CMS-10320 Appendix_C_InsuranceIssuers Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_C_InsuranceIssuers.pdf CMS-10320 CMS-10320 Appendix_D_BenefitsPremiumsInformation Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_D_BenefitsPremiumsInformation20120801.pdf CMS-10320 CMS-10320.Issuer - FINAL Instructions and Instruments Yes Yes Fillable Fileable Form and instruction CMS-10320.Issuer - FINAL Instructions and Instruments (5-12-10).pdf
Private Sector 450 3600 0

Issuer - Troubleshoot (Small Group) No Health Health Care Services
CMS-10320 CMS-10320.Issuer - FINAL Instructions and Instruments Yes Yes Fillable Fileable Form and instruction CMS-10320.Issuer - FINAL Instructions and Instruments (5-12-10).pdf CMS-10320 CMS-10320 Appendix_C_InsuranceIssuers Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_C_InsuranceIssuers.pdf CMS-10320 CMS-10320 Appendix_D_BenefitsPremiumsInformation Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_D_BenefitsPremiumsInformation20120801.pdf
Private Sector 700 5600 0

Issuer - Attest (Individual) No Health Health Care Services
CMS-10320 CMS-10320 Appendix_D_BenefitsPremiumsInformation Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_D_BenefitsPremiumsInformation20120801.pdf CMS-10320 CMS-10320.Issuer - FINAL Instructions and Instruments Yes Yes Fillable Fileable Form and instruction CMS-10320.Issuer - FINAL Instructions and Instruments (5-12-10).pdf CMS-10320 CMS-10320 Appendix_C_InsuranceIssuers Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_C_InsuranceIssuers.pdf
Private Sector 450 900 0

Issuer - Attest (Small Group) No Health Health Care Services
CMS-10320 CMS-10320.Issuer - FINAL Instructions and Instruments Yes Yes Fillable Fileable Form and instruction CMS-10320.Issuer - FINAL Instructions and Instruments (5-12-10).pdf CMS-10320 CMS-10320 Appendix_C_InsuranceIssuers Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_C_InsuranceIssuers.pdf CMS-10320 10350\10320\Files for 30-day 8-7-12\CMS-10320 Appendix_D_BenefitsPremiumsInformation Yes Yes Fillable Fileable Form and instruction CMS-10320 Appendix_D_BenefitsPremiumsInformation20120801.pdf
Private Sector 700 1400 0

2013-03-20-04:00

0938-1087 201202-0938-004 0938
             
        "Early Retiree Reinsurance Program"
             
          
        
This information collection request covers the recordkeeping and reporting requirements associated with the Early Retiree Reinsurance Program. 2014-09-30-04:00 Active William Parham 4107864669 No Yes No 14086 283211 0

Public Written Agreement Year 2_3_4 No Health Health Care Services
Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx
State, Local, and Tribal Governments 0 0 0

Private Written Agreement Year 2_3_4 No Health Health Care Services
Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx
Private Sector 0 0 0

Private Fraud and Abuse Procedures Years 2_3_4 No Health Health Care Services
CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx
Private Sector 0 0 0

Public Fraud and Abuse Procedures Years 2_3_4 No Health Health Care Services
Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx
State, Local, and Tribal Governments 0 0 0

Public Maintenance of Records Year 2_3_4 No Health Health Care Services
Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx
State, Local, and Tribal Governments 0 0 0

Private Maintenance of Records Year 2_3_4 No Health Health Care Services Private Sector 0 0 0

Public Data Inaccuracies Years 2_3_4 No Health Health Care Services
Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx
State, Local, and Tribal Governments 0 0 0

Public CHOW Years 2_3_4 No Health Health Care Services
CMS-10321 ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx
State, Local, and Tribal Governments 0 0 0

Private CHOW Years 2_3_4 No Health Health Care Services
CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx
State, Local, and Tribal Governments 0 0 0

Private Data Inaccuracies Years 2_3_4 No Health Health Care Services
Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx CMS-10321 ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx
Private Sector 0 0 0

Public Application Update Year 2_3_4 No Health Health Care Services
CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx
State, Local, and Tribal Governments 0 0 0

Private Application Update Year 2_3_4 No Health Health Care Services
CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx
Private Sector 0 0 0

Early Retiree Reinsurance Program Appeals (Private), for Program Years 2 and 3 No Health Health Care Services
Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx
Private Sector 0 0 0

Early Retiree Reinsurance Program Rerimburement Request Materials and Instructions (Cost Documentation) (Private) Program Year 2 No Health Health Care Services
Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx
Private Sector 0 0 0

Early Retiree Reinsurance Program Rerimburement Request Materials and Instructions (Cost Documentation) (Private) Program Year 3 No Health Health Care Services
CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx
Private Sector 0 0 0

Early Retiree Reinsurance Program Rerimburement Request Materials and Instructions (Cost Documentation) (Private) Program Year 4 No Health Health Care Services
Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx
Private Sector 0 0 0

Early Retiree Reinsurance Program Rerimburement Request Materials and Instructions (Cost Documentation) (Public) Program Year 2 No Health Health Care Services
Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx
State, Local, and Tribal Governments 0 0 0

Early Retiree Reinsurance Program Rerimburement Request Materials and Instructions (Cost Documentation) (Public) Program Year 3 No Health Health Care Services
Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx
State, Local, and Tribal Governments 0 0 0

Early Retiree Reinsurance Program Appeals (Private), for Program Year 4 No Health Health Care Services
CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx
Private Sector 0 0 0

Early Retiree Reinsurance Program Rerimburement Request Materials and Instructions (Cost Documentation) (Public) Program Year 4 No Health Health Care Services
CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx
State, Local, and Tribal Governments 0 0 0

Early Retiree Reinsurance Program Appeals (Public), for Program Years 2 and 3 No Health Health Care Services
Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx
State, Local, and Tribal Governments 0 0 0

Early Retiree Reinsurance Program Reopening Requests (Private), for Program Years 2, 3, 4 No Health Health Care Services
CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx
Private Sector 0 0 0

Early Retiree Reinsurance Program Appeals (Public), for Program Year 4 No Health Health Care Services
Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx
State, Local, and Tribal Governments 0 0 0

Early Retiree Reinsurance Program Reopening Requests (Pub lic), for Program Years 2, 3, 4 No Health Health Care Services
Yes No Fillable Fileable Instruction 0938-1087 Revised_Instrument Collection Instructions.docx CMS-10321 Revised ERRP Collection Instrument Yes No Fillable Fileable Form 0938-1087 Revised ERRP Collection Instrument-1.docx
State, Local, and Tribal Governments 0 0 0

(149.35(b)(2)) - Written Agreement with Issuer or Plan No Health Health Care Services Private Sector 1528 1528 0

(149.35(b)(3)) - Procedures to Protect Against Fraud, etc. No Health Health Care Services Private Sector 1528 30560 0

(149.40) - Updating Data in the Application No Health Health Care Services
Yes No Printable Only Instruction CMS-10321.ERRP Application Instructions (508).pdf CMS-10321 ERRP Application Yes No Fillable Printable Form CMS-10321.ERRP Application (508).pdf
Private Sector 916 916 0

(149.335) - Documentation of Actual Medical Claims Involved No Health Health Care Services
Yes No Fillable Fileable Instruction ERRP Prima Facie Evidence Cover Sheet Instructions.pdf CMS-10321 ERRP Prima Facie Evidence Cover Sheet Yes Yes Fillable Fileable Form ERRP Prima Facie Evidence Cover Sheet.pdf
Private Sector 2371 208683 0

(149.350) Maintenance of Records No Health Health Care Services Private Sector 7500 36660 0

(149.500 & 149.510) - Requesting Appeals No Health Health Care Services Private Sector 143 1144 0

(149.600) - Reporting Previous Data Inaccuracies No Health Health Care Services Private Sector 40 3520 0

(149.610) - Requesting Reopenings No Health Health Care Services Private Sector 20 160 0

(149.700) - Reporting Change of Ownership No Health Health Care Services Private Sector 40 40 0

2012-03-23-04:00

0938-1088 201108-0938-002 0938
             
        "State Medicaid HIT Plan (SMHP) and Template for Implementation of Section 4201 of ARRA (CMS-10292)"
             
          
        
This information collection is being requested in order that States can submit documentation to CMS for review and approval in order that States can implement the Medicaid program and draw down Federal financial participation. The American Reinvestment and Recovery Act of 2009 provides States with the flexibility to request funds to develop a health information technology vision and road to get to the ultimate goal of meaningful use of certified EHR technology. We will be sending State Medicaid Directors letters and templates for the SMHP, the PAPD and IAPD to States in an effort to request these changes, if they so choose and to make the process as simple as possible. These documents will be collections of data and therefore, the need for this information request. 2014-10-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 Yes No No 56 896 0

State Medicaid HIT Plan (SMHP) and Template for Implementation of Section 4201 of ARRA (CMS-10292) No Health Health Care Services
CMS-10292 (SMHP) State Medicaid HIT Plan (SMHP) Yes Yes Fillable Fileable Form and instruction STATE_MEDICAID_HIT_PLAN_Update_09152010 Rev.doc CMS-10292 (HIT P-APD) Model Checklist: HIT Planning-Advance Planning Document (HIT P-APD) Yes Yes Fillable Fileable Form and instruction Model HIT P-APD Update 9 15 10 Rev.doc CMS-10292 (IAPD) Implementation Advanced Planning Document (IAPD) Template Yes Yes Printable Only Form and instruction Medicaid_HIT_IAPD_Template_06_20_2011.docx
State, Local, and Tribal Governments 56 896 0

2011-10-23-04:00

0938-1091 201311-0938-030 0938
             
        "Comprehensive Outpatient Rehabilitation Facilites (CORFs) Conditions of Participation (CoP) and Supporting Regulations"
             
          
        
This information collection package is a request for reinstatement of information collection requirements. With this submission, we have updated the current number of CORFs and wages/salary figures. The current OMB collection 0938-0267 (2 forms) is being combined with this information collection package to move forward as one collection in the future. The information collection requirements, as discussed in the supporting statement are needed to implement the Medicare and Medicaid Conditions of Participation for 274 CORFs. 2017-02-28-05:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 628 8076 0

42 CFR 485.54(a) and (b) No Health Health Care Services Private Sector 0 0 0

42 CFR 485.56(b) No Health Health Care Services Private Sector 0 0 0

42 CFR 485.56(c) No Health Health Care Services Private Sector 0 0 0

42 CFR 485.56(d) No Health Health Care Services Private Sector 0 0 0

42 CFR 485.56(e) No Health Health Care Services Private Sector 0 0 0

42 CFR 485.58(c) No Health Health Care Services Private Sector 0 0 0

42 CFR 485.64(a)(1),(2),(3), (4), (b)(1) and (2) Disaster procedures No Health Health Care Services Private Sector 274 4384 0

42 CFR 485.64(b)(1) No Health Health Care Services Private Sector 0 0 0

42 CFR 485.64(b)(2) No Health Health Care Services Private Sector 0 0 0

42 CFR 485.66(b)(1), (2), and 3(i),(ii) Untilization review plan No Health Health Care Services Private Sector 274 3562 0

CORF Request for Certification Form - CMS-359 No Health Health Care Services
CMS-10282 CORF Request for Certification to Participate in the Medicare Program No No Fillable Fileable Form and instruction CMS-359.pdf
Private Sector 40 10 0

CORF Survey Report - Form 360 No Health Health Care Services
CMS-10282 CORF Survey Report No No Fillable Fileable Form and instruction CMS-360.pdf
Private Sector 40 120 0

2014-02-12-05:00

0938-1093 201307-0938-010 0938
             
        "Disclosure and Recordkeeping Requirements for Grandfathered Health Plans under the Affordable Care Act"
             
          
        
Section 1251 of the ACA provides that certain plans and health insurance coverage in existence as of March 23, 2010, known as grandfathered health plans, are not required to comply with certain statutory provisions in the Act.To maintain its status as a grandfathered health plan, the interim final rule (75 FR 34538, June 17, 2010) require the plan to maintain records documenting the terms of the plan in effect on March 23, 2010, and any other documents that are necessary to verify, explain or clarify status as a grandfathered health plan.The plan must make such records available for examination upon request by participants,beneficiaries, individual policy subscribers, or a State or Federal agency official. A grandfathered health plan is also required to include a statement in any plan material provided to participants or beneficiaries describing the benefits provided under the plan or health insurance coverage, the plan or coverage believes it is a grandfathered health plan within the meaning of section 1251 of the ACA, that being a grandfathered health plan means that the plan does not include certain consumer protections of the ACA, and providing contact information for participants to direct questions regarding which protections apply and which protections do not apply to a grandfathered health plan and what might cause a plan to change from grandfathered health plan status and to file complaints. The amendment to the interim final rule (75 FR 70114, November 17, 2010) requires a grandfathered group health plan that is changing health insurance issuers to provide the succeeding health insurance issuer (and the succeeding health insurance issuer must require) documentation of plan terms (including benefits, cost sharing, employer contributions, and annual limits) under the prior health insurance coverage sufficient to make a determination whether the standards of paragraph (g)(1) of the interim final regulations are exceeded. 2016-09-30-04:00 Active William Parham 4107864669 No Yes No 2573 86 2573

Disclosure and Recordkeeping Requirements No Health Health Care Services Private Sector 10 1 10

Grandfathered Plan Change in Carrier Disclosure No Health Health Care Services State, Local, and Tribal Governments 2563 85 2563

2013-09-26-04:00

0938-1094 201307-0938-014 0938
             
        "Enrollment Opportunity Notice Relating to Lifetime Limits; Required Notice of Rescission of Coverage; and Disclosure Requirements for Patient Protection under the Affordable Care Act (P.L. 111-148) "
             
          
        
Provisions 2711, 2712 and 2719A of the Affordable Care Act contain enrollment opportunity, rescission notice, and patient protection disclosure requirements that are subject to the Paperwork Reduction Act of 1995. The enrollment opportunity notice was to be used by health plans to notify certain individuals of their right to re-enroll in their plan. The affected individuals were those whose coverage ended due to reaching a lifetime limit on the dollar value of all benefits for any individual. This notice was a one-time requirement and is being discontinued. The rescission notice will be used by health plans to provide advance notice to certain individuals that their coverage may be rescinded. The affected individuals are those who are at risk of rescission on their health insurance coverage. The patient protection notification will be used by health plans to inform certain individuals of their right to choose a primary care provider or pediatrician and to use obstetrical/gynecological services without prior authorization. 2016-08-31-04:00 Active Jamaa Hill 301 492-4190 No Yes No 1586022 1842 42662

Section 2711 - Lifetime limits No Health Health Care Services State, Local, and Tribal Governments 0 0 0

Section 2712 - Rules regarding rescissions No Health Health Care Services Private Sector 10206 266 3267

Section 2719A - Patient Protections No Health Health Care Services State, Local, and Tribal Governments 1575816 1576 39395

2013-08-16-04:00

0938-1095 201112-0938-007 0938
             
        "Application for Coverage in the Pre-Existing Condition Insurance Plan"
             
          
        
An eligible individual who wishes to apply for health insurance coverage under the PCIP program must complete and submit an enrollment application. The enrollment application includes vital pieces of information used to verify the applicant is eligible for the PCIP program and enroll applicants deemed to be eligible. Individuals who have not had prior creditable coverage within the past 6 months, are a US Citizen or lawfully present, and have a pre-existing condition may apply for coverage under the PCIP program. 2015-03-31-04:00 Active William Parham 4107864669 No Yes No 83333 59833 0

Application and Eligibility (2010) No Health Health Care Services
CMS-10334 PCIP Application Yes No Fillable Fileable Form and instruction CMS-10334. CLEAN - Revised PCIP Application.doc
Individuals or Households 0 0 0

Premium Payment (2010) No Health Health Care Services
CMS-10334 PCIP Application Yes No Fillable Fileable Form and instruction CMS-10334. CLEAN - Revised PCIP Application.doc
Individuals or Households 0 0 0

Application and Eligibility (2011) No Health Health Care Services
CMS-10334 PCIP Application Yes No Fillable Fileable Form and instruction CMS-10334. CLEAN - Revised PCIP Application.doc
Individuals or Households 0 0 0

Premium Payment (2011) No Health Health Care Services
CMS-10334 PCIP Application Yes No Fillable Fileable Form and instruction CMS-10334. CLEAN - Revised PCIP Application.doc
Individuals or Households 0 0 0

Application and Eligibility (2012) No Health Health Care Services
CMS-10334 PCIP Application Yes No Fillable Fileable Form and instruction CMS-10334. CLEAN - Revised PCIP Application.doc
Individuals or Households 0 0 0

Premium Payment (2012) No Health Health Care Services
CMS-10334 PCIP Application Yes No Fillable Fileable Form and instruction CMS-10334. CLEAN - Revised PCIP Application.doc
Individuals or Households 0 0 0

Application and Eligibility (2013) No Health Health Care Services
CMS-10334 PCIP Application Yes No Fillable Fileable Form and instruction CMS-10334. CLEAN - Revised PCIP Application.doc
Individuals or Households 0 0 0

Premium Payment (2013) No Health Health Care Services
CMS-10334 PCIP Application Yes No Fillable Fileable Form and instruction CMS-10334. CLEAN - Revised PCIP Application.doc
Individuals or Households 0 0 0

Application and Eligibility Burden No Health Health Care Services
CMS-10334 PCIP Application Yes No Fillable Fileable Form and instruction CMS-10334.Draft PCIP Application.doc
Individuals or Households 50000 54500 0

Premium Payment Burden No Health Health Care Services
CMS-10334 PCIP Application Yes No Fillable Fileable Form and instruction CMS-10334.Draft PCIP Application.doc
Individuals or Households 33333 5333 0

2012-03-20-04:00

0938-1097 201212-0938-004 0938
             
        "Consumer Assistance Program Grants"
             
          
        
Pursuant to section 2793(d) of the Public Health Services Act (PHSA), as amended by Section 1002 of the ACA, as a condition for receiving the consumer assistance program grant, programs must collect and report data to the Secretary on the types of problems and inquiries encountered by consumers. Accordingly, program staff will need a system to maintain case files that will track these types of problems and inquiries. Problems and inquiries will be summarized and will be reported to HHS. By law, the user of the summary data is the Secretary of HHS and will be used for oversight. Further, ACA dictates that the Secretary will share these reports with the Department of Labor and Treasury, and with State insurance regulators for use in enforcement. 2016-03-31-04:00 Active William Parham 4107864669 No Yes No 560 16184 0

Data Collection Report (Initial Submission) No Health Health Care Services
CMS-10333 Appendix 1 No No Fillable Fileable Form and instruction CMS-10333 Appendix 1_Screenshots of CCIIO-Developed Database.pdf
State, Local, and Tribal Governments 56 1568 0

Data Collection Report (Quarterly and Annual Reports) No Health Health Care Services
CMS-10333 Appendix 2 Yes Yes Fillable Fileable Form and instruction CMS-10333 Appendix 2_Template for the Quarterly Progress Report.pdf CMS-10333 Appendix 3 Yes Yes Fillable Fileable Form and instruction CMS-10333 Appendix 3_Template for the Annual Report.pdf
State, Local, and Tribal Governments 504 14616 0

2013-03-05-05:00

0938-1098 201307-0938-027 0938
             
        "Tribal Consultation State Plan Amendment Template (CMS-10293)"
             
          
        
Section 5006 of the American Recovery and Reinvestment Act of 2009, Public Law 111-5, amends section 1902(a)(73)of the Social Security Act effective July 1, 2009, to require States in which one or more Indian Health Programs or Urban Indian Organizations furnish health care services to establish a process for the State Medicaid agency to seek advice on a regular, ongoing basis from designees of the Indian Health Service and Urban Indian Organization concerning Medicaid matters having a direct impact on them. The State Medicaid agency for each of these States will complete the template page and submit it for approval as part of a State plan amendment, to document how it meets the requirements for tribal consultation. 2016-10-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 Yes No No 37 37 0

Tribal Consultation State Plan Amendment Template (CMS-10293) No Health Health Care Services
CMS-10293 State Plan Amendment Template for Trival Consultation Under Title XIX of the Social Security Act Yes Yes Fillable Fileable Form and instruction Preprint 5006 4-28-10.docx
State, Local, and Tribal Governments 37 37 0

2013-10-23-04:00

0938-1099 201303-0938-001 0938
             
        "Affordable Care Act Internal Claims and Appeals and External Review Procedures for Non-grandfathered Group Health Plans and Issuers and Individual Market Issuers "
             
          
        
The information collection requirements included in the claims procedure regulation ensure that participants and beneficiaries (claimants) receive adequate information regarding the plan's claims procedures and the plan's handling of specific benefit claims. Participants and beneficiaries need to understand plan procedures and plan decisions in order to appropriately request benefits and/or appeal benefit denials. The information collection requirements are necessary for the Federal external review process to provide an independent external review as requested by claimants. 2016-08-31-04:00 Active Jamaa Hill 301 492-4190 No Yes No 218000000 930000 52000000

Burden Estimates No Health Health Care Services
CMS-10338 CMS-10338 external_final_decision_model_notice Yes No Fillable Fileable Form and instruction CMS-10338 external_final_decision_model_notice.pdf CMS-10338 CMS-10338 final_iabd_model_notice Yes No Fillable Fileable Form and instruction CMS-10338 final_iabd_model_notice.pdf CMS-10338 CMS-10338 abd_model_notice Yes No Fillable Fileable Form and instruction CMS-10338 abd_model_notice.pdf Yes No Fillable Fileable Instruction CMS-10338 Letter to Issuers in Territories.pdf Yes No Fillable Fileable Instruction CMS-10338 Letter to Issuers.pdf
Private Sector 218000000 930000 52000000

2013-08-12-04:00

0938-1100 201308-0938-003 0938
             
        "Pre-Existing Condition Insurance Plan and Supporting Regulations "
             
          
        
The Department of Health and Human Services (HHS) is requesting an extension of this currently approved information collection request. HHS is now seeking a three-year approval for this collection. On March 23, 2010, the President signed into law H.R. 3590, the Patient Protection and Affordable Care Act (Affordable Care Act), Public Law 111-148. Section 1101 of the law establishes a ''temporary high risk health insurance pool program'' (which has been named the Pre-Existing Condition Insurance Plan, or PCIP) to provide health insurance coverage to currently uninsured individuals with pre-existing conditions. The law authorizes HHS to carry out the program directly or through contracts with states or private, non-profit entities. We are requesting an extension for this package because this information is needed to assure that PCIP programs are established timely and effectively. This request is being made based on regulations that have been issued and contracts which have been executed by HHS with States or an entity on their behalf participating in the PCIP program. PCIP is also referred to as the temporary qualified high risk insurance pool program, as it is called in the Affordable Care Act, but we have adopted the term PCIP to better describe the program and avoid confusion with the existing state high risk pool programs. 2016-09-30-04:00 Active William Parham 4107864669 No Yes No 2652 36924 0

Payment Invoices (42 CFR 152.32) No Health Health Care Services State, Local, and Tribal Governments 612 9792 0

Fraud, Waste, and Abuse (42 CFR 152.27) No Health Health Care Services State, Local, and Tribal Governments 612 2448 0

Quarterly and Monthly Reporting No Health Health Care Services
CMS-10339 State Solicitation Yes Yes Fillable Fileable Form and instruction CMS-10339.state_solicitation.pdf CMS-10339 Contract Template Yes Yes Fillable Fileable Form and instruction CMS-10339.HHS Template Contract.docx
State, Local, and Tribal Governments 612 14688 0

Audited Financial Report No Health Health Care Services
CMS-10339 State Solicitation Yes Yes Fillable Fileable Form and instruction CMS-10339.state_solicitation.pdf CMS-10339 Template Contract Yes Yes Fillable Fileable Form and instruction CMS-10339.HHS Template Contract.docx
State, Local, and Tribal Governments 51 1224 0

Reports of Insurer Dumping (42 CFR 152.28) No Health Health Care Services State, Local, and Tribal Governments 612 4896 0

Audit No Health Health Care Services
CMS-10339 State Solicitation Yes Yes Fillable Fileable Form and instruction CMS-10339.state_solicitation.pdf CMS-10339 Tempate Contract Yes Yes Fillable Fileable Form and instruction CMS-10339.HHS Template Contract.docx
State, Local, and Tribal Governments 51 2040 0

Record Retention No Health Health Care Services
CMS-10339 Template Contract Yes Yes Fillable Fileable Form and instruction CMS-10339.HHS Template Contract.docx CMS-10339 State Solicitation Yes Yes Fillable Fileable Form and instruction CMS-10339.state_solicitation.pdf
State, Local, and Tribal Governments 51 612 0

Proposal Modification No Health Health Care Services
CMS-10339 Template Contract Yes Yes Fillable Fileable Form and instruction CMS-10339.HHS Template Contract.docx CMS-10339 State Solicitation Yes Yes Fillable Fileable Form and instruction CMS-10339.state_solicitation.pdf
State, Local, and Tribal Governments 51 1224 0

2013-09-20-04:00

0938-1102 201307-0938-023 0938
             
        "Medicare Quality of Care Complaint Form"
             
          
        
In accordance with Section 1154(a)(14) of the Social Security Act, QIOs are required to conduct appropriate reviews of all written complaints submitted by beneficiaries concerning the quality of care received. This form will establish a standard form for all beneficiaries to utilize and ensure pertinent information is obtained by QIOs to effectively process these complaints. 2016-11-30-05:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 3500 583 0

Medicare Quality of Care Complaint Form No Health Health Care Services
CMS-10287 Crosswalk Yes Yes Fillable Fileable Form and instruction Crosswalk CMS 0938 1102.pdf CMS-10287 Medicare Quality of Care Complaint Form Yes Yes Fillable Fileable Form and instruction Complaint Form.docx
Individuals or Households 3500 583 0

2013-11-21-05:00

0938-1103 201107-0938-002 0938
             
        "Medicare Gainsharing Demonstration Evaluation: Physician Focus Groups "
             
          
        
The proposed physician focus groups are part of the evaluation of the Centers for Medicare and Medicaid Services (CMS)'s Medicare Physician Hospital Collaboration Demonstration. The Congress, under Section 646 of the Medicare Modernization Act (MMA) of 2003 permitted CMS to conduct demonstrations to test methods for the provision of incentives for improving the quality and safety of care and achieving the efficient allocation of resources. The primary goal of the demonstration is to evaluate gainsharing as means to align physician and hospital incentives to improve quality and efficiency. This demonstration plans to use the physician focus group protocols approved by OMB for the DRA 5007 Gainsharing Demonstration (OCN 0938-1103). 2014-10-31-04:00 Active William Parham 4107864669 No No No 288 288 0

Medicare Gainsharing Demonstration Evaluation: Physician Focus Groups (CMS-10303) No Health Health Care Services
CMS-10303 Advance Letters and Focus Group Discussion Protocols No No Fillable Fileable Form and instruction CMS-10303.Attachments C and D.pdf
Private Sector 288 288 0

2011-10-23-04:00

0938-1105 201106-0938-022 0938
             
        "Process for Obtaining Waivers of the Annual Limits Requirements of PHS Act Section 2711"
             
          
        
The annual limits waiver application process is used by The Department of Health and Human Services (HHS) to consider information provided by health insurance issuers, group health plans and State applicants, and to make determinations to approve or deny waivers of the annual limits applications. The process includes an application, issuance of model notices, and an attestation requirement. 2015-02-28-05:00 Active William Parham 4107864669 No Yes No 4608372 178183 2256818

Waiver Process No Health Health Care Services Private Sector 2500 25000 0

Model Notices No Health Health Care Services Private Sector 4605750 153000 2256818

Attestation Requirement No Health Health Care Services Private Sector 122 183 0

2012-02-27-05:00

0938-1106 201103-0938-015 0938
             
        "Medicare Self-Referral Disclosure Protocol"
             
          
        
This information collection request identifies the specific information describing the actual or potential violation(s) and the related financial analysis that must be furnished by providers of services and suppliers as part of their voluntary disclosure submissions under section 6409 of the Affordable Care Act. 2014-05-31-04:00 Active William Parham 4107864669 No Yes No 100 1200 0

Legal Review No Health Health Care Services
CMS-10328 Medicare Self-Referral Disclosure Protocol Yes Yes Fillable Fileable Form and instruction 6409 SRDP Protocol 1-5-11.docx
Private Sector 50 750 0

Financial Review No Health Health Care Services
CMS-10328 Medicare Self-Referral Disclosure Protocol Yes Yes Fillable Fileable Form and instruction 6409 SRDP Protocol 1-5-11.docx
Private Sector 50 450 0

2011-05-06-04:00

0938-1109 201312-0938-017 0938
             
        "Hospital Outpatient Quality Data Program (HOPQDRP) (CMS-10250)"
             
          
        
This information is used by CMS to direct its contractor, including Quality Improvement Organizations (QIOs), to focus on particular areas of improvement, and to develop quality improvement initiatives. The information is made available to hospitals for their use in internal quality improvement initiatives. Most importantly, this information is available to Medicare beneficiaries, as well as to the general public, to provide hospital information to assist them in making decisions about their health care. 2017-02-28-05:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No Yes No 5071000 2906749 0

Hospital Outpatient Quality Data Program (HOPQDRP) - Abstracting Burden (CY 2009 and CY2010) No Health Health Care Services Private Sector 0 0 0

Hospital Outpatient Quality Data Program (HOPQDRP) - Notice of Participation (2010) No Health Health Care Services
CMS-10250 CMS-10250.Notice of Participation Yes Yes Fillable Fileable Form and instruction CMS-10250.Notice of Participation.doc
Private Sector 0 0 0

Hospital Outpatient Quality Data Program (HOPQDRP) - CY 2011 Data Validation No Health Health Care Services Private Sector 0 0 0

Hospital Outpatient Quality Data Program (HOPQDRP) - Notice of Participation (2011) No Health Health Care Services
CMS-10250 CMS Notice of Participation Yes Yes Fillable Fileable Form and instruction CMS-10250.Notice_of_Participation.doc
Private Sector 0 0 0

Hospital Outpatient Quality Data Program (HOPQDRP) CY 2011 Data Abstraction No Health Health Care Services Private Sector 0 0 0

Hospital Outpatient Quality Data Program - Data Abstraction (CY 2014) No Health Health Care Services Private Sector 1628800 949590 0

Hospital Outpatient Quality Data Program - Notice of Participation (CY 2014) No Health Health Care Services
CMS-10250 Request for Reconsideration Part 1 Yes Yes Fillable Fileable Form and instruction HosOQR_ReconFormPart1_012313.pdf CMS-10250 Request for Reconsideration Part 2 Yes Yes Fillable Fileable Form and instruction HosOQR_ReconFormPart_2_012313.pdf CMS-10250 Extroadinary Circumstances Yes Yes Fillable Fileable Form and instruction ExtrordryCrcmstncForm-f_011813.pdf CMS-10250 Notice of Participation Yes Yes Fillable Fileable Form and instruction OQR_NOP final.docx
Private Sector 16000 2672 0

Hospital Outpatient Quality Data Program - Data Validation (CY 2014) No Health Health Care Services Private Sector 24000 6000 0

Hospital Outpatient Quality Data Program - Data Abstraction (CY 2015) No Health Health Care Services Private Sector 1628800 949590 0

Hospital Outpatient Quality Data Program - Notice of Participation (CY 2015) No Health Health Care Services
CMS-10250 Notice of Participation Yes Yes Fillable Fileable Form and instruction OQR_NOP final.docx
Private Sector 16000 2672 0

Hospital Outpatient Quality Data Program - Data Validation (CY 2015) No Health Health Care Services Private Sector 24000 6000 0

Hospital Outpatient Quality Data Program - Data Abstration (CY 2016) No Health Health Care Services Private Sector 1679700 979265 0

Hospital Outpatient Quality Program - Notice of Participation (CY 2016) No Health Health Care Services
CMS-10250 Notice of Participation Yes Yes Fillable Fileable Form and instruction OQR_NOP final.docx
Private Sector 29700 4960 0

Hospital Outpatient Quality Data Program - Data Validation (CY 2016) No Health Health Care Services Private Sector 24000 6000 0

2014-02-06-05:00

0938-1111 201009-0938-005 0938
             
        "Electronic Submission of Medicare GME Affiliation Agreements"
             
          
        
As discussed in the FY2011 Inpatient Prospective Payment System final rule, we will allow hospitals to electronically submit the copy of the affiliation agreement that is required to be sent to the CMS Central Office. The electronic submission process consists of either an email mailbox or a Web site where hospitals must submit their Medicare GME affiliation agreements to the CMS Central Office to a designated online mailbox. A copy of the Medicare GME affiliation agreement must be received through the electronic system no later than 11:59 p.m. on July 1 of each academic year. The electronic affiliation agreement must be submitted either as a scanned copy or a Printer-Friendly Display (PDF) version of that hard copy agreement; we will not accept an agreement in any electronic format that could be subject to manipulation. The scanned and/or PDF format will enable CMS to ensure that the agreements are signed and dated as required in the regulations at 42 CFR 413.75. Hospitals will have the option to continue to submit a hard copy of its affiliation agreement to the CMS Central Office. In addition, each fiscal intermediary or MAC will continue to have the authority to specify its requirements for submittal of the Medicare GME affiliation agreement by hospitals that are part of the affiliation. 2014-02-28-05:00 Active William Parham 4107864669 No No No 375 166 0

Development of Agreement No Health Health Care Services
CMS-10326 Sample Affiliation Agreement Yes Yes Fillable Fileable Form CMS-10326.Sample Affiliation Agreement (8-13-10).doc
Private Sector 125 125 0

Hardcopy Submission to FI or MAC No Health Health Care Services
CMS-10326 Sample Affiliation Agreement Yes Yes Fillable Fileable Form CMS-10326.Sample Affiliation Agreement (8-13-10).doc
Private Sector 125 31 0

Electronic Submission to CMS No Health Health Care Services
CMS-10326 Sample Affiliation Agreement Yes Yes Fillable Fileable Form CMS-10326.Sample Affiliation Agreement (8-13-10).doc
Private Sector 125 10 0

2010-10-29-04:00

0938-1113 201307-0938-003 0938
             
        "Implementation of the Medicare Prescription Drug Plan (PDP) and Medicare"
             
          
        
This information collection will survey disenrollees from Medicare Prescription Drug Plans (PDPs) and Medicare Advantage Prescription Drug Plans (MA-PDs). The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) provides a requirement to collect and report performance data for Part D prescription drug plans. Specifically, the MMA under Sec. 1860D-4 (Beneficiary Protections for Qualified Prescription Drug Coverage) requires CMS to conduct consumer satisfaction surveys regarding PDPs and MA-PDs - pursuant to section 1860D-4(d). This data collection complements the satisfaction data collected through the Medicare CAHPS Survey by providing dissatisfaction data in the form of reasons for disenrollment from PDPs and MA-PDs. 2016-10-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 88492 22887 0

Medicare Disenrollment Survey - Stand Alone PDP Version (CMS-10316) No Health Health Care Services
CMS-10316 Medicare Disenrollee Survey: Prescription Drug Plan No No Fillable Printable Form Attachment 4 - PDP Survey.docx
Individuals or Households 19791 4750 0

Medicare Disenrollee Survey - MA-PD (CMS-10316) No Health Health Care Services
CMS-10316 Medicare Disenrollee Survey - MA PD No No Fillable Printable Form Attachment 3 - MA-PD Survey.docx
Individuals or Households 61831 16694 0

Medicare Disenrollee Survey - MA (CMS-10316) No Health Health Care Services
CMS-10316 Medicare Disenrollee Survey - MA No No Fillable Printable Form Attachment 5 - MA Only Survey.docx
Individuals or Households 6870 1443 0

2013-10-24-04:00

0938-1114 201105-0938-017 0938
             
        "Medical Loss Ratio (IFR) Information Collection Requirements and Supporting Regulations"
             
          
        
Section 2718 of the Public Health Service Act (PHS Act) requires health insurance issuers offering group or individual health insurance coverage to submit an annual report to the Secretary beginning in 2012. The reported data will allow for the calculation of an issuer's medical lass ratio (MLR) by market (individual, small group, and large group) within each State in which the issuer conducts business. Section 2718 sets out a minimum MLR standard for each market segment that issuers must meet. If an issuer doed not meet the MLR standard, it must provide rebates to enrollees. Section 2718 allows for the Secretary to lower the 80% MLR standard in the individual market on a state-by-state basis if there is a risk of destabilization caused by the requirement to meet the MLR standard. States requesting that HHS lower the MLR standard must submit information supporting their assertion that the individual market in their State would destabilize absent an adjustment to the MLR standard. HHS must obtain such information in order to ascertain whether destabillization has a high likelihood of occuring within the respective State. 2014-08-31-04:00 Active William Parham 4107864669 No Yes No 462 4142 0

Waiver Application No Health Health Care Services State, Local, and Tribal Governments 20 3700 0

Record Retention Requirement No Health Health Care Services Private Sector 442 442 0

2011-08-12-04:00

0938-1115 201009-0938-021 0938
             
        "Medicare Part C and Part D Data Validation (42 C.F.R. 422.516g and 423.514g)"
             
          
        
CMS' regulatory authority to require data validation is described in 42 CFR 422.516(g) and 423.514(g). Organizations contracted to offer Medicare Part C and Part D benefits are required to report data to CMS on a variety of measures. In order for the data to be useful for monitoring and performance measurement, the data must be reliable, valid, complete, and comparable among sponsoring organizations. To meet this goal, CMS has developed reporting standards and data validation specifications with respect to the Part C and Part D reporting requirements. These standards provide a review process for Medicare Advantage Organizations (MAOs), Cost Plans, and Part D sponsors to use to conduct independent data validation checks on their reported Part C and Part D data to determine their reliability, validity, completeness, and comparability in accordance with specifications developed by CMS. 2014-02-28-05:00 Active Bonnie Harkless 4107865666 No No No 634 237127 0

Medicare Part C and Part D Data Validation (42 C.F.R. 422.516g and 423.514g) - (CMS-10305) No Health Health Care Services
CMS-10305 Medicare Part C and Part D Measure Organizational Assessment Instrument Yes Yes Paper Only Form and instruction 1 DRAFT Organizational Assessment Instrument 20100826_508.pdf Yes Yes Paper Only Instruction 2 DRAFT_Data Extraction and Sampling Instructions_20100826_508.pdf Yes Yes Paper Only Instruction 3 DRAFT Data Validation Standards 20100826_508.pdf CMS-10305 Findings Data Collection Form: Benefit Utilization Yes Yes Paper Only Form 5 DRAFT Findings Data Collection Form_20100826_508.pdf Yes Yes Paper Only Instruction 4 DRAFT Findings Data Collection Form Intro_20100826_508.pdf
Private Sector 634 237127 0

2010-11-23-05:00

0938-1119 201308-0938-024 0938
             
        "Cooperative Agreement to Support Establishment of State-Operated Health Insurance Exchanges"
             
          
        
Information collected as a part of the application for this grant will be used to evaluate the applications and determine awardees. Information collected pursuant to the reporting requirements for awardees will be used to evaluate the progress of States in planning for and implementing Exchanges, and determine how the Secretary can provide assistance to achieve the goals of the grant program and the Affordable Care Act. 2016-09-30-04:00 Active William Parham 4107864669 No Yes No 1068 67884 28081

Application No Health Health Care Services
CMS-10371 Revised FOA Yes No Fillable Fileable Form and instruction FOA - IE-HBE-11-004.pdf
State, Local, and Tribal Governments 40 22560 28081

Performance Reviews No Health Health Care Services
CMS-10371 Revised FOA Yes No Fillable Fileable Form and instruction FOA - IE-HBE-11-004.pdf
State, Local, and Tribal Governments 16 3760 0

Periodic Reporting No Health Health Care Services
CMS-10371 Revised FOA Yes No Fillable Fileable Form and instruction FOA - IE-HBE-11-004.pdf
State, Local, and Tribal Governments 48 11280 0

Public No Health Health Care Services
CMS-10371 Revised FOA Yes No Fillable Fileable Form and instruction FOA - IE-HBE-11-004.pdf
State, Local, and Tribal Governments 160 1360 0

Semi-Annual Reports No Health Health Care Services
CMS-10371 Establishment Grant FOA No No Fillable Fileable Form and instruction 2012 Exchange Establishment FOA 02_21_12 clean for PRA posting DRAFT.docx
State, Local, and Tribal Governments 80 9712 0

Work Plan Update No Health Health Care Services
CMS-10371 Revised FOA Yes No Fillable Fileable Form and instruction FOA - IE-HBE-11-004.pdf
State, Local, and Tribal Governments 80 160 0

Start-up Outcomes Metrics - Quarterly Reports No Health Health Care Services
CMS-10371 Start-up Outcomes Metrics - Quarterly Reports Yes Yes Fillable Fileable Form and instruction CMS-10371 - Data Elements Start up Outcomes Metrics Quarter_508 pdf - Adobe Acrobat Pro.pdf CMS-10371 Outcome Metric amp;#8211; SBM Exchange Metrics Yes Yes Fillable Fileable Form and instruction 0938-1119. (Outcome Metric) SBM Exchange Metrics 20130829 pg layout.xlsx
State, Local, and Tribal Governments 64 1152 0

Outcome Metrics - Annual Report No Health Health Care Services
CMS-10371 Outcome Metrics - Annual Report Yes Yes Fillable Printable Form and instruction CMS-10371 - Data Elements Startup Outcomes Metrics Annual_508.pdf CMS-10371 Outcome Metric amp;#8211; SBM Exchange Metrics Yes Yes Fillable Fileable Form and instruction 0938-1119. (Outcome Metric) SBM Exchange Metrics 20130829 pg layout.xlsx
State, Local, and Tribal Governments 16 640 0

Operational Metrics - Monthly Reports No Health Health Care Services
CMS-10371 Operational Metric amp;#8211; SBM Open Enrollment Weekly Indicators Yes Yes Fillable Fileable Form and instruction 0938-1119 (Operational Metric) SBM Open Enrollment Weekly Indicators Rev 9_5_2013 Word-508.pdf CMS-10371 Exchange Establishment Grants FOA No No Fillable Fileable Form and instruction 2012 Exchange Establishment FOA 02_21_12 clean for PRA posting DRAFT.docx
State, Local, and Tribal Governments 96 2304 0

Operational Metrics - Weekly Reports No Health Health Care Services
CMS-10371 Exchange Establishment Grant FOA Yes Yes Fillable Fileable Form and instruction 2012 Exchange Establishment FOA 02_21_12 clean for PRA posting DRAFT.docx CMS-10371 Operational Metric amp;#8211; SBM Open Enrollment Weekly Indicators Yes Yes Fillable Fileable Form and instruction 0938-1119 (Operational Metric) SBM Open Enrollment Weekly Indicators Rev 9_5_2013 Word-508.pdf
State, Local, and Tribal Governments 416 9984 0

Start-Up Year Establishment Review No Health Health Care Services State, Local, and Tribal Governments 32 2752 0

Develpomental Phase Planning Review No Health Health Care Services
CMS-10371 Exchange Establishment Grant FOA Yes Yes Fillable Fileable Form and instruction 2012 Exchange Establishment FOA 02_21_12 clean for PRA posting DRAFT.docx
State, Local, and Tribal Governments 20 2220 0

2013-09-30-04:00

0938-1121 201308-0938-004 0938
             
        "Cycle I, II, and III - "Grants to Support States in Health Insurance Rate Review and Pricing Transparency" Reporting"
             
          
        
Cycle I Process - The data collection is used by HHS to request that States and territories submit the following: oFour quarterly reports to the Secretary detailing the States' progression towards a more comprehensive rate review process, utilizing funds awarded in Cycle I Rate Review Grants. oRate review transaction data collected by the State. oOne final Cycle I report Reporting of information by grant awardees will assist HHS to perform oversight of federal grants. Cycle II Process - The data collection is used by HHS to request that States and territories submit the following: oFour quarterly reports to the Secretary detailing the States' progression towards a more comprehensive rate review process, utilizing funds awarded in Cycle II Rate Review Grants. oRate review transaction data collected by the State. oOne annual report. oOne final report at the end of the grant. Cycle III Process - The data collection will be used by HHS to request that States and territories submit the following: oAn application to apply for the Cycle III Rate Review Grants. Guidance requirements for the application are provided in the Funding Opportunity Announcement, beginning in Section 3, entitled "Program Requirements". oFour quarterly reports to the Secretary detailing the States' enhancements of their rate review programs or Data Centers. Data elements have been adjusted in order to enhance reporting on Data Center activities. oRate review transaction data collected by the State. oOne annual report. oOne final report at the end of the grant. This information will assist HHS in planning for and executing grants to States for rate review and Data Center activities. In addition, reporting of information by grant awardees will assist HHS in assuring that grant awardees report and share data with the Secretary as required by the statute. 2016-09-30-04:00 Active William Parham 4107864669 No Yes No 1463 55400 0

(Cycle I) Quarterly Reports No Health Health Care Services
CMS-10380 Cycle I - Quarterly Report No No Fillable Printable Form and instruction Grant Cycle I Quarterly Report Template.pdf
State, Local, and Tribal Governments 20 480 0

(Cycle I) Transaction Data Collection No Health Health Care Services
CMS-10380 Cycle I FOA Yes No Fillable Fileable Form and instruction grant to states for health insurance premium review - cycle 1.doc
State, Local, and Tribal Governments 204 8160 0

(Cycle II) Application No Health Health Care Services
CMS-10380 Cycle II - FOA Yes No Fillable Fileable Form and instruction Cycle II Rate Review Grants FOA (2-24-11@1130am).docx
State, Local, and Tribal Governments 0 0 0

(Cycle II) Quarterly Report No Health Health Care Services
CMS-10380 Cycle II - Quarterly Report Template Yes Yes Fillable Fileable Form and instruction Grant_Cycle_II_Quarterly_Report_Template-a.pdf CMA-10380 Cycle II FOA Yes Yes Fillable Fileable Form and instruction Cycle II Rate Review Grants FOA (2-24-11@1130am).docx
State, Local, and Tribal Governments 224 5376 0

(Cycle II) Transaction Data Collection No Health Health Care Services
CMS-10380 Cycle II FOA Yes Yes Fillable Fileable Form and instruction Cycle II Rate Review Grants FOA (2-24-11@1130am).docx
State, Local, and Tribal Governments 224 8960 0

(Cycle II) Annual Report No Health Health Care Services
CMS-10380 Cycle II FOA Yes Yes Fillable Fileable Form and instruction Cycle II Rate Review Grants FOA (2-24-11@1130am).docx
State, Local, and Tribal Governments 34 1360 0

(Cycle II ) Final Report - end of grant No Health Health Care Services
CMS-10380 Cycle II FOA Yes Yes Fillable Fileable Form and instruction Cycle II Rate Review Grants FOA (2-24-11@1130am).docx
State, Local, and Tribal Governments 34 1360 0

(Cycle I) Final Report No Health Health Care Services
CMS-10380 Cycle 1 - Final report template Yes Yes Fillable Fileable Form and instruction Grant Cycle I Final Report Template.pdf CMS-10380 Cycle I FOA Yes Yes Fillable Fileable Form and instruction grant to states for health insurance premium review - cycle 1.doc
State, Local, and Tribal Governments 51 2040 0

(Cycle III) Application No Health Health Care Services State, Local, and Tribal Governments 56 8960 0

(Cycle III) Quarterly Report No Health Health Care Services
CMS-10380 Cycle III - Quarterly Report Template Yes Yes Fillable Fileable Form and instruction Grant_Cycle_III_Quarterly_Report_Template-a.pdf
State, Local, and Tribal Governments 224 5824 0

(Cycle III) Transaction Data Collection No Health Health Care Services
CMS-10380 Cycle III - Data Yes Yes Paper Only Form and instruction CMS-10380 - Rate Review Grant Program Data Dictionary_0713.pdf
State, Local, and Tribal Governments 280 8400 0

(Cycle III) Annual Report No Health Health Care Services
CMS-10380 Cycle III - Annual Reporting Template Yes Yes Fillable Fileable Form and instruction Grant_Cycle_III_Annual_Report_Template-a.pdf
State, Local, and Tribal Governments 56 2240 0

(Cycle III) Final Report No Health Health Care Services
CMS-10380 Cycle III - Final Report Template Yes Yes Fillable Fileable Form and instruction Grant_Cycle_III_Final_Report_Template-a.pdf
State, Local, and Tribal Governments 56 2240 0

2013-09-09-04:00

0938-1123 201102-0938-013 0938
             
        "MMIS APD Template for Use by States When Implementing the Mandatory National Correct Coding Initiative in Medicaid, implementation of Section 6507 of ACA (CMS-10358)"
             
          
        
An MMIS APD template is required for States to request FFP funding for implementing the provision and is also the tool for requesting deactivation of edits, due to direct conflicts with State laws, regulations, administrative rules, or payment policies. CMS has developed an MMIS-APD template specific to NCCI for State convenience. 2014-03-31-04:00 Active Eulanda Grigg 410 786-7202 No Yes No 56 168 0

MMIS APD Template for Use by States When Implementing the Mandatory National Correct Coding Initiative in Medicaid No Health Health Care Services State, Local, and Tribal Governments 56 168 0

2011-03-28-04:00

0938-1125 201110-0938-003 0938
             
        "Expedited Checklist: Medicaid Eligibility & Enrollment Systems -  Advance Planning Document  (E&E-APD ) (CMS-10385)"
             
          
        
The Patient Protection and Affordable Care Act (the Affordable Care Act) applies new Medicaid eligibility and enrollment business rules for seamless coordination between the Medicaid and CHIP programs, and the Health Insurance Exchanges, known as "the Exchanges". In cases where the State's Medicaid Management Information System (MMIS), State's Eligibility System(s), or State's Exchange requires the support of system development and/or enhancement activities, States are eligible to receive FFP at the enhanced rate, if the system(s) will be designed and implemented to meet the seven standards and conditions. CMS has developed the Expedited Checklist: Medicaid Eligibility & Enrollment Information System(s) - Advance Planning Document (E&E-APD) specific to this purpose, for eligibility and enrollment system developments for State convenience. 2014-11-30-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 168 840 0

Expedited Checklist: Medicaid Eligibility & Enrollment Systems - Advance Planning Document (E&E-APD) (CMS-10385) No Health Health Care Services
CMS-10385 Expedited Checklist: Medicaid Eligibility & Enrollment Information System(S) - Advance Planning Document (E&E - APD) Yes No Fillable Printable Form and instruction Medicaid Expedited EE APD Checklist [rev 10-06-11].doc
State, Local, and Tribal Governments 168 840 0

2011-11-07-05:00

0938-1126 201103-0938-008 0938
             
        "State Plan Preprint for Medicaid Recovery Audit Contractor (RAC) Program (CMS-10343)"
             
          
        
To provide a mechanism for States to attest that they will establish a Medicaid RAC program and to allow them to amend the State Plan Amendment to reflect how they will tailor the Medicaid RAC's activities to the uniqueness of the Medicaid program in their State, as well as identify and propose targeted areas or susceptibility regarding improper payments. 2014-04-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 56 56 0

State Plan Preprint for Medicaid Recovery Audit Contractor (RAC) Program (CMS-10343) No Health Health Care Services State, Local, and Tribal Governments 56 56 0

2011-04-25-04:00

0938-1127 201101-0938-003 0938
             
        "Elimination of Cost-Sharing for full benefit dual-eligible Individuals Receiving Home and Community-Based Services"
             
          
        
This provision is mandated by the Affordable Care Act, section 3309. To implement this provision, CMS needs data from the States, identifying full benefit dual-eligible individuals who are receiving home and community-based services. The States will provide these data as a new data value on their monthly MMA Phase Down report. These data are not available from any other source. CMS will use these new data to set the affected beneficiaries' Medicare Part D copayment to zero. 2014-04-30-04:00 Active Bonnie Harkless 4107865666 No Yes No 663 1632 0

Elimination of Cost-Sharing for full benefit dual-eligible Individuals Receiving Home and Community-Based Services (CMS-10344) No Health Health Care Services State, Local, and Tribal Governments 51 1020 0

Elimination of Cost-Sharing for full benefit dual-eligible Individuals Receiving Home and Community-Based Services (Annual - effective 1/1/2012) No Health Health Care Services State, Local, and Tribal Governments 612 612 0

2011-04-25-04:00

0938-1128 201103-0938-011 0938
             
        "Medicaid State Plan Preprint for Use by States When Implementing Section 6505, the Prohibition on Payments to Institutions or Entities Located Outside of the United States"
             
          
        
The Patient Protection and Affordable Care Act (Affordable Care Act) requires implementation of Section 6505, Prohibition on Payments to Institutions or Entities Located Outside of the United States. A State Medicaid Director letter will provide guidance to States on this provision and includes as an Enclosure, the Medicaid State Plan Preprint. Within this SMD letter, CMS states that the Medicaid State Plan Preprint is required for States to assure to CMS compliance to the Section 6505 provision. CMS has developed the Medicaid State Plan Preprint for Section 6505 for State convenience. 2014-05-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 56 5 0

Medicaid State Plan Preprint for Use by States When Implementing Section 6505, the Prohibition on Payments to Institutions or Entities Located Outside of the United States. No Health Health Care Services
CMS-10367 6505 SMD State Plan Preprint submitted for Clearance Yes Yes Fillable Printable Form 6505 SMD State Plan Preprint submitted for Clearance(2)12142010.doc
State, Local, and Tribal Governments 56 5 0

2011-05-02-04:00

0938-1129 201101-0938-002 0938
             
        "Appeals of Quality Bonus Payment Determinations"
             
          
        
Section 1853(o) of the Social Security Act requires us to make Quality Bonus Payments (QBPs) to Medicare Advantage (MA) organizations that achieve performance rating scores of at least 4 stars under a five star rating system. Beginning in 2012, the star ratings we assign for purposes of QBPs under section 1858(o) of the Act will directly affect the monthly payment amount MA organizations receive from us under their contracts. In effect, this information collection request addresses a review process through which MA organizations may seek review of determinations governing their star rating ("QBP status") when the MA organization's rating is less than 4 stars. Regarding the appeals process, MA organizations have 5 calendar days from the date of CMS' release of its QBP determinations to request a technical report from CMS explaining the development of their QBP status. The technical report will be provided in writing by electronic mail to the MA organization and CMS within 30 days of CMS' receipt of the organization's request for the report by the technical report contractor. If, after reviewing the technical report, the MA organization believes that CMS was incorrect in its QBP determination, within 7 calendar days, the MA organization may request an appeal to be conducted by a hearing officer designated by CMS. The hearing officer's decision would be final and binding on both the MA organization and CMS. The hearing officer will be required to issue his/her decision on or before May 15 of the year preceding the year in which the plans for which the QBP is to be applied will be offered. 2014-05-31-04:00 Active Bonnie Harkless 4107865666 No Yes No 25 200 0

Appeals of Quality Bonus Payment Determinations (CMS-10346) No Health Health Care Services Private Sector 25 200 0

2011-05-06-04:00

0938-1133 201102-0938-005 0938
             
        " Disclosure Requirement for the In-Office Ancillary Services Exception "
             
          
        
n order to implement section 6003 of the Affordable Care Act, CMS has proposed to amend 42 C.F.R. 411.355(b). Section 6003 establishes a new disclosure requirement for physicians who refer magnetic resonance imaging, computed tomography, and positron emission tomography (MRI, CT and PET) under the in-office ancillary services exception to the prohibition on physician self-referral (section 1877 of the Social Security Act). Under this new requirement physicians must inform patients in writing, at the time of the referral, that the patient may receive the imaging service from another supplier. The physician must also provide the patient with a list of other suppliers that from whom the patient may obtain the services. The proposed rule provides detail regarding what criteria must be included in the disclosure notifcation and supplier list in order to satisfy this new requirement. 2014-06-30-04:00 Active William Parham 4107864669 No Yes No 7616760 196383 0

Development of Form No Health Health Care Services Private Sector 71000 71000 0

Disclosure Requirement No Health Health Care Services Private Sector 7545760 125383 0

2011-06-01-04:00

0938-1135 201206-0938-005 0938
             
        "Medicare Registration Application"
             
          
        
The publication of the Patient Protection and Affordable Care Act (PPACA), section 6405 - "Physicians Who Order Items or Services Required to be Medicare Enrolled Physicians or Eligible Professionals" (regulation CMS 6010-F), contains a requirement for certain physicians and non-physician practitioners to enroll in the Medicare program for the sole purpose of ordering or referring items or services for Medicare beneficiaries. The PPACA has an effective date applicable to written orders and certifications made on or after July 1, 2010. The CMS 855O allows a physician to receive a Medicare identification number (without being approved for billing privileges) for the sole purpose of ordering and referring Medicare beneficiaries to Medicare approved providers and suppliers. This new Medicare application form allows physicians who do not provide services to Medicare beneficiaries to be given a Medicare identification number without having to supply all the data required for the submission of Medicare claims. It also allows the Medicare program to identify ordering and referring physicians without having to validate the amount of data necessary to determine claims payment eligibility (such as banking information), while continuing to identify the physician's credentials as valid for ordering and referring purposes. 2015-08-31-04:00 Active William Parham 4107864669 No No No 48500 24125 0

Initial Application No Health Health Care Services
CMS-855O Medicare Registration Application Yes No Fillable Fileable Form and instruction CMS-855O_Draft_Form.pdf Yes Yes Fillable Fileable Other CMS-855O.Screenshots.docx
Private Sector 40000 20000 0

Change of Registration Information No Health Health Care Services
CMS-855O Medicare Registration Application Yes No Fillable Fileable Form and instruction CMS-855O_Draft_Form.pdf Yes Yes Fillable Fileable Other CMS-855O.Screenshots.docx
Private Sector 8000 4000 0

Reporting Voluntary Withdrawal of Registration Information No Health Health Care Services
CMS-855O Medicare Registration Application Yes No Fillable Fileable Form and instruction CMS-855O_Draft_Form.pdf Yes Yes Fillable Fileable Other CMS-855O.Screenshots.docx
Private Sector 500 125 0

2012-08-08-04:00

0938-1136 201106-0938-002 0938
             
        "Provider-Preventable Conditions under 42 CFR 438.6 and 447.26 and Title 2702 Non-Payment Preprint (Attachment 4.19)"
             
          
        
These collections are required because they will allow States to know when provider payment penalty is warranted as a result of a provider preventable condition (PPC). The collection will also allow CMS to ensure that States are not making payments to providers for PPCs. In CMS-2400-F (published June 1, 2011), section 438.6(f)(2) will require States which provide medical assistance using a managed care delivery system to modify their managed care contracts to reflect the PPCs payment adjustment policies as applied through these regulations. Section 447.26(c)(1) will require States to submit SPAs for CMS approval that would reduce payments to providers by amounts related to PPCs. The burden associated with this requirement will be the time and effort necessary for a State to submit its SPA and an associated pre-print. Section 447.26(c)(2) will also require States to implement provider reporting requirements to ensure that PPCs are identified in claims for Medicaid payment. 2014-07-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 158 2089 0

Provider-Preventable Conditions under 42 CFR 438.6(f)(2) No Health Health Care Services State, Local, and Tribal Governments 48 384 0

Provider-Preventable Conditions under 447.26(c)(1) and Payment for Services Preprint No Health Health Care Services State, Local, and Tribal Governments 55 385 0

Provider-Preventable Conditions under 42 CFR 447.26(c)(2) No Health Health Care Services State, Local, and Tribal Governments 55 1320 0

2011-07-07-04:00

0938-1137 201103-0938-001 0938
             
        "Letter Requesting Waiver of Medicare/Medicaid Enrollment Application Fee; Submission of Fingerprints; Submission of Medicaid Identifying Information; Medicaid Site Visit and Rescreening"
             
          
        
On March 23, 2010, the President signed into law H.R. 3590, the Patient Protection and Affordable Care Act (Affordable Care Act), Public Law 111-148. Section 6401 of the law establishes a number of important payment safeguard provisions, several of which have been incorporated into CMS Proposed Rule 6028, entitled "Medicare, Medicaid, and Children's Health Insurance Programs (CHIP); Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers," and published in the Federal Register on September 23, 2010. The provisions are designed to improve the integrity of the Medicare, Medicaid, and CHIP programs so as to reduce fraud, waste and abuse. 2014-07-31-04:00 Active William Parham 4107864669 No Yes No 960981 1248082 0

Medicare Enrollment Application Fee Waiver Request No Health Health Care Services Private Sector 12000 12000 0

Fingerprints - Medicare No Health Health Care Services Private Sector 45500 91000 0

Fingerprints - Medicaid No Health Health Care Services State, Local, and Tribal Governments 26000 52000 0

Collection of SSN and DOBs No Health Health Care Services State, Local, and Tribal Governments 427264 14242 0

Site Visits No Health Health Care Services State, Local, and Tribal Governments 5000 40000 0

Provider Rescreening No Health Health Care Services State, Local, and Tribal Governments 371014 742028 0

State Medicaid Agency Processing of Rescreening Application No Health Health Care Services State, Local, and Tribal Governments 74203 296812 0

2011-07-20-04:00

0938-1139 201201-0938-001 0938
             
        " Consumer Operated and Oriented Plan [CO-OP] Program"
             
          
        
The data collection in this package includes requirements associated with the Consumer Operated and Oriented Plan [CO-OP] Program, which includes Loan applications; Reconsideration requests and appeals; Loan Agreement acceptance and execution; Milestone updates; Financial reports; Progress reports; Enhanced financial and progress reports; Audits; and Recordkeeping. 2015-06-30-04:00 Active William Parham 4107864669 No Yes No 883 36111 0

Start-up & Solvency Loan Application No Health Health Care Services
CMS-10392 CO-OP FOA Yes Yes Fillable Fileable Form and instruction CMS-10392.CO-OP FOA (12-9-11).pdf
Private Sector 27 13932 0

Reconsiderations & Appeals No Health Health Care Services
CMS-10392 CO-OP FOA Yes Yes Fillable Fileable Form and instruction CMS-10392.CO-OP FOA (12-9-11).pdf
Private Sector 3 45 0

Loan Agreement Acceptance No Health Health Care Services
CMS-10392 CO-OP FOA Yes Yes Fillable Fileable Form and instruction CMS-10392.CO-OP FOA (12-9-11).pdf
Private Sector 51 816 0

Standard Reporting Before Loan Repayment - Start-up/Solvency Loan(s) Recipients No Health Health Care Services
CMS-10392 CO-OP FOA Yes Yes Fillable Fileable Form and instruction CMS-10392.CO-OP FOA (12-9-11).pdf CMS-10392 Reporting Templates Yes Yes Fillable Fileable Form and instruction CMS-10392.CO-OP Reporting Template.docx
Private Sector 612 11628 0

Standard Reporting After Loan Repayment - Start-up/Solvency Loan Recipients No Health Health Care Services
CMS-10392 Reporting Templates Yes Yes Fillable Fileable Form and instruction CMS-10392.CO-OP Reporting Template.docx CMS-10392 CO-OP FOA Yes Yes Fillable Fileable Form and instruction CMS-10392.CO-OP FOA (12-9-11).pdf
Private Sector 77 1530 0

Enhanced Reporting (Before Loan Repayment) - Start-up/Solvency Loan Recipients No Health Health Care Services
CMS-10392 Deliberative Document Yes Yes Fillable Fileable Form and instruction CMS-10392.Deliberative Document.docx CMS-10392 Reporting Templates Yes Yes Fillable Fileable Form and instruction CMS-10392.CO-OP Reporting Template.docx CMS-10392 CO-OP FOA Yes Yes Fillable Fileable Form and instruction CMS-10392.CO-OP FOA (12-9-11).pdf
Private Sector 20 60 0

Audits No Health Health Care Services
CMS-10392 CO-OP FOA Yes Yes Fillable Fileable Form and instruction CMS-10392.CO-OP FOA (12-9-11).pdf
Private Sector 42 5040 0

Recordkeeping No Health Health Care Services
CMS-10392 CO-OP FOA Yes Yes Fillable Fileable Form and instruction CMS-10392.CO-OP FOA (12-9-11).pdf
Private Sector 51 3060 0

2012-06-19-04:00

0938-1140 201310-0938-013 0938
             
        "Skilled Nursing Facility (SNF) Minimum Data Set (MDS) 3.0 Nursing Home and Swing Bed Prospective Payment System (PPS) Item Sets (NP, NO/SO, NS, NOD, NSD)"
             
          
        
Skilled Nursing Facilities (SNFs) will be required to submit a Change of Therapy (COT) Other Medicare Required Assessment (OMRA) to administer the payment rate methodology. This additional assessment is subject to the Paperwork Reduction Act. The burden associated with this is the SNF staff time required to complete the COT OMRA for the Minimum Data Set (MDS), SNF staff time to encode, and SNF staff time spent in transmitting the data. 2015-01-31-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 6396416 6608971 0

Skilled Nursing Facility (SNF) Minimum Data Set (MDS) 3.0 Nursing Home and Swing Bed Prospective Payment System (PPS) Item Sets (NP, NO/SO, NS, NOD, NSD) No Health Health Care Services
CMS-10387 Nursing Home OMRA-Start of Therapy and Discharge (NSD) Item Set Yes Yes Fillable Printable Form and instruction MDS3 0_NSD_OMRA-SOT-Dschg_v1 11 1.pdf CMS-10387 Nursing Home PPS (NP) Item Set Yes Yes Fillable Printable Form and instruction MDS3 0_NP_PPS_v1 11 1.pdf CMS-10387 Nursing Home and Swing Bed OMRA-Start of Therapy (NS/SS) Item Set Yes Yes Fillable Printable Form and instruction MDS3 0_NS_SS_OMRA-SOT_v1 11 1.pdf CMS-10387 Nursing Home OMRA-Discharge (NOD) Item Set Yes Yes Fillable Printable Form and instruction MDS3 0_NOD_OMRA-Other-Dschg_v1 11 1.pdf CMS-10387 Nursing Home and Swing Bed OMRA (NO/SO) Item Set Yes Yes Fillable Printable Form and instruction MDS3 0_NO_SO_OMRA-Other_v1 11 1.pdf
Private Sector 6396416 6608971 0

2014-01-15-05:00

0938-1142 201107-0938-011 0938
             
        "Autism Spectrum Disorders (ASD): State of the States in Services and Supports for People with ASD"
             
          
        
The Centers for Medicare & Medicaid Services (CMS) requests clearance for its primary contractor, L&M Policy Research (L&M) and partners, Thomson Reuters, and the National Association of State Directors of Developmental Disabilities Services (NASDDDS) to address the growing need among Federal and State policymakers and stakeholders for accurate and comprehensive information regarding available services and supports for people with ASD. The approach to gather this information in all 50 states and the District of Columbia will be to use a semi-structured interview guide that focuses on current services for people with ASD, policies for people with ASD and funding and utilization of public supports for people with ASD. 2014-09-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 153 268 0

State of the States in Services and Supports for ASD: Data Collection and Verification Tool No Health Health Care Services State, Local, and Tribal Governments 153 268 0

2011-09-05-04:00

0938-1143 201107-0938-003 0938
             
        "Consumer Research on Public Reporting of Hospital Quality Measures  (CMS-10360)"
             
          
        
This PRA package covers consumer research on displays, labels, and explanatory language to insure that the website is understood by viewers in a manner consistent with CMS;s intended communication message. 2014-09-30-04:00 Active William Parham 4107864669 No No No 140 187 0

Inital Screening Round 2 (Cognitive Interviews) No Health Health Care Services
CMS-10360 ED throughput Yes No Fillable Fileable Form ED throughput.pdf CMS-10360 HAI_HAC_MockUps Yes No Fillable Fileable Form HAI_HAC_MockUps.pdf CMS-10360 Screener_Informal Family Caregivers Yes Yes Fillable Fileable Form and instruction Screener_Informal Family Caregivers.pdf Yes No Fillable Fileable Instruction Mini Part A for first IC_061711.pdf CMS-10360 Consent Form Yes No Fillable Fileable Form and instruction Consent Form.pdf CMS-10360 Screener_Healthcare Patient Consumers Yes Yes Fillable Fileable Form and instruction Screener_Healthcare Patient Consumers.pdf
Individuals or Households 40 3 0

Interviews No Health Health Care Services
CMS-10360 ED throughput Yes No Fillable Fileable Form ED throughput.pdf CMS-10360 Screener_Physicians Yes No Fillable Fileable Form Screener_Physicians.pdf CMS-10360 HAI_HAC_MockUps Yes No Fillable Fileable Form HAI_HAC_MockUps.pdf CMS-10360 Intensive Interview Guide_Physicians_ HAC_HAI_ED Yes No Fillable Fileable Form Intensive Interview Guide_Physicians_ HAC_HAI_ED_6_20.pdf CMS-10360 Consent Form Yes No Fillable Fileable Form Consent Form.pdf
Private Sector 18 4 0

Consumer Research on Public Reporting of Hospital Quality Measures (IC's 3 and 4) No Health Health Care Services
CMS-10360 Consent Form Yes No Fillable Fileable Form Consent Form.pdf CMS-10360 HC Formative Testing Handout 3_ Yes No Fillable Fileable Form HC Formative Testing Handout 3_11_15_11.pdf CMS-10360 Screener_Healthcare Patient Consumers Yes No Fillable Fileable Form Screener_Healthcare Patient Consumers.pdf CMS-10360 Screener_Informal Family Caregivers Yes No Fillable Fileable Form Screener_Informal Family Caregivers.pdf CMS-10360 HC Formative Focus Group Mod Guide Yes No Fillable Fileable Form HC Formative Focus Group Mod Guide_11_15_11.pdf CMS-10360 HC Formative Testing Handout Yes No Fillable Fileable Form HC Formative Testing Handout 1_11_15_11.pdf CMS-10360 HC Formative Testing Handout 2 Yes No Fillable Fileable Form HC Formative Testing Handout 2_11_15_11.pdf
Private Sector 60 66 0

2011-09-05-04:00

0938-1144 201112-0938-006 0938
             
        "Application to Be a Qualified Entity to Receive Medicare Data for Performance Measurement"
             
          
        
Section 10332 of the Patient Protection and Affordable Care Act (ACA) requires the Secretary to make standardized extracts of Medicare claims data under Parts A, B, and D available to ''qualified entities'' for the evaluation of the performance of providers of services and suppliers. The statute provides the Secretary with discretion to establish criteria to determine whether an entity is qualified to use claims data to evaluate the performance of providers of services and suppliers. We are proposing at section CFR 401.703 to evaluate an organization's eligibility across three areas: organizational and governance capabilities, addition of claims data from other sources (as required in the statute), and data privacy and security. This is the application through which organizations will provide information to CMS to determine whether they will be approved as a qualified entity. 2015-04-30-04:00 Active William Parham 4107864669 No Yes No 35 6833 0

Application and Re-application processes No Health Health Care Services
Yes Yes Printable Only Instruction CMS-10394.QECP Operations Manual.pdf CMS-10394 Application for Qualified Entity Certification Yes Yes Fillable Fileable Form and instruction CMS-10394.QE Application (1-19-12).docx
Private Sector 35 6833 0

Re-application No Health Health Care Services
CMS-10394 Revised QE Application Yes No Fillable Fileable Form and instruction CMS-10394.REVISED QE Application(8-8-11).docx CMS-10392 Qualified Entity Application Yes No Fillable Fileable Form and instruction CMS-10394.Draft_QE_Application.pdf
Private Sector 0 0 0

2012-04-24-04:00

0938-1145 201111-0938-012 0938
             
        "State Balancing Incentive Payments Program (BIPP)"
             
          
        
The Centers for Medicare & Medicaid Services work in partnership with States to implement Medicaid and the Children's Health Insurance Program (CHIP). Together, these programs provide health coverage for millions of Americans. Medicaid and CHIP are based in Federal statute, associated regulations and policy guidance, and the approvedState plan documents that serve as a contract between CMS and States about how Medicaid and CHIP will be operated in that State. When modifications or enhancements to the program are prescribed by Congress through legislation, each State's programs must be amended to comply. For example, in March 2010, Congress passed the Affordable Care Act, which enacted comprehensive reform of the Medicaid program. The Balancing Incentive Program was enacted as Section 10202 of that Act, and provides States an opportunity to balance their expenditures on long-term services and supports by incentivizing the increase of community versus institutional services. 2015-01-31-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 56 2240 0

State Balancing Incentive Payments Program (BIPP) Application No Health Health Care Services
CMS-10411 State Balancing Incentive Payments Program (BIPP) Application Yes Yes Printable Only Form and instruction BIPP App_Clean_083111 [rev 11-29-11].doc
State, Local, and Tribal Governments 56 2240 0

2012-01-03-05:00

0938-1146 201304-0938-007 0938
             
        "Summary of Benefits and Coverage and Uniform Glossary"
             
          
        
The Patient Protection and Affordable Care Act, Pub. L. 111-148, was signed into law on March 23, 2010, and the Health Care and Education Reconciliation Act of 2010, Pub. L. 111-152, was signed into law on March 30, 2010 (these are collectively known as the "Affordable Care Act"). The Affordable Care Act amends the Public Health Service Act (PHS Act) by adding section 2715 "Development and Utilization of Uniform Explanation of Coverage Documents and Standardized Definitions." Section 2715 directs the Secretary, in consultation with the National Association of Insurance Commissioners and a working group comprised of stakeholders, to develop standards for use by a group health plan and a health insurance issuer in compiling and providing to applicants, enrollees, and policyholders and certificate holders a summary of benefits and coverage (SBC) that accurately describes the benefits and coverage under the applicable plan or coverage. Section 2715 also directs the Secretary to provide for the development of standards for the defintions of terms used in health insuance. Finally, section 2715 requires 60-days advance notice of any material modification in any of the terms of the plan or coverage that is not reflected in the most recently provided SBC. To implement these disclosure requirements, the final rule would require a collection of information by health insurance issuers in the group and individual markets and third-party administrators. Collection of information requirements relate to the provision of the following: 1. Summary of benefits and coverage (SBC) 2. Coverage examples (as a component of each SBC) 3. A uniform glossary of health coverage and medical terms (uniform glossary) 4. Notice of modifications 2015-02-28-05:00 Active William Parham 4107864669 No Yes No 13058000 300220 1300000

SBC disclosure No Health Health Care Services
CMS-10407 Summary_of_Benefit_and_Coverage_Template (4-25-13) Yes Yes Fillable Fileable Form and instruction Revised Summary_of_Benefit_and_Coverage_Template (4-25-13).doc CMS-10407 Appendix A Yes Yes Fillable Fileable Form and instruction Appendix_A_ SBC PlanFinder New Benefit Template.pdf Yes No Printable Only Instruction Why This Matters - Yes Answers 2-7-12 clean.doc Yes No Printable Only Instruction Why This Matters - No Answers 2-7-12 clean.doc CMS-10407 Uniform Glossary Yes Yes Fillable Fileable Form and instruction Uniform Glossary 2-7-12 clean.doc CMS-10407 Sample Completed SBC Yes Yes Fillable Fileable Form and instruction Sample Completed SBC 2-7-12 clean.doc CMS-10407 Maternity_Narrative Yes Yes Fillable Fileable Form and instruction Maternity_Narrative_2-7-12.docx CMS-10407 Instructions Individual Yes Yes Fillable Fileable Form and instruction Instructions Individual 2-7-12 clean.docx CMS-10407 Instructions Group Yes Yes Fillable Fileable Form and instruction Instructions Group 2-7-12 clean.docx CMS-10407 Diabetes_Scenario Yes Yes Fillable Fileable Form and instruction Diabetes_Scenario_2-7-12.xlsx CMS-10407 Diabetes_Narrative Yes Yes Fillable Fileable Form and instruction Diabetes_Narrative_2-7-12.doc CMS-10407 Maternity Scenario Yes Yes Fillable Fileable Form and instruction Maternity Scenario 2-7-12.xlsx
Private Sector 13000000 300000 1300000

Deemed Compliance Reporting No Health Health Care Services
CMS-10407 Deliberative Document Yes No Fillable Fileable Form and instruction CMS-10407.Deliberative Document.docx
Private Sector 58000 220 0

2013-05-03-04:00

0938-1147 201203-0938-012 0938
             
        "Medicaid Program; Eligibility Changes under the Affordable Care Act of 2010"
             
          
        
The Patient Protection and Affordable Care Act (Pub. L. 111-148, enacted on March 23, 2010) as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152, enacted on March 30, 2010) are collectively referred to as the Affordable Care Act. The Affordable Care Act expands access to insurance affordability programs through improvements in Medicaid eligibility, enrollment simplification, the establishment of Affordable Insurance Exchanges ("Exchanges"), and coordination between Medicaid, the Children's Health Insurance Program (CHIP), and Exchanges. Relevant to this Statement, the Affordable Care Act promotes a high level of coordination, simplification, and data sharing among State and Federal agencies for the purpose of a seamless and streamlined eligibility system. The Affordable Care Act allows for significant use of Web-based technology to provide information to the public and facilitate application and renewal functions. It creates a "no wrong door" approach to insurance affordability programs so that individuals will not have to apply to multiple programs. Nor will they have to repeat the application process if they initially apply to a program for which they are not ultimately determined eligible. It also provides a simplified process for maintaining coverage through a streamlined renewal process. The provisions of the Affordable Care Act relevant to this Statement are effective January 1, 2014. The proposed requirements for the collection and reporting of information and recordkeeping (collectively known as information collections) generally relate to ensuring data sharing and coordination among State and Federal agencies, recordkeeping efforts among State agencies, and the development of Web-based systems and notices in support of the implementation of the Affordable Care Act. 2015-07-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 76500149 21278142 0

Eligibility Verification (42 CFR 435.945, 435.948, 435.956, 457.350, and 457.380) No Health Health Care Services State, Local, and Tribal Governments 0 0 0

Periodic Renewal of Medicaid and CHIP Eligibility - Eligibility Notice (sections 435.916, 457.343, and 457.350) No Health Health Care Services State, Local, and Tribal Governments 96 1536 0

Periodic Renewal of Medicaid and CHIP Eligibility - Pre-Populated Renewal Form (sections 435.916, 457.343, and 457.350) No Health Health Care Services Individuals or Households 25500000 8500000 0

Web Sites (sections 435.1200 and 457.335) No Health Health Care Services State, Local, and Tribal Governments 53 26606 0

Periodic Renewal of Medicaid and CHIP Eligibility - Recordkeeping (sections 435.916, 457.343, and 457.350) No Health Health Care Services State, Local, and Tribal Governments 51000000 12750000 0

2012-07-26-04:00

0938-1148 201111-0938-009 0938
             
        "Generic Clearance for Medicaid and CHIP State Plan, Waiver, and Program Submissions"
             
          
        
The Center for Medicaid, CHIP, and Survey & Certification in CMS works in partnership with States to implement Medicaid and the Children's Health Insurance Program (CHIP), and the Social Security Act requires written plans between CMS and the State to implement these programs. The Affordable Care Act enacted comprehensive reform that requires modification of existing programs. In addition to the Medicaid and CHIP State plans, CMS also continues to work with States through other methods to further the goals of health reform, including program waivers and demonstrations and other technical assistance initiatives and reporting. This collection will provide streamlined submission forms for States to implement health reform initiatives in Medicaid and CHIP state plans, demonstrations, and waivers, including legislative requirements enacted by the Affordable Care Act. 2014-10-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 3360 86240 0

CHIP Annual Report Template System (CARTs) No Health Health Care Services
CMS-10398-001 CHIP Annual Report Template System (CARTs) Yes Yes Fillable Printable Form CARTS Template [rev 12-19-11].doc CMS-10398-003 Medicaid Recovery Audit Contractor (RAC) Program Yes Yes Fillable Printable Form Phase II Mockup_approved clean_11-15-11.docx CMS-10398-002 2011 Medicaid Managed Care Enrollment Data Dictionary Yes Yes Printable Only Form and instruction Att 2-2011ERDDf.docx CMS-10398-002 2011 National Summary Data Dictionary Yes Yes Printable Only Form and instruction Att 1-NSDD2011f.docx
State, Local, and Tribal Governments 168 5600 0

Bundle: (GenIC 1) Medicaid Buy In, (GenIC 2) CNIPRA Cycle II, and (GenIC 3) PIE Transaction No Health Health Care Services
CMS-10398-008 Payer Initiated Eligibility/Benefit (PIE) Transaction - DRA Companion Guide Yes Yes Fillable Printable Form and instruction PIE - Attachment A PIE Transaction Companion Guide- June 2010 (2).pdf Yes No Fillable Printable Instruction PIE - Attachment C SMD10011 (2).pdf CMS-10398-006 Medicaid Buy-In Program: 2010 Policy Update Yes Yes Fillable Printable Form and instruction Medicaid Buy In Program [rev 04-11-2012 OSORA].docx CMS-10398-007 CHIPRA Cycle II - Outreach and Enrollment Grant Semi-Annual Report Template Yes Yes Fillable Printable Form and instruction CHIPRA Cycle II Semi-Annual Template_Final Draft for PRA [rev 04-11-2012 OSORA].doc Yes No Fillable Printable Instruction PIE - Attachment B Companion Guide - Business Scenarios (2).pdf
State, Local, and Tribal Governments 169 3380 0

Bundle: (GenIC 1) Sec. 1915(b)(4) Waiver Application - Fee For Service Selective Contracting Program & (GenIC 2) Sec. 1115 Demo and Waiver Application No Health Health Care Services
Yes No Fillable Printable Other List of Eligibility Groups.docm Yes No Fillable Printable Other List of Medicaid and CHIP Benefits.docm CMS-10398-10 Demonstration Financing Form Yes Yes Fillable Printable Form and instruction Demo Financing Form.docm CMS-10398-10 Budget Neutrality Form Yes Yes Fillable Printable Form and instruction Budget Neutrality Form_ 6 29 2012.docm CMS-10398-10 Long Term Services Benefit Specifications and Provider Qualifications Yes Yes Fillable Printable Form Long Term Services Benefit Specifications and Provider Qualifications.docx CMS-10398-10 Benefit Specifications and Provider Qualifications Yes Yes Fillable Printable Form Benefit Specifications and Provider Qualifications.docx Yes No Printable Only Other Information on Cost Sharing Requirements.docx CMS-10398-10 List of Frequently Requested Waivers and Expenditure Authorities Yes Yes Fillable Printable Form List of Waivers and Expenditure Authorities_ 6 28 12.docm CMS-10398-009 Application for Section 1915(b)(4) Waiver - Fee For Service Selective Contracting Program Yes Yes Fillable Printable Form and instruction 1915b(4) FFS preprint Template [rev 07-11-2012 by OSORA PRA].doc CMS-10398-10 1115 Demonstration Application Budget Neutrality Table Shell Yes Yes Fillable Fileable Form Interim Section 1115 Demonstration Application BN Table Shell v2.xlsx CMS-10398-10 Long Term Services and Supports Form Yes Yes Fillable Printable Form List of LTSS Benefits.docm Yes No Fillable Printable Instruction New Demo App Template [rev 07-11-2012 by OSORA PRA].docx
State, Local, and Tribal Governments 112 4480 0

Bundle: (GenIC 1) MAGI-based Eligibility Verification Plan and (GenIC 2) Increase in Primary Care Services Payments No Health Health Care Services
CMS-10398 #12 Reimbursement Template - Physician Services (Attachment 4.19-B) Yes Yes Fillable Printable Form Combined Primary Care Bump and VFC SPA Template.docx CMS-10398 #11 MAGI-based Eligibility Verification Plan Yes Yes Fillable Printable Form and instruction Verification_Plan_Template.docx
State, Local, and Tribal Governments 107 4688 0

Reimbursement Template -Physician Services Increased Primary Care Service Payment 42 CFR 447.405, 447.410, 447.415 No Health Health Care Services State, Local, and Tribal Governments 1 0 0

Medicaid Accountability - Nursing Facility, Outpatient Hospital and Inpatient Hospital Upper Payment Limits No Health Health Care Services
CMS-10398 (13) Outpatient Hospital UPL Guidance Yes Yes Fillable Printable Form Outpatient Hospital UPL Guidance final.docx Yes No Printable Only Instruction IP_instructions_final_REVISED.docx Yes No Fillable Printable Instruction OP_instructions final.docx CMS-10398 (13) Nursing Facility UPL Guidance Yes Yes Fillable Fileable Form Nursing Facility UPL Guidance final.docx Yes No Fillable Printable Instruction NF instructions final.docx CMS-10398 (13) Inpatient Hospital UPL Guidance Yes Yes Fillable Printable Form Inpatient Hospital UPL Guidance final.docx
State, Local, and Tribal Governments 56 2240 0

MAGI Conversion Plan (Information Collection #14 ) No Health Health Care Services
CMS-10398 (#14) 14 MAGI Conversion Plan Yes Yes Fillable Printable Form and instruction MAGI Income Conversion Plan revised_4_3 [rev 4-5-13 by OSORA PRA].docx
State, Local, and Tribal Governments 56 1120 0

Collection # 16: Federally-Facilitated Marketplace Integration Data Collection Tool No Health Health Care Services
CMS-10398 Federally Facilitated Marketplace and State Based Rules Integration Plan (CHIP) Yes Yes Fillable Printable Form FFM and State Based Rules Integration Charts.xlsx
State, Local, and Tribal Governments 56 1120 0

Collection #15 Medicaid State Plan Eligibility No Health Health Care Services
CMS-10398 S50 Yes Yes Fillable Fileable Form S50.pdf CMS-10398 S33 Yes Yes Fillable Fileable Form S33.pdf CMS-10398 S32 Yes Yes Fillable Fileable Form S32.pdf CMS-10398 S30 Yes Yes Fillable Fileable Form S30.pdf CMS-10398 S28 Yes Yes Fillable Fileable Form S28.pdf CMS-10398 S25 Yes Yes Fillable Fileable Form S25.pdf CMS-10398 S21 Yes Yes Fillable Fileable Form S21.pdf CMS-10398 S14 Yes Yes Fillable Fileable Form S14.pdf CMS-10398 S10 Yes Yes Fillable Fileable Form S10.pdf CMS-10398 A1-A3 Yes Yes Fillable Fileable Form A1-A3.pdf CMS-10398 S94 Yes Yes Fillable Fileable Form S94.pdf CMS-10398 S89 Yes Yes Fillable Fileable Form S89.pdf CMS-10398 S88 Yes Yes Fillable Fileable Form S88.pdf CMS-10398 S59 Yes Yes Fillable Fileable Form S59.pdf CMS-10398 S53 Yes Yes Fillable Fileable Form S53.pdf CMS-10398 S54 Yes Yes Fillable Fileable Form S54.pdf CMS-10398 S55 Yes Yes Fillable Fileable Form S55.pdf CMS-10398 S57 Yes Yes Fillable Fileable Form S57.pdf CMS-10398 S52 Yes Yes Fillable Fileable Form S52.pdf CMS-10398 S51 Yes Yes Fillable Fileable Form S51.pdf
State, Local, and Tribal Governments 56 1120 0

CHIP State Plan Eligibility (ICR #17) No Health Health Care Services State, Local, and Tribal Governments 56 2800 0

Information Collection #18: Alternative Benefit Plans No Health Health Care Services
CMS-10398 (#18) Mock-up of Interim Form for Alternative Benefit Plans Yes Yes Fillable Printable Form ABP MockUp_Final_7_2_13 [rev 7-3-2013 by OSORA PRA].docx
State, Local, and Tribal Governments 56 448 0

Eligibility and Enrollment Performance Indicators (Collection #19 ) No Health Health Care Services State, Local, and Tribal Governments 56 2240 0

Bundle (2 GenICs) - PERM Pilot (#20) and FMAP Claiming (#21) No Health Health Care Services
CMS-10398 (#21) Threshold Methodology for Identification of Applicable FMAP Rates Yes Yes Fillable Printable Form FMAP Claiming SPA 9-16-13-Attachments.docx Yes No Printable Only Instruction FMAP Claiming SPA Instructions.docx CMS-10398 (#20) PERM Pilot Submission Template Yes Yes Fillable Printable Form PERM Pilot Proposal Submission State Template.xlsx
State, Local, and Tribal Governments 52 2240 0

Bundle 3 GenICs - Health Home SPA (#22), Primary Care Payment Increase (#23), and Medicaid Accountability (#24) No Health Health Care Services
Yes No Printable Only Instruction V - ACR Narrative Instructions Final Draft Clean.docx Yes No Printable Only Instruction IV - Clinic UPL Guidance final.docx Yes No Printable Only Instruction III - Clinic Instructions Final.doc Yes No Printable Only Instruction II - ICFID Guidance final.docx Yes No Printable Only Instruction I - ICFID instructions final.doc Yes Yes Fillable Printable Instruction Medicaid Primary Care Payment Increase - State Data Collection Tool 8-20-13.xls CMS-10398 (#22) Health Home State Plan Amendment Yes Yes Fillable Printable Form MMDLHealthHomesBlankTestState.pdf CMS-10398 (#22) Health Homes Administrative Component Yes Yes Fillable Printable Form MMDLHealthHomesAdminReportBlankTestState.pdf CMS-10398 (#23) Funding Questions Yes Yes Fillable Printable Form IX - Funding Questions.doc Yes No Printable Only Instruction VIII - Other Facility Guidance -Final.docx Yes No Printable Only Instruction VII - Other facility Instructions final.docx CMS-10398 (#23) ACR Supplemental Payment Demonstration Guidance Yes Yes Fillable Printable Form VI - 4 4 Phys Review Guidance Web Version Final Draft Clean.docx
State, Local, and Tribal Governments 160 6720 0

Bundle (2 GenICs) - Tobacco Cessation Quitline Expenditures (#25) and Medicaid Adult Core Set Measures Reporting Template (#26) No Health Health Care Services
CMS-10398 (#25) Tobacco Cessation Quitline Expenditures - Participation in Medicaid Administration Federal Financial Participation (FFP) Yes Yes Fillable Printable Form Tobacco Cessation Quitline Expenditures Collection template.docx CMS-10398 (#26) Medicaid Adult Core Set Measures Reporting Template in CARTS Yes Yes Fillable Printable Form and instruction Medicaid Adult Core Set Measures Reporting Template.docx
State, Local, and Tribal Governments 56 2352 0

MAGI Conversion Plan Part 2 (GenIC #27) No Health Health Care Services
CMS-10398 (#27) Part 2 of Modified Adjusted Gross Income (MAGI) Conversion Plan Yes Yes Fillable Printable Form and instruction Part 2 of Modified Adjusted Gross Income (MAGI) Conversion Plan.doc
State, Local, and Tribal Governments 56 1120 0

MMIS APD Template NCCI Coding Initiative (Information Collection #28) No Health Health Care Services
CMS-10398 (#28) Advance Planning Document (APD) Template for Implementation of the National Correct Coding Initiative (NCCI) in a State's Medicaid Management Information System (MMIS) Yes Yes Fillable Printable Form MedicaidNCCIAPDFinal 508 version [rev 1-30-2014 by OSORA PRA].pdf
State, Local, and Tribal Governments 280 840 0

2011-11-28-05:00

0938-1149 201303-0938-006 0938
             
        "Version 5010/ICD-10 Industry Readiness Assessment"
             
          
        
Findings from the ICD-10 industry readiness assessment will be used by CMS to understand each sector's progress toward compliance and to determine what communication and educational efforts can best help affected entities obtain the tools and resources they need to achieve timely compliance with ICD-10. Respondents to this information collection are health care providers, payers, and vendors. 2016-06-30-04:00 Active William Parham 4107864669 No No No 1200 204 0

Survey No Health Health Care Services
CMS-10381 Appendix D1 ICD 10 industry readiness assessment questionnaire Yes No Fillable Fileable Form and instruction CMS-10381.Appendix D1 ICD 10 industry readiness assessment questionnaire 2012 09 26.doc CMS-10381 CMS-10381.Appendix C Respondent Letters Version 5010 ICD10 Readiness Assessment Yes No Fillable Fileable Form CMS-10381.Appendix C Respondent Letters Version 5010 ICD10 Readiness Assessment.pdf CMS-10381 Appendix D2 ICD 10 readiness assessment questionnaire for post deadline fielding Yes No Fillable Fileable Form and instruction CMS-10381.Appendix D2 ICD 10 readiness assessment questionnaire for post deadline fielding 2012.09.26.docx
Private Sector 1200 204 0

2013-06-10-04:00

0938-1150 201301-0938-008 0938
             
        "Early Retiree Reinsurance Program: Survey of Plan Sponsors"
             
          
        
As part of the Secretary's monitoring efforts, the Secretary intends to direct plan sponsors that have received ERRP funds to respond to this survey in order to obtain information about the ERRP program, including how and when plan sponsors have used, or intend to use, ERRP funds. 2016-02-29-05:00 Active William Parham 4107864669 No Yes No 3003 33033 0

Survey of Plan Sponsors (Public Entities) No Health Health Care Services
CMS-10408 ERRP Survey of Plan Sponsors Yes Yes Fillable Fileable Form CMS 10408_ERRP Survey of Plan Sponsors_508.pdf Yes No Printable Only Instruction CMS 10408_ERRP Survey of Plan Sponsors_Instructions_508.pdf CMS-10408 REVISED ERRP Survey of Plan Sponsors 11-17-11 Yes Yes Fillable Fileable Form CMS-10408 REVISED ERRP Survey of Plan Sponsors 11-17-11 (2).docx Yes No Printable Only Instruction CMS-10408 REVISED _ ERRP Survey of Plan Sponsors _ Instructions 11-17-11.docx Yes No Printable Only Other CMS-10408 ERRP Survey_Email to Sponsors 11_17_11_FINAL.docx Yes No Printable Only Instruction CMS-10408.Final Draft Survey Instructions (11-23-11).pdf CMS-10408 Final Survey Yes No Fillable Printable Form CMS-10408.FINAL - Survey (11-28-11).pdf
Private Sector 1038 11418 0

Survey of Plan Sponsors (Private Entities) No Health Health Care Services
Yes No Printable Only Instruction CMS 10408_ERRP Survey of Plan Sponsors_Instructions_508.pdf CMS-10408 ERRP Survey of Plan Sponsors Yes Yes Fillable Fileable Form CMS 10408_ERRP Survey of Plan Sponsors_508.pdf Yes No Printable Only Instruction CMS-10408 REVISED _ ERRP Survey of Plan Sponsors _ Instructions 11-17-11.docx CMS-10408 REVISED ERRP Survey of Plan Sponsors 11-17-11 Yes Yes Fillable Fileable Form CMS-10408 REVISED ERRP Survey of Plan Sponsors 11-17-11 (2).docx Yes No Printable Only Other CMS-10408 ERRP Survey_Email to Sponsors 11_17_11_FINAL.docx Yes No Printable Only Instruction CMS-10408.Final Draft Survey Instructions (11-23-11).pdf CMS-10408 Final Survey Yes No Fillable Printable Form CMS-10408.FINAL - Survey (11-28-11).pdf
Private Sector 1038 11418 0

Survey of Plan Sponsors No Health Health Care Services
CMS-10408 Revised_Survey_Screenshots Yes Yes Fillable Fileable Form and instruction CMS-10408_Revised_Survey_Screenshots.pdf CMS-10408 ERRP Survey Yes Yes Fillable Fileable Form and instruction CMS-10408_ERRP_Revised_Survey_Clean_FINAL.pdf
Private Sector 927 10197 0

2013-02-07-05:00

0938-1151 201110-0938-004 0938
             
        "Medicaid Program; Medicaid State Plan Preprint for Use by States When Implementing Section 6401, Provider Screening and Other Enrollment Requirements Under Medicare, Medicaid and CHIP"
             
          
        
The Patient Protection and Affordable Care Act (Affordable Care Act) requires implementation of Section 6401, Provider Screening and Other Enrollment Requirements Under Medicare, Medicaid and CHIP. CMS will provide guidance to States on this provision and includes as an Enclosure, the Medicaid State Plan Preprint. Within this guidance, CMS states that the Medicaid State Plan Preprint is required for States to assure compliance to the Section 6401 provision. CMS has developed the Medicaid State Plan Preprint for Section 6401 for State convenience. 2014-12-31-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 56 14 0

Medicaid State Plan Preprint for Use by States When Implementing Section 6401, the Provider Screening and Other Enrollment Requirements Under Medicare, Medicaid and CHIP No Health Health Care Services
CMS-10402 Provider Screening and Enrollment Guidance Yes No Fillable Printable Form Provider Screening and Enrollment Guidance [rev 2011-29-11 at 5_00 pm].docx
State, Local, and Tribal Governments 56 14 0

2011-12-12-05:00

0938-1152 201110-0938-012 0938
             
        "Collection of Encounter Data from Medicare Advantage Organizations"
             
          
        
Given the increased importance of the accuracy of our Medicare Advantage risk adjustment methodology, we amended ? 422.310 in August of 2008 to announce that CMS would collect data from MA organizations regarding each item and service provided to an MA plan enrollee. This would allow CMS to incorporate the Medicare Advantage utilization in the development of risk adjustment models for the Medicare Advantage program. 2014-12-31-05:00 Active William Parham 4107864669 No No No 517793438 34520 0

Collection of Encounter Data from Medicare Advantage Organizations No Health Health Care Services Private Sector 517793438 34520 0

2011-12-30-05:00

0938-1153 201208-0938-005 0938
             
        "Hospice Quality Reporting Program"
             
          
        
Section 1814(i)(5) of the Act added by section 3004 of the Patient Protection and Affordable Care Act, Pub. L. 111 148, enacted on March 23, 2010 (Affordable Care Act), authorizes the Secretary to establish a quality reporting program for Hospices. Section 1814(i)(5)(A)(i) of the Social Security Act requires that the Secretary, beginning with FY 2014, reduce the market basket update by 2 percentage points for any hospice that does not submit quality data submission for a fiscal year. We are requesting approval, under the Paperwork Reduction Act of 1995, of a revised internet based, data submission form that hospice providers will use to submit quality measures data to CMS for the Hospice Quality Reporting Program (Hospice QRP). Use of this revised internet data submission form shall begin during the second Hospice QRP reporting period which shall take place from 10/01/2012 through 12/31/2012. Thereafter, the revised hospice data submission form shall be used for all subsequent data collection timeframes, which shall commence on January 1st and end on December 31st each year. To meet the quality reporting requirements which were set forth in the Hospice Wage Index Final Rule (76 F.R. Vol. 76, No. 150, August 4, 2011), hospices are to report quality data pertaining to two quality measures: (1) a structural measure titled "Participation in a Quality Assessment and Performance Improvement (QAPI) Program that Includes at Least Three Quality Indicators Related to Patient Care" and; (2) the NQF endorsed #0209 pain measure which is further described as: the percentage of patients who report being uncomfortable because of pain at the initial assessment (after admission to hospice services) who report pain was brought to a comfortable level within 48 hours. 2015-09-30-04:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No Yes No 3632 657392 0

Hospice Voluntary Quality Data Reporting Form No Health Health Care Services
CMS-10390 User Guide for Hospice Quality Reporting Data Entry Site Yes Yes Fillable Printable Form and instruction HospiceQualityReporting-UserGuide.pdf
Private Sector 0 0 0

Submission of Hospice Quality Reporting Program Quality Data using a web based data entry form No Health Health Care Services
CMS-10390 Hospice Data Submission Form Yes Yes Fillable Fileable Form and instruction Hospice QRP DataSubmissionForm_06-28-2012.pdf
Private Sector 3632 657392 0

2012-09-28-04:00

0938-1154 201110-0938-002 0938
             
        "Medication Therapy Management Program Improvements - Standardized Format"
             
          
        
The MMA of 2003 under title 42 CFR Part 423, Subpart D, established the requirements that Part D sponsors must meet with regard to medication therapy management (MTM) programs. Beginning in 2010, sponsors must offer an interactive, person-to-person comprehensive medication review (CMR) by a pharmacist or other qualified provider at least annually. A CMR is a review of a beneficiary's medications, including prescription and over-the-counter (OTC) medications, herbal therapies, and dietary supplements, which is intended to aid in assessing medication therapy and optimizing patient outcomes. Sponsors must summarize the CMR and provide an individualized written or printed summary to the beneficiary. The burden associated with the time and effort necessary for Part D sponsors to conduct CMRs with written summaries was estimated previously (RIN 0938-AP77, OCN: 0938-0964).The ACA under Section 10328 specifies that the Secretary, in consultation with relevant stakeholders, develop a standardized format for the action plan and written or printed summary that are given to beneficiaries as a result of their CMRs. The standardized format will replace whatever formats Part D sponsors are using for their written CMR summaries and action plans prior to 2013. Beginning in January, 2013, Part D sponsors will collect information required by the new standardized format, and provide that information to Medicare beneficiaries after their CMRs on forms that comply with the requirements specified by CMS for the standardized format (RIN 0938-AQ00). The use of the standardized format will support a uniform and consistent level of MTMP communications with beneficiaries, improve the ability of beneficiaries to understand and manage their medications safely and effectively, and support improved healthcare outcomes and lower overall healthcare costs. The final standardized format will be posted in the 2013 Call Letter for implementation by Part D sponsors in January 2013. 2015-01-31-05:00 Active William Parham 4107864669 No Yes No 1876346 1179894 1706250

Programming the standardized format No Health Health Care Services
CMS-10396 MEDICATION THERAPY MANAGEMENT PROGRAM STANDARDIZED FORMAT Yes No Fillable Fileable Form and instruction CMS-10396_MTMP_Standardized_Format.pdf
Private Sector 673 80760 0

Training MTM providers to use the standardized format No Health Health Care Services
CMS-10396 MEDICATION THERAPY MANAGEMENT PROGRAM STANDARDIZED FORMAT Yes No Fillable Fileable Form and instruction CMS-10396_MTMP_Standardized_Format.pdf
Private Sector 673 5384 0

Conducting CMRs with the standardized format and Fulfillment burden No Health Health Care Services
CMS-10396 MEDICATION THERAPY MANAGEMENT PROGRAM STANDARDIZED FORMAT Yes No Fillable Fileable Form and instruction CMS-10396_MTMP_Standardized_Format.pdf
Private Sector 1875000 1093750 1706250

2012-01-20-05:00

0938-1155 201309-0938-028 0938
             
        "Standards Related to Reinsurance, Risk Corridors, and Risk Adjustment"
             
          
        
The reinsurance program, risk corridors program, and risk adjustment program support the effective functioning of the American Health Benefit Exchanges ("Exchanges"), which will become operational by January 1, 2014. The program also mitigate the negative impacts of adverse selection and market uncertainty. 2016-12-31-05:00 Active William Parham 4107864669 No Yes No 568485 1075514 0

State Notice of Insurance Benefits and Payment Parameters (153.100-153.110) No Health Health Care Services State, Local, and Tribal Governments 75 8388 0

State Standards for the Transitional Reinsurance Program in the Individual Market (153.210-153.220, 153.240) - Recordkeeping No Health Health Care Services State, Local, and Tribal Governments 51 18972 0

State Standards for the Risk Adjustment Program (153.310, 153.330) - Request and Update for Alternative Methodology No Health Health Care Services State, Local, and Tribal Governments 5 190 0

Health Insurance Issuer Standards Related to the Transitional Reinsurance Program (153.400-153.410) No Health Health Care Services Private Sector 1827 21924 0

Health Insurance Issuer Standards for the Risk Adjustment Program (153.610-153.620) No Health Health Care Services Private Sector 1827 36540 0

Upload of Risk Adjustment and Reinsurance Data for Masked Enrollee Identification Number No Health Health Care Services Private Sector 1800 5400 0

Calculation of Reinsurance Contributions No Health Health Care Services Private Sector 22900 22900 0

Data Validation Requirements When HHS Operates Risk Adjustment No Health Health Care Services Private Sector 540000 961200 0

2013-12-02-05:00

0938-1156 201205-0938-010 0938
             
        "Establishment of Qualified Health Plans and American Health Benefit Exchanges"
             
          
        
The Patient Protection and Affordable Care Act, Public Law 111-148, enacted on March 23, 2010, and the Health Care and Education Reconciliation Act, Public Law 111-152, enacted on March 30, 2010 (collectively, "Affordable Care Act"), expand access to health insurance for individuals and employees of small businesses through the establishment of new Affordable Insurance Exchanges (Exchanges), including the Small Business Health Options Program (SHOP). The Exchanges, which will become operational by January 1, 2014, will enhance competition in the health insurance market, expand access to affordable health insurance for millions of Americans, and provide consumers with a place to easily compare and shop for health insurance coverage. The reporting requirements and data collection in the Exchange rule address Federal requirements that States must meet with respect to the establishment and operation of an Exchange; minimum requirements that health insurance issuers must meet with respect to participation in a State based or Federally-facilitated Exchange; and requirements that employers must meet with respect to participation in the SHOP and compliance with other provisions of the Affordable Care Act. The submission seeks OMB approval of the regulatory PRA requirements associated with 45 CFR parts 155, 156, and 157. 2016-03-31-04:00 Active William Parham 4107864669 No Yes No 21879 1232237 0

Issuers No Health Health Care Services Private Sector 20400 988253 0

Exchanges No Health Health Care Services State, Local, and Tribal Governments 1479 243984 0

General Functions of an Exchange (Website) No Health Health Care Services State, Local, and Tribal Governments 0 0 0

Exchange Functions in the Individual Market: Enrollment in Qualified Health Plans No Health Health Care Services State, Local, and Tribal Governments 0 0 0

Exchange Functions: Small Business Health Options Program (SHOP) No Health Health Care Services State, Local, and Tribal Governments 0 0 0

Exchange Function: Certification of Qualified Health Plans No Health Health Care Services State, Local, and Tribal Governments 0 0 0

Qualified Health Plan Minimum Certification Standards No Health Health Care Services State, Local, and Tribal Governments 0 0 0

2013-03-25-04:00

0938-1157 201309-0938-027 0938
             
        "Student Health Insurance Coverage"
             
          
        
Under the Student Health Insurance Final Rule, issuers of student health insurance are required to disclose to the student and any dependents in the insurance policy or certificate and any other written materials that the policy being issued does not meet all of the requirements under the Affordable Care Act. 2017-01-31-05:00 Active Jamaa Hill 301 492-4190 No Yes No 2250010 74925 0

Student Health Insurance Notice Requirement No Health Health Care Services Private Sector 2250010 74925 0

2014-01-27-05:00

0938-1159 201112-0938-009 0938
             
        "Section 1115 Demonstration: Long Term Services and Supports and Other Service Models for Individuals with Disabilities and Chronic Conditions"
             
          
        
This template is designed to facilitate interested States in designing and implementing an 1115 waiver to provide less costly, more integrated services to prevent or delay the need for nursing home care. 2015-02-28-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 11 448 0

Section 1115 Demonstration Application Template No Health Health Care Services
CMS-10412 Section 1115 Demonstration Application Template Yes Yes Fillable Printable Form and instruction Section 1115 Application Template [rev 12-15-11].docx
State, Local, and Tribal Governments 11 448 0

2012-02-22-05:00

0938-1160 201111-0938-010 0938
             
        "CMS National Balancing Indicators Project (NBIP) Direct Service Workforce (DSW) Data Collection Effort"
             
          
        
The Centers for Medicare and Medicaid Services (CMS) is requesting Office of Management and Budget (OMB) approval to conduct surveys of direct services workers and employer agencies to gather information about the home and community based direct service workforce in the seven CMS Real Choice Systems Change State Profile Tool (SPT) grantee states (Arkansas, Florida, Kentucky, Maine, Massachusetts, Michigan, and Minnesota). 2015-02-28-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 68160 57038 993217

Employer Organization Survey No Health Health Care Services
CMS-10404 Employer Organization Survey Yes Yes Fillable Fileable Form and instruction CMS-10404 - Employer Organization Surveys and Materials 2-14-12.docx
Private Sector 51560 51560 939423

Individual Worker Survey No Health Health Care Services
CMS-10404 Individual Worker Survey Yes Yes Fillable Printable Form and instruction CMS-10404 - Individual Worker Surveys and Materials 2-14-12 (2).doc
Individuals or Households 16600 5478 53794

2012-02-22-05:00

0938-1161 201306-0938-009 0938
             
        "Pre-Existing Condition Insurance Plan (PCIP) HIPAA Authorization Form"
             
          
        
Due to their health conditions, some PCIP applicants and enrollees require assistance from a third party when making inquiries to the PCIP program. Under the Health Insurance Portability and Accountability Act (HIPAA), the PCIP program may not disclose information about an applicant or enrollee to a third party without a valid authorization. The PCIP authorization form will allow a PCIP applicant or enrollee to designate an individual or organization to contact PCIP on behalf of the applicant or enrollee. This will make it easier for PCIP applicants and enrollees to obtain information and resolve issues regarding the application process, premium payments, claims status, and other matters. 2016-05-31-04:00 Active William Parham 4107864669 No Yes No 2100 525 0

PCIP Authorization Form No Health Health Care Services
CMS-10428 PCIP Authorization Form Yes No Fillable Fileable Form and instruction CMS-10428.PCIP Authorization.pdf
Individuals or Households 2100 525 0

2013-06-28-04:00

0938-1162 201202-0938-007 0938
             
        "Medicaid Program; Review and Approval Process for Section 1115 Demonstrations"
             
          
        
Section 10201(i) of the Affordable Care Act (ACA) added provisions under Section 1115 of the Social Security Act to require the Secretary to publish no later than 180 days after the enactment of this act, regulations that establish application requirements for demonstration projects. Under section 10201(i) of ACA the Secretary must establish a process for public notice and comment at the State level, and at the federal level after an application for a demonstration project is received by the Secretary. In addition, the Secretary must implement reporting requirements for States, establish a process for the periodic evaluation of demonstration projects and report annually to Congress on the implementation of previously approved demonstration projects. This collection would address the provisions required under Sections 10201(i) of the Affordable Care Act. 2015-03-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 130 13910 0

State Public Notice Process (431.408(a)(1)) No Health Health Care Services State, Local, and Tribal Governments 15 1200 0

Application Procedures (431.412(a) and (b)) No Health Health Care Services State, Local, and Tribal Governments 5 2000 0

State Public Notice Process (431.408(b)) No Health Health Care Services State, Local, and Tribal Governments 15 600 0

Application Procedures (431.412(c)) No Health Health Care Services State, Local, and Tribal Governments 10 3200 0

Monitoring and Compliance (431.420(b)) No Health Health Care Services State, Local, and Tribal Governments 15 1200 0

Evaluation Requirements (431.424(c)) No Health Health Care Services State, Local, and Tribal Governments 15 2400 0

Evaluation Requirements (431.424(d)) No Health Health Care Services State, Local, and Tribal Governments 10 1600 0

Evaluation Requirements (431.424(e)) No Health Health Care Services State, Local, and Tribal Governments 15 1050 0

Reporting Requirements (431.428(b)(2)) No Health Health Care Services State, Local, and Tribal Governments 15 60 0

Reporting Requirements (431.428(b)) No Health Health Care Services State, Local, and Tribal Governments 15 600 0

2012-03-29-04:00

0938-1163 201304-0938-004 0938
             
        "Long Term Care Hospital (LCTH) Quality Reporting Program"
             
          
        
Section 3004 of the Affordable Care Act authorized the establishment of a new quality reporting program for Long Term Care Hospitals (LTCHs). Section 3004 of the ACA 3004 states that beginning in FY 2014, LTCHs that fail to submit quality measures data to CMS, may be subject to a 2 percentage point reduction in their annual update to the standard Federal rate for discharges occurring during a rate year. CMS implemented The LTCH Quality Reporting Program (LTCHQR Program) in the FY 2012 IPPS/LTCH PPS final rule (76 FR 51743 through 51756) pursuant to Section 3004 of the Affordable Care Act. In this rule, CMS set forth the initial framework for the LTCHQR Program and established the LTCH providers would begin to report quality data on October 1, 2012. The Long-Term Care Hospital (LTCH) Continuity Assessment Record & Evaluation (CARE) Data Set (LTCH CARE Data Set) was developed specifically for use in LTCHs for data collection of quality measure data. The first quality measure data items that were added to the LTCH CARE Data Set were the NQF # 0678 pressure ulcer measure items. In the FY 2013 IPPS/LTCH PPS final rule (76 FR 51743 through 51756), CMS retained the three measures that had been previously adopted in the FY 2012 rule and adopted two new measures (NQF #0680 and NQF #0431) for the FY 2016 payment determination. The new NQF #0680 measure will be collected using the LTCH CARE Data Set. Therefore, the LTCH CARE Data Set must be revised to include additional data items for this new measure. Also, in the FY 2013 IPPS/PPS LTCH Final Rule, it was decided that other revision to the LTCH CARE Data set would be necessary. For a full list of these changes refer to Section 1 of the Supporting Statement A. 2016-06-30-04:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No Yes No 403988 212160 0

Pressure Ulcer Submissions No Health Health Care Services
CMS-10409 LTCH Care Data Set Admissions Yes Yes Fillable Fileable Form and instruction LTCH CARE Data Set_Admission_v2 00_20121120.pdf CMS-10409 LTCH Care Data Set Expired Yes Yes Fillable Fileable Form and instruction LTCH CARE Data Set_Expired_v2 00.pdf CMS-10409 LTCH Care Data Set Unplanned Discharge Yes Yes Fillable Fileable Form and instruction LTCH CARE Data Set_Unplanned Discharge_v2 00_20121120.pdf CMS-10409 LTCH Care Data Set Planned Discharge Yes Yes Fillable Fileable Form and instruction LTCH CARE Data Set_Planned Discharge_v2 00_20121120.pdf
Private Sector 403988 212160 0

2013-06-10-04:00

0938-1164 201304-0938-002 0938
             
        "Medical Loss Ratio Annual Reports, MLR Notices, and Recordkeeping Requirements"
             
          
        
Section 2718 of the PHS Act and its implementing regulation requires health insurance issuers (issuers) offering group or individual health insurance coverage to submit an annual report to the Secretary of the Department of Health and Human Services concerning the amount the issuer spends each year on claims, quality improvement expenses, non-claims costs, Federal and State taxes, licensing and regulatory fees, the amount of earned premium for the reporting year, its medical loss ratio and any rebate it may owe to subscribers. In addition, the implementing regulation requires issuers to maintain all documents and other evidence which support the data that is provided in an issuer's annual report to the Secretary. 2016-05-31-04:00 Active William Parham 4107864669 No Yes No 9868957 303550 0

Annual MLR Report No Health Public Health Monitoring
CMS-10418 MLR_Annual_Form Yes Yes Fillable Fileable Form CMS 10418 MLR PRA Package MLR Form Template.xlsx Yes Yes Fillable Fileable Instruction CMS 10418 2012 MLRA Instructions.pdf Yes Yes Fillable Fileable Instruction CMS 10418 MLRA Instructions.docx
Private Sector 3087 196668 0

Disbursement of Rebate Checks No Health Health Care Services Private Sector 1540728 38518 0

Notice of Rebate to Enrollees No Health Health Care Services
Yes No Fillable Fileable Instruction 2012 0510 MLR Rebate Notice Instructions FINAL.docx CMS-10418 Notice_#1_to_Subscribers_in_Individual_Market Yes Yes Fillable Fileable Form 508CMS-10418_Notice_#1_to_Subscribers_in_Individual_Market.pdf CMS-10418 Notice_#2_Group_Markets_Rebate_to_Policyholder Yes No Fillable Fileable Form 508CMS-10418_Notice_#2_Group_Markets_Rebate_to_Policyholder.pdf CMS-10418 Notice_#3_Group_Markets_Rebate_to_Subscribers Yes No Fillable Fileable Form 508CMS-10418_Notice_#3_Group_Markets_Rebate_to_Subscribers.pdf Yes No Fillable Fileable Instruction 508CMS-10418_MLR_Rebate_Notice_Instructions.pdf Yes No Fillable Fileable Instruction 2012 0510 Guidance re Rebate Notices FINAL.docx
Private Sector 8324640 68048 0

Retention of Records No Health Health Care Services Private Sector 502 316 0

2013-05-03-04:00

0938-1165 201202-0938-006 0938
             
        "Nursing Home Quality Improvement Questionnaire"
             
          
        
The ACA requires CMS to issue a new regulation for QAPI programs, and to develop tools and resources to assist nursing homes in meeting the new QAPI regulation. To help ensure the technical assistance tools and resources are useful to nursing homes, CMS will collect data via the Nursing Home Quality Improvement Questionnaire on current quality improvement activities, challenges, and areas where TA will benefit nursing homes. 2015-06-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 2100 693 0

Nursing Home Quality Improvement Questionnaire No Health Health Care Services
CMS-10366 Hard Copy - Nursing Home Quality Improvement Questionnaire Yes No Fillable Printable Form and instruction QI Questionnaire [rev 02-10-2012].docx CMS-10366 Screen Shots - Nursing Home Quality Improvement Questionnaire Yes Yes Fillable Printable Form and instruction 5378 - Screen Shots_1-27-12.ppt No No Paper Only Other Followup Post Card [rev 02-10-2012].docx No No Paper Only Other CMS Invitation Lette [rev 02-10-2012].docx No No Printable Only Other Questionnaire Information Sheet [rev 02-10-2012].docx
State, Local, and Tribal Governments 2100 693 0

2012-06-01-04:00

0938-1166 201209-0938-009 0938
             
        "Health Plan Identifier, Other Entity Identifier, and Change to National Provider Identifier Requirements"
             
          
        
This collection is needed to fulfill section 1104 of the Affordable Care Act, which calls for Secretary to establish a unique health plan identifier. The Secretary will assign a health plan identifier and other entity identifier and needs to collect information about these entities when assigning an identifier. 2016-05-31-04:00 Active William Parham 4107864669 No Yes No 175000 60300 0

Individuals No Health Health Care Services Individuals or Households 0 0 0

Private Sector No Health Health Care Services Private Sector 0 0 0

Government No Health Health Care Services Private Sector 0 0 0

Health Plan Identifier, Other Entity Identifier, National Provider Identifier Application No Health Health Care Services Individuals or Households 175000 60300 0

2013-05-15-04:00

0938-1167 201305-0938-025 0938
             
        "Community Based Care Transitions Program (CCTP) Implementation and Monitoring"
             
          
        
The Medicare Community-Based Care Transitions Program (CCTP), authorized by Section 3026 of the 2010 Affordable Care Act, is a major component of the Partnership for Patients initiative, one goal of which is to decrease preventable complications during transition from a care setting, such as a hospital, to home, community, or another care setting. Appendix A contains a copy of the relevant portion of the legislation. The CCTP will provide funding to test models for improving care transitions from the hospital to the community for high-risk Medicare beneficiaries. The Centers for Medicare & Medicaid Services (CMS) initiated the CCTP in early 2011 and will operate the program for five years. Congress has authorized $500 million to cover the cost of the program. CMS expects that program agreements will be in place to authorize community-based organizations (CBOs), in partnership with acute care hospitals, to begin providing care transition services in November 2011 and, if successful, continue doing so for up to five years. The planned collection of a participant experience survey is part of the implementation and monitoring strategy that will review the performance of organizations contracted to provide transitional care services under the CCTP. This clearance package seeks approval for the participant experience survey. 2015-06-30-04:00 Active William Parham 4107864669 No Yes No 432000 54000 0

Initial and Terminal Administration of the Survey No Health Health Care Services
CMS-10433 Appendix C_CCTP 1st Admin Participant Exp Survey No No Paper Only Form and instruction Appendix C_CCTP 1st Admin Participant Exp Survey_Clean Version_Final.pdf CMS-10403 CCTP -Spanish Version No No Paper Only Form and instruction Appendix B CCTP items in Spanish.docx CMS-10403 CCTP_2nd_Admin_Participant_Exp_Survey No No Paper Only Form and instruction CCTP_2nd_Admin_Participant_Exp_Survey_Draft_(3-12-12_glui)_Pilot_Test.docx
Private Sector 432000 54000 0

2013-05-30-04:00

0938-1168 201205-0938-006 0938
             
        "Cooperative Agreement to Support Establishment of the Affordable Care Act's Health Insurance Exchanges"
             
          
        
Information collected as a part of the application for this grant will be used to evaluate the applications and determine awardees. Information collected pursuant to the reporting requirements for awardees will be used to evaluate the progress of States in planning for and implementing Exchanges, and determine how the Secretary can provide assistance to achieve the goals of the grant program and the Affordable Care Act. 2015-06-30-04:00 Active William Parham 4107864669 No Yes No 357 50159 0

Funding Opportunity Announcement Application No Health Health Care Services
CMS-10424 FOA Yes Yes Fillable Fileable Form and instruction CMS-10424.FOA Deliberative Document.docx
State, Local, and Tribal Governments 51 28764 0

Progress Report No Health Health Care Services
CMS-10424 Progress Report Yes Yes Fillable Fileable Form and instruction Progress_Report_Instrument.pdf Yes Yes Fillable Fileable Other Form 83 Part II - Progress Report - Data Elements - CLEAN_051512_v3.pdf
State, Local, and Tribal Governments 102 11730 0

Public Report No Health Health Care Services
CMS-10424 Progress Report Yes Yes Fillable Fileable Form and instruction Progress_Report_Instrument.pdf Yes Yes Fillable Fileable Other Form 83 Part II - Progress Report - Data Elements - CLEAN_051512_v3.pdf
State, Local, and Tribal Governments 102 867 0

Establishment Review No Health Health Care Services State, Local, and Tribal Governments 102 8798 0

2012-06-28-04:00

0938-1169 201205-0938-011 0938
             
        "Fee-for-Service Recovery Audit Prepayment Review Demonstration and Prior Authorization Demonstration"
             
          
        
CMS is requesting PRA approval to collect medical records for 2 demonstrations in order to ensure proper payment of claims. The information required under this collection is requested by Medicare contractors to determine proper payment or if there is a suspicion of fraud. Medicare contractors may request the information from providers or suppliers submitting claims for payment from the Medicare program when data analysis indicates aberrant billing patterns or other information which may present a vulnerability to the Medicare program. For items with a history of aberrant billing patterns this information is requested in advance to determine appropriate payment or if there is a suspicion of fraud. 2015-07-31-04:00 Active William Parham 4107864669 No No No 479750 243060 0

Recovery Auditor Pre-payment review Demonstration No Health Health Care Services Private Sector 150000 75000 0

PMD Demonstration No Health Health Care Services Private Sector 325000 162500 0

Signature Attestation No Health Health Care Services Private Sector 4750 5560 0

2012-07-23-04:00

0938-1170 201211-0938-002 0938
             
        "Payments for Services Furnished by Certain Primary Care Providers and Supporting Regulations in 42 CFR 438.6, 438.804, 447.400, and 447.410"
             
          
        
States must submit information to document any expenditure eligible for 100 percent Federal matching funds. The collection of information required under this rule would conform to the new requirements in sections 1902(a)(13), 1902(jj), 1932(f), and 1905(dd) of the Social Security Act, as amended by the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148; the Affordable Care Act). 2014-12-31-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 126059 68185 0

Primary Care Services Furnished by Physicians with a Specified Specialty or Subspeciality No Health Health Care Services State, Local, and Tribal Governments 125970 62985 0

State Plan Requirements - Amending FFS Rate No Health Health Care Services State, Local, and Tribal Governments 51 1020 0

Primary Care Provider Payment Increases No Health Health Care Services State, Local, and Tribal Governments 38 4180 0

Methodology to Identify Rate Differential (FFP for Managed Care Payments) in sec. 438.804(a)(2) and (a)(3) No Health Health Care Services State, Local, and Tribal Governments 0 0 0

2012-12-21-05:00

0938-1171 201209-0938-003 0938
             
        "Inpatient Psychiatric Facility Quality Reporting Program "
             
          
        
Section 10322 of the Affordable Care Act authorizes the establishment of a new quality reporting program for Inpatient Psychiatric Facilities (IPFs). Beginning in FY 2014 and subsequent fiscal years, the quality measures IPFs are required to collect and submit six (6) quality measures to CMS. IPFs failing to submit the quality measures will receive a 2% reduction. In an effort to minimize burden and maximize efficiency, CMS has leverage existing system within CMS to collect aggregated and calculated measure rates from the IPFs, in a form, manner and time as specified by CMS, via a secure portal known as the QualityNet Web site beginning of October 1, 2012 for FY2014 payment determination year. CMS is proposing to implement some procedural requirements to align with current quality reporting programs. These procedural requirements would involve submitting necessary forms to comply with the IPFQR Program and aligns with current CMS reporting requirements for other quality programs. The aforementioned forms are the Notice of Participation From, Decline to Participate Form, Participation Withdrawal Form, Reconsideration Request Form, Disaster Waiver form and the IPFQR notification form letter. 2015-12-31-05:00 Active William Parham 4107864669 No Yes No 471811 1415433 0

Inpatient Psychiatric Facility Quality Reporting Program No Health Health Care Services
CMS-10432 Data Accuracy and Completeness Yes Yes Fillable Fileable Form and instruction IPFQR.DACA form.Aug_27_2012.docx CMS-10432 Notice of Participation Yes Yes Fillable Fileable Form and instruction IPFQR_NOP form.Aug_26_2012.revised.V1.0.docx CMS-10432 Data Collection Yes Yes Fillable Fileable Form and instruction Data collection.July_21_2012.docx CMS-10432 Withdrawal Yes Yes Fillable Fileable Form and instruction Withdrawalform.Aug_24_2012.docx CMS-10432 Decline to Participate Yes Yes Fillable Fileable Form and instruction IPFQR_Decline to participate form_Aug_26_2012.docx CMS-10432 Reconsideration Request Yes Yes Fillable Fileable Form and instruction ReconsiderationRequestPaper Form.Aug_24_2012.docx
Private Sector 471811 1415433 0

2012-12-20-05:00

0938-1172 201211-0938-003 0938
             
        "Blueprint for Approval of Affordable State-based and State Partnership Insurance Exchanges "
             
          
        
CMS is working with States (including the District of Columbia and the territories) to establish Exchanges in every State. The law gives States the opportunity to establish State-based Exchanges, subject to approval that the State-based Exchange meets federal standards and will be ready to offer health care coverage on January 1, 2014. The deadline for Exchange approval is January 1, 2013. In a State that does not achieve Exchange approval by the deadline, the law directs the Secretary of Health and Human Services to facilitate the establishment of an Exchange in that State. States will apply for approval or conditional approval of their State Exchange in the Fall of 2012 with decisions made on January 1, 2013. 2015-08-31-04:00 Active William Parham 4107864669 No Yes No 56 11816 0

Exchange Blueprint No Health Health Care Services
CMS-10416 Exchange Blueprint Yes Yes Fillable Fileable Form and instruction Exchange Blueprint_11152012_CLEAN_.pdf
State, Local, and Tribal Governments 56 11816 0

2012-11-15-05:00

0938-1173 201305-0938-006 0938
             
        "Transparency Reports and Reporting of Physician Ownership or Investment Interests"
             
          
        
Section 6002 of the Affordable Care Act added section 1128G to the Act, which requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare or a State plan under Medicaid or CHIP to report annually to the Secretary certain payments or other transfers of value to physicians and teaching hospitals. Section 1128G of the Act also requires applicable manufacturers and applicable group purchasing organizations (GPOs) to report certain information regarding the ownership or investment interests held by physicians or the immediate family members of physicians in such entities. 2016-07-31-04:00 Active William Parham 4107864669 No Yes No 1570 5232800 0

403.904 and 404.908(a)-(g) - Applicable Manufacturer Data Collection and Reporting No Health Health Care Services
CMS-10419 General Payments (Non-Research) Template Yes No Fillable Fileable Form and instruction CMS-10419_General_Payments_(Non-Research)_Template (5-15-13).pdf CMS-10419 Research Template Yes Yes Fillable Fileable Form CMS-10419_Research Template.pdf CMS-10419 Physician Ownership Template Yes Yes Fillable Fileable Form CMS-10419_Physician_Ownership_Template.pdf
Private Sector 1150 4978000 0

amp;#167;amp;#167;403.906 and 404.908(a)-(g) - Applicable GPO Data Collection and Reporting No Health Health Care Services
CMS-10419 Physician Ownership Template Yes Yes Fillable Fileable Form CMS-10419_Physician_Ownership_Template.pdf CMS-10419 General Payments (Non-Research) Template Yes No Fillable Fileable Form and instruction CMS-10419_General_Payments_(Non-Research)_Template (5-15-13).pdf CMS-10419 Research Template Yes Yes Fillable Fileable Form CMS-10419_Research Template.pdf
Private Sector 420 254800 0

2013-07-26-04:00

0938-1174 201303-0938-003 0938
             
        "Essential Health Benefits Benchmark Plans"
             
          
        
The Affordable Care Act requires that all qualified health plans (QHPs) offered in the Exchanges provide the essential health benefits (EHB) and be accredited by an accrediting entity that is recognized by the Secretary of Health and Human Services. In order to establish EHB benchmark plans in each State, CMS will collect data from potential default benchmark plan issuers in each State and from States that select their own benchmark. CMS also intends to ask all States for a voluntary submission of their State mandated benefits. This data collection will include: administrative data necessary to identify the plan, all health benefits offered by the plans and associated limits, drug coverage, network type, and plan level enrollment. Finally, we plan to collect submissions from dental plan issuers on whether they intend to apply for certification to participate in the Exchanges as stand-alone plans. 2015-08-31-04:00 Active Jamaa Hill 301 492-4190 No Yes No 178 642 0

Essential Health Benefits Benchmark Plans and Accrediting Entities Data Collection No Health Health Care Services
CMS-10448 EHB CMS State Benchmark Yes Yes Fillable Fileable Form and instruction EHBCmsStateBenchmark.xls CMS-10448 EHB Issuer Benchmark Yes Yes Fillable Fileable Form and instruction EHBIssuerBenchmark.xls CMS-10448 State Mandate Template Yes Yes Fillable Fileable Form and instruction StateMandateTemplate.xls Yes Yes Fillable Fileable Instruction Appendix_C-1_EHB Benchmark Submission Instructions 08-14-2012.docx CMS-10448 EHB Prescription Drug Template Yes Yes Fillable Fileable Form and instruction Appendix_C-3_EHB Prescription Drugs Template 07-18-2012.pdf CMs-10448 Prescription Drug Formulary Yes Yes Fillable Fileable Form and instruction PrescriptionDrugFormulary.xls CMS-10448 EHB Benefits Template Yes Yes Fillable Fileable Form and instruction Appendix_C-2_EHB Benefits Template 07-18-2012.pdf CMS-10448 EHB State Submission of State Mandates Template Yes Yes Fillable Fileable Form and instruction 508Appendix_C-5_EHB State Submission of State Mandates 05-24-2012.pdf
Private Sector 158 632 0

EHB Dental Plan Issuers No Health Health Care Services
CMS-10448 Notice of Intent to Provide Dental Coverage in the Exchange Yes Yes Fillable Fileable Form and instruction 508Appendix_C-4_EHB Draft Dental NOI 20120516.pdf
Private Sector 20 10 0

2013-03-08-05:00

0938-1175 201209-0938-004 0938
             
        "PPS-exempt Cancer Hospital Quality Reporting (PCHQR) Program "
             
          
        
Section 3005 of the Affordable Care Act authorizes the establishment of a new quality reporting program for PPS-exempt cancer hospitals (PCHs). Beginning in FY 2014 and subsequent fiscal years, the quality measures PPS-exempt cancer hospitals are required to collect and submit five (5) quality measures to CMS through the Center for Disease Control/National Health Safety Network (CDC/NHSN) and American College of Surgeons'/Commission on Cancer/National Cancer Data Base (ACS/CoC/NCDB). In an effort to minimize burden and maximize efficiency, CMS has leverage two existing systems to collect aggregated and calculated measure rates from the above mentioned entities. These entities will submit the aggregated and calculated measure rates, in a form, manner and time as specified by CMS, via a secure portal known as the QualityNet Web site beginning of October 1, 2012 for FY2014 program year. CMS is proposing to implement some procedural requirements to align with current quality reporting programs. These procedural requirements would involve submitting necessary forms to comply with the PCHQR Program and aligns with current CMS reporting requirements for other quality programs. The aforementioned forms are the Notice of Participation (NOP), Decline Participation, Data Accuracy and Completeness Acknowledgement (DACA), and Intensive Care Unit (ICU) Location Waiver (specifically for the HAI measures) forms. 2015-12-31-05:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No Yes No 27273 68182 0

PPS-exempt Cancer Hosptital Quality Reporitng (PCQR) Program No Health Health Care Services
CMS-10431 Withdrawal Yes Yes Fillable Fileable Form and instruction Withdrawalform.Aug_26_2012_.docx CMS-10431 Decline to Participate Yes Yes Fillable Fileable Form and instruction PCHQR.DeclineParticipation.Aug_26_2012_.docx CMS-10431 HAI Exception Yes Yes Fillable Fileable Form and instruction HAI Exception_Paper Form Aug_27_2012.docx CMS-10431 Data Accuracy and Completeness Yes Yes Fillable Fileable Form and instruction PCHQR.DACA form.Aug_27_2012.docx CMS-10431 Notice of Participation Yes Yes Fillable Fileable Form and instruction PCHQR.NOP.Aug_26_2012.rvised.V1.0.docx
Private Sector 27273 68182 0

2012-12-20-05:00

0938-1176 201308-0938-002 0938
             
        "Recognized Accrediting Entities Data Collection (45 CFR part 156.275)"
             
          
        
The Affordable Care Act requires that all qualified health plans (QHPs) offered in the Exchanges be accredited by an accrediting entity that is recognized by the Secretary of Health and Human Services. In order to recognize accrediting entities for the purposes of certification of qualified health plans, HHS will require the accrediting entities to submit documentation to HHS to demonstrate that they meet the conditions for recognition. HHS also requires that the accrediting entities provide certain data elements to the Exchanges once issuers authorize the release of their accreditation survey data to the Exchange. 2016-09-30-04:00 Active William Parham 4107864669 No Yes No 60 3544 194940

Recognized Accrediting Entities Data Collection No Health Health Care Services
CMS-10449 Appendix C Yes Yes Fillable Fileable Form CMS-10449 Appendix C- AE - 508.pdf Yes Yes Printable Only Instruction Instructions for AE Submission-v2 REVISED 209-13-12.docx
Private Sector 60 3544 194940

2013-09-16-04:00

0938-1177 201305-0938-002 0938
             
        "Medicare Beneficiary and Family-Centered Satisfaction Survey"
             
          
        
The data collection methodology used for the Beneficiary Satisfaction flows from the proposed sampling approach. While it was feasible to conduct the 9th SOW via telephone data collection only, with a quarterly sample size for the 10th SOW estimated to be 2,664, it does not seem efficient to maintain a telephone only data collection approach. Based on recent literature on survey methodology and response rates by mode, we recommend using a data collection that is primarily mail. A mail-based methodology will achieve the goals of being efficient, effective, and minimally burdensome for beneficiary respondents. As previously described, we anticipate that a mail-based methodology could yield a response rate of approximately 60 percent. In order to achieve this response rate, we would recommend a 3 staged approach to data collection: 1) Mailout of a covering letter, the paper survey questionnaire, and a postage-paid return envelope. 2) Mailout of a post card that thanks respondents and reminds the non-respondents to please return their survey. 3) Mailout of a follow-up covering letter, the paper survey questionnaire, and a postage-paid return envelope. Through the pilot test, we will determine the response rate that can be achieved using this approach. If it is deemed necessary, additional mailout reminders can be added to the protocol, or a telephone non-response step can be added to the protocol. Using the 3-step mail approach described above, we anticipate that data collection would occur over an 8 to 10 weeks. 2015-09-30-04:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 68000 17000 85000

Medicare Beneficiary and Family-Centered Satisfaction Survey No Health Health Care Services
CMS-10393 Bene Appeals Survey No No Paper Only Form Bene Survey Appeals (SP) - v1 51512.pdf CMS-10393 Bene Complaint Survey Yes No Paper Only Form Bene Survey Complaint (SP) - v1 51512.pdf
Individuals or Households 68000 17000 85000

2013-06-10-04:00

0938-1178 201206-0938-006 0938
             
        "Medicare Enrollment Application for Physician and Non-Physician Practitioners"
             
          
        
The primary function of the CMS 855I Physician and Non-Physician Practitioners Medicare Enrollment Application is to gather information from a supplier that tells us who they are, whether they meet certain qualifications to be a health care supplier, where they render their services, the identity of individuals that manage their practice, and information necessary to establish the correct claims payment. The goal of periodically evaluating and revising the CMS 855I enrollment application is to simplify and clarify the information collection without jeopardizing our need to collect specific information. 2015-11-30-05:00 Active William Parham 4107864669 No No No 276000 824000 0

Initial enrollment applications No Health Health Care Services
CMS-855I Medicare Enrollment Application for Physician and Non-Physician Practitioners Yes No Fillable Fileable Form and instruction CMS-855I.pdf
Private Sector 36000 144000 0

Revalidation of enrollment No Health Health Care Services
CMS-855I Medicare Enrollment Application for Physician and Non-Physician Practitioners Yes No Fillable Fileable Form and instruction CMS-855I.pdf
Private Sector 160000 640000 0

Changes of enrollment information No Health Health Care Services
CMS-855I Medicare Enrollment Application for Physician and Non-Physician Practitioners Yes No Fillable Fileable Form and instruction CMS-855I.pdf
Private Sector 80000 40000 0

2012-11-01-04:00

0938-1179 201206-0938-007 0938
             
        "Medicare Enrollment Application- Reassignment of Medicare Benefits"
             
          
        
The primary function of the CMS 855R enrollment application is to allow physicians and non-physician practitioners to reassign their Medicare benefits to a group practice and to gather information from the individual that tells us who he/she is, where he or she renders services, and information necessary to establish correct claims payment. The goal of evaluating and revising the CMS 855R enrollment application is to require the physician or non-physician practitioner to identify a primary group location where the physician or non-physician practitioner will render most of his or her services. This identification does not add any additional burden to the physicians or non-physician practitioners. 2015-11-30-05:00 Active William Parham 4107864669 No No No 200000 50000 0

Establishing a reassignment of benefits enrollment application No Health Health Care Services
CMS-855R Reassignment of Medicare Benefits Yes No Fillable Fileable Form and instruction CMS-855R - 01122012.PDF
Private Sector 100000 25000 0

Terminating a Reassignment No Health Health Care Services
CMS-855R Reassignment of Medicare Benefits Yes No Fillable Fileable Form and instruction CMS-855R - 01122012.PDF
Private Sector 100000 25000 0

2012-11-01-04:00

0938-1180 201207-0938-006 0938
             
        "For-Profit PACE Study"
             
          
        
This OMB package requests clearance for an enrollee survey to support an evaluation of the for-profit Program of All-Inclusive Care of the Elderly (PACE) plans. The PACE program aims to provide integrated care and services to the frail elderly at risk of institutionalization to enable them to remain in the community. Under the Balanced Budget Act of 1997, the not-for-profit PACE plans were established as permanent providers under the Medicare and Medicaid programs. The BBA also mandated a demonstration of for-profit PACE plans. A 2005-2006 evaluation was conducted of the PACE program, but it focused solely on the not-for-profit PACE sites because no for-profit PACE plans were operational at that time. The objective of this evaluation is to evaluate the for-profit PACE plans; specifically to understand the extent of variation between the permanent not-for-profit PACE plans and the for-profit PACE plans. The evaluation will address the question of how access to and quality of care delivered to enrollees in for-profit PACE plans differ from not-for-profit PACE plans. The evaluation will analyze the outcome measures of access to and quality of care for enrollees of the not-for-profit and for-profit PACE plans. While the evaluation will use secondary data to identify comparable not-for-profit and for-profit PACE enrollee samples, primary data collection is necessary to obtain the data for the outcome measures. We will conduct a telephone survey of the sampled enrollees to collect data on the patient's health and functional status, access to and satisfaction with health care services, satisfaction with caregivers, and quality of life. The survey for this evaluation is adapted from the survey administered for the evaluation of the not-for-profit PACE programs. 2014-11-30-05:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 813 447 0

For-Profit PACE Study No Health Health Care Services
CMS-10427 PACE Survey No No Fillable Fileable Form and instruction 06965_PACE_OMB_APP_B_06_20_12.docx
Individuals or Households 813 447 0

2012-11-01-04:00

0938-1181 201211-0938-009 0938
             
        "Durable Medical Equipment Face-to-Face Requirements"
             
          
        
To implement section 1834(a) of the Affordable Care Act, CMS published a notice of proposed rulemaking on July 30, 2012 and a final rule on November 16, 2012 (RIN 0938-AR11; CMS-1590-FC). The final rule revises ?410.38(g) by requiring, as a condition of payment for certain covered items of DME, that a physician must document and communicates to the DME supplier that the physician or physician assistant (PA), nurse practitioner (NP), or clinical nurse specialist (CNS) has had a face-to-face encounter with the beneficiary in the 6 months prior to the written order. 2016-03-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 1160000 125667 0

Durable Medical Equipment Scope and Conditions: Physician (sec. 410.38(g)) No Health Health Care Services Private Sector 580000 96667 0

Durable Medical Equipment Scope and Conditions: Physician Assistant, Nurse Practitioner, and Nurse Specialist (sec. 410.38(g)) No Health Health Care Services Private Sector 580000 29000 0

2013-03-20-04:00

0938-1182 201204-0938-005 0938
             
        "Analysis of Transportation Barriers to Utilization of Medicare Services by American Indian and Alaska Native Medicare Beneficiaries"
             
          
        
The purpose of the proposed study is to identify and analyze transportation barriers associated with the utilization of Medicare services by American Indian and Alaska Native (AI/AN) beneficiaries, to identify and analyze the health outcomes resulting from those barriers, and ultimately to identify potential solutions that could help mitigate the problem and produce meaningful improvements in health care use and health outcomes for this population. Specifically, the information that will be collected through the use of instruments and the study developed under the Analysis of Transportation Barriers to Utilization of Medicare Services by American Indian and Alaska Native Medicare Beneficiaries Project has not been collected or evaluated previously by any agency or individual, so data on the extent of transportation barriers for rural AI/AN beneficiaries to Medicare services by AI/AN Medicare beneficiaries are not available except from the proposed data collection activity. The information gathered as part of the project --through the use of survey, interview, and focus group instruments--will be used by CMS to identify transportation barriers to Medicare services for AI/AN Medicare beneficiaries. It will provide the first ever complete evaluation of transportation barriers to health care for this population. 2015-12-31-05:00 Active William Parham 4107864669 No No No 3418 2544 0

Survey No Health Illness Prevention
CMS-10399 Appendix H1 and H2 HEALTH CARE PROVIDER RECRUITMENT LETTERS Yes No Fillable Printable Form and instruction Appendix H1 and H2 HEALTH CARE PROVIDER RECRUITMENT LETTERS.pdf CMS-10399 Appendix G CMS Consent Forms Yes No Fillable Fileable Form and instruction Appendix G CMS Consent Forms.pdf CMS-10399 Appendix E Beneficiaries and Family Members Focus Group Protocol Yes No Fillable Fileable Form and instruction Appendix E Beneficiaries and Family Members Focus Group Protocol.pdf CMS-10399 Appendix D Beneficiaries and Family Members Demographic Survey Yes No Fillable Fileable Form and instruction Appendix D Beneficiaries and Family Members Demographic Survey.pdf CMS-10399 Appendix F Providers Interview Protocol Yes No Fillable Fileable Form and instruction Appendix F Providers Interview Protocol.pdf CMS-10399 Appendix C Beneficiary Interview Protocol Yes No Fillable Fileable Form and instruction Appendix C Beneficiary Interview Protocol.pdf CMS-10399 Appendix A BENEFICIARY TBS Yes No Fillable Fileable Form and instruction Appendix A BENEFICIARY TBS.pdf CMS-10399 Appendix B PROVIDERS TBS Yes No Fillable Fileable Form and instruction Appendix B PROVIDERS TBS.pdf
Individuals or Households 3418 2544 0

2012-12-11-05:00

0938-1183 201206-0938-009 0938
             
        "Surveys of Physicians and Home Health Agencies to Assess Access Issues for Specific Medicare Beneficiaries as Defined in Section 3131(d) of the ACA"
             
          
        
The Centers for Medicare and Medicaid Services (CMS) has contracted with L&M Policy Research (L&M) and its partners, Avalere Health (Avalere), Mathematica Policy Research (MPR), and Social & Scientific Systems, Inc. (SSS) to support the Agency in responding to provisions of the Patient Protection and Affordable Care Act (ACA) Section 3131(d) and concerns that some subsets of the Medicare population may have decreased access to home health services. Findings from this project may result in revisions to the home health prospective payment system (HH PPS) to ensure that home health agencies (HHAs) are adequately reimbursed for providing services to vulnerable populations as defined by the ACA - low income beneficiaries, those living in medically underserved areas, and beneficiaries with high levels of severity of illness. The research team plans to conduct two surveys in order to help identify characteristics of beneficiaries who are difficult to place in home health care. To learn more about the beneficiaries who experience access issues, respondent specific surveys have been developed to administer to (1) physicians who refer vulnerable patients to the Medicare home health benefit, and (2) Medicare certified home health agencies. Both target populations offer unique perspectives on the characteristics of Medicare beneficiaries who may have access issues and can help answer questions that cannot be addressed as well through other research methods (primarily through analysis of administrative claims). 2015-12-31-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 875 219 0

(Physician) Survey of Access to Home Health Services for Medicare Beneficiaries No Health Health Care Services
No Paper Only Other Physician cover letter REVISED 11-19-12.pdf No Paper Only Other HHSC_Physician prenotice letter REVISED 11-19-2012.pdf CMS-10429 (Physician) Survey of Access to Home Health Services for Medicare Beneficiaries No No Fillable Printable Form HHSC_Physician Survey [rev 6-27-2012].pdf No No Fillable Printable Instruction HHSC_Prompting script 03292012_508.pdf No No Printable Only Other HHSC_Physician postcard text 03292012_508.pdf
Private Sector 275 69 0

(Home Health Agencies) Survey of Access to Home Health Services for Medicare Beneficiaries No Health Health Care Services
No No Fillable Printable Instruction HHSC_Prompting script 03292012_508.pdf No No Printable Only Other HHSC_HHA prenotice letter 03292012_508.pdf No No Printable Only Other HHSC_HHA postcard text 04122012_508.pdf No No Printable Only Other HHSC_HHA cover letter 03292012_508.pdf CMS-10429 (Home Health Agencies) Survey of Access to Home Health Services for Medicare Beneficiaries No No Fillable Printable Form HHSC_HHA Survey [rev 6-27-20012].pdf
Private Sector 600 150 0

2012-12-11-05:00

0938-1184 201210-0938-008 0938
             
        " Minimum Data Set for Medicaid Incentives for Prevention of Chronic Diseases Program Grantees "
             
          
        
The Medicaid Incentives for Prevention of Chronic Diseases (MIPCD) program provides grants to states to implement programs that provide incentives to Medicaid beneficiaries of all ages who participate in prevention programs and demonstrate changes in health risk and outcomes, including the adoption of healthy behaviors. The proposed information collection, the MIPCD Minimum Data Set (MDS), is intended to collect data for program performance monitoring and evaluation. The MDS is a secondary data collection that assembles information already collected by grantees in the course of tracking beneficiary participation and outcomes and performing their own evaluation activities. 2015-12-31-05:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No Yes No 40 3467 0

MEDICAID INCENTIVES FOR PREVENTION OF CHRONIC DISEASES (MIPCD) MINIMUM DATA SET No Health Health Care Services
CMS-10444 Minimum Data Set WI Yes Yes Fillable Fileable Form and instruction MIPCD_MDS_Data_Elements_WI_07232012_508.docx CMS-10444 Minimum Data Set TX Yes Yes Fillable Fileable Form and instruction MIPCD_MDS_Data_Elements_TX_07232012_508.docx CMS-10444 Minimum Data Set NY Yes Yes Fillable Fileable Form and instruction MIPCD_MDS_Data_Elements_NY_07232012_508.docx CMS-10444 Minimum Data Set NV Yes Yes Fillable Fileable Form and instruction MIPCD_MDS_Data_Elements_NV_07232012_508.docx CMS-10444 Minimum Data Set NH Yes Yes Fillable Fileable Form and instruction MIPCD_MDS_Data_Elements_NH_07232012_508.docx No No Paper Only Instruction MIPCD_MDS_Format_Transmission_Instructions_07232012_508.docx CMS-10444 Minimum Data Set HI Yes Yes Fillable Fileable Form and instruction MIPCD_MDS_Data_Elements_HI_07232012_508.docx CMS-10444 Minimum Data Set MT Yes Yes Fillable Fileable Form and instruction MIPCD_MDS_Data_Elements_MT_07232012_508.docx CMS-10444 Minimum Data Set CT Yes Yes Fillable Fileable Form and instruction MIPCD_MDS_Data_Elements_CT_07232012_508.docx CMS-10444 Minimum Data Set CA Yes Yes Fillable Fileable Form and instruction MIPCD_MDS_Data_Elements_CA_07232012_508.docx CMS-10444 Minimum Data Set MN Yes Yes Fillable Fileable Form and instruction MIPCD_MDS_Data_Elements_MN_07232012_508.docx
State, Local, and Tribal Governments 40 3467 0

2012-12-21-05:00

0938-1185 201210-0938-003 0938
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery"
             
          
        
This collection of information is necessary to enable the Agency to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the agency's programs. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. 2015-12-31-05:00 Active William Parham 4107864669 No No No 1000000 25000 0

Beneficiary Contact Center Customer Satisfaction Survey No Health Health Care Services
CMS-10415 IVR Phone Script for Survey Yes Yes Fillable Fileable Form and instruction OMB IVR Phone Script 2013.docx
Individuals or Households 145000 5776 0

Evaluation of Stakeholder Training - Health Insurance Marketplace and Market Stabilization Programs No Health Health Care Services
0938-1185 Stakeholder Training Forms Yes Yes Fillable Fileable Form and instruction Instruments.docx
Individuals or Households 100000 417 0

2012-12-21-05:00

0938-1186 201302-0938-001 0938
             
        "Home and Community-Based Services (HCBS) Experience Survey"
             
          
        
The goal of this survey is to provide standard performance metrics for HCBS programs that are applicable to all populations served by these programs, including people with physical disabilities, cognitive disabilities, intellectual impairments, and/or disabilities due to mental illness. 2016-02-29-05:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 18000 9000 0

Home and Community-Based Services (HCBS) Experience Survey No Health Health Care Services
Yes No Fillable Printable Instruction Attachment C Contact Script_revised_clean.docx CMS-10389 Consent Form (English) Yes Yes Fillable Printable Form Consent form_9_12_12_English.docx Yes Yes Fillable Printable Other Field test cover letter template_English .doc CMS-10389 Survey Instruments Yes Yes Fillable Printable Form and instruction Attachement B_Survey_Instruments_9_18_12.docx Yes Yes Fillable Printable Other Field test cover letter template_Spanish.doc CMS-10389 Consent Form (Spanish) Yes Yes Fillable Printable Form Consent form_Spanish.docx
Individuals or Households 18000 9000 0

2013-02-04-05:00

0938-1187 201303-0938-004 0938
             
        "Initial Plan Data Collection to Support QHP Certification and other Financial Management and Exchange Operations"
             
          
        
As required by the CMS-9989-F: Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers ("Exchange rule"), each Exchange must assume responsibilities related to the certification and offering of Qualified Health Plans ("QHP"). To offer insurance through an Exchange, a health insurance issuer must have its health plans certified as QHPs by the Exchange. A QHP must meet certain minimum certification standards, such as network adequacy, actuarial value standards, and the offering of the essential health benefits (EHB). The Exchange is responsible for ensuring that QHPs meet these minimum certification standards as described in the Exchange rule under 45 CFR 155 and 156, based on the Affordable Care Act, as well as other requirements determined by the Exchange. 2016-03-31-04:00 Active Jamaa Hill 301 492-4190 No Yes No 3490 203469 0

QHP Certification No Health Health Care Services
CMS-10433 IssuersNCQA Yes Yes Fillable Fileable Form and instruction 12 - IssuersNCQA.xls CMS-10433 Appendix A 6 Network Adequacy Template Yes Yes Fillable Fileable Form and instruction 13 - Appendix A 6 Network Adequacy Template.xls CMS-10433 Appendix A 4 EssentialCommunityProviders Template Yes Yes Fillable Fileable Form and instruction 11 - Appendix A 4 EssentialCommunityProviders Template.xls CMS-10433 Appendix A 3 AdministrativeData Template Yes Yes Fillable Fileable Form and instruction 10 - Appendix A 3 AdministrativeData Template.xls CMS-10433 Appendix A 2 Program Attestations Yes Yes Fillable Fileable Form and instruction 9 - Appendix A 2 Program Attestations.pdf CMS-10433 Appendix A 1 Issuer data elements Yes Yes Fillable Fileable Form and instruction 8 - Appendix A 1 Issuer data elements.pdf CMS-10433 IssuerURAC Yes Yes Fillable Fileable Form and instruction 12 - IssuerURAC.xls CMS-10433 Appendix B 1 QHP Benefit Elements Yes Yes Fillable Fileable Form and instruction 14 - Appendix B 1 QHP Benefit Elements.pdf CMS-10433 PlansBenefits Yes Yes Fillable Fileable Form and instruction 15-PlansBenefits.xlsm CMS-10433 Appendix B 4 ServiceArea Template Yes Yes Fillable Fileable Form and instruction 17 - Appendix B 4 ServiceArea Template.xls CMS-10433 Appendix C 3 RatingBusinessRules Template Yes Yes Fillable Fileable Form and instruction 20 - Appendix C 3 RatingBusinessRules Template.xls CMS-10433 Appendix C 2 RateTables Template Yes Yes Fillable Fileable Form and instruction 19 - Appendix C 2 RateTables Template.xls CMS-10433 Appendix C 1 Rating Tables and Issuer Business Rules Yes Yes Fillable Fileable Form and instruction 18 - Appendix C 1 Rating Tables and Issuer Business Rules .pdf CMS-10433 PlansBenefitsAddIn Yes Yes Fillable Fileable Form and instruction 15 - PlansBenefitsAddIn.xlam CMS-10433 Appendix B 3 PrescriptionDrug Template Yes Yes Fillable Fileable Form and instruction 16 - Appendix B 3 PrescriptionDrug Template.xls
Private Sector 1240 186186 0

Reinsurance and Risk Adjustment No Health Health Care Services
CMS-10433 Appendix D 1 RI, RA, Banking, Edge Server Data Elements Yes Yes Fillable Fileable Form and instruction 21 - Appendix D 1 RI, RA, Banking, Edge Server Data Elements.pdf
Private Sector 600 3800 0

Reinsurance No Health Health Care Services
CMS-10433 Appendix D 1 RI, RA, Banking, Edge Server Data Elements Yes Yes Fillable Fileable Form and instruction 21 - Appendix D 1 RI, RA, Banking, Edge Server Data Elements.pdf
Private Sector 1600 13333 0

States No Health Health Care Services State, Local, and Tribal Governments 50 150 0

2013-03-13-04:00

0938-1188 201301-0938-004 0938
             
        "Medicaid and CHIP Program (MACPro)"
             
          
        
CMS is in the process of evaluating Medicaid systems currently operating, in order to build an enterprise architecture platform and data repository. Ideally, CMS would allow for a single point of entry to access various program and operational data applications. This effort will be implemented in phases over several years. Phase 1 will provide for a Medicaid and CHIP Program data system (MACPro) accessed through a web portal/portlet that will automate the input and retrieval of data from the states related to CHIP eligibility and Alternative Benchmark Plans (ABP). This system will also support an efficient workflow for the review and approval of the CHIP and ABP process. States will access this system and submit program information into structured data templates. CMS staff will review the templates for compliance with federal statute, regulation and policy, provide feedback to the states and track/monitor the review and approval process. Future project phasing will provide for the design, delivery and implementation of financial management programs and performance and quality metrics. CMS must meet a hard deadline for the implementation of the Affordable Care Act. This system will be operational in phases with the CHIP eligibility and benchmark plans portions/modules to be implemented in January 2013. 2016-03-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 280 2772 0

MACPro Home Page No Health Health Care Services
CMS-10434 MACPro Homepage Yes Yes Fillable Fileable Form MACPro Home Page.jpg
State, Local, and Tribal Governments 56 28 0

Initial Application No Health Health Care Services
Yes No Printable Only Instruction IG_I1_State Information_R1_Draft_11-30-12.docx Yes No Printable Only Instruction IG_I5 - Public Comment_R1_Draft_11-30-12.docx Yes No Printable Only Instruction IG_I2 - Medicaid State Plan-Specific Submission Data_R1_Draft_11-30-12.docx Yes No Printable Only Instruction IG_I6 - Tribal Input_R1_Draft_11-30-12.docx CMS-10434 Initial Application Yes Yes Fillable Fileable Form and instruction Initial Application Form.pdf Yes No Printable Only Instruction IG_I4 - CHIP Amendment Submission_R1 Final_11-30-12.docx
State, Local, and Tribal Governments 56 280 0

Medicaid Administration No Health Health Care Services
Yes No Printable Only Instruction IG_A3-Assurances_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_A1-Designation and Authority_R1_Final_11-30-12.docx CMS-10434 Medicaid Administration Yes Yes Fillable Fileable Form and instruction Medicaid Admin Form.pdf Yes No Printable Only Instruction IC_A2-Organization and Administration_R1_Final_11-30-12.docx
State, Local, and Tribal Governments 56 168 0

CHIP Administration & Eligibility No Health Health Care Services
Yes No Printable Only Instruction IG_CS23 - Non-Financial Requirement-Other Eligibility Standards_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CS22 - Non-Financial Requirements_R1_Draft_11-30-12.docx CMS-10434 CHIP Administration Yes Yes Fillable Fileable Form and instruction CHIP Admin Form.pdf Yes No Printable Only Instruction IG_CS20 - Non-Financial-Substitution of Coverage_R1_Draft_11-30-12.docx Yes No Printable Only Instruction IG_CS19 - Non-Financial-Social Security Number_R1_Draft_11-30-12.docx Yes No Printable Only Instruction IG_CS18 - Non-Financial-Citizenship_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CS17 - Non-Financial-Residency_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CS16 - Spenddown_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CS15 - MAGI-Based Income Methodologies_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CS14 - Children Inelig for Medicaid as a Result of the Elim of Income Disregards_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CS13 - Deemed Newborns_R1_Draft_11-30-12.docx Yes No Printable Only Instruction IG_CS12 - Dental Only Supplemental Coverage_R1_Final_ 11-30-12.docx Yes No Printable Only Instruction IG_CS11 - Pregnant Women Who Have Access to Public Employee Coverage_R1_Draft_11-30-12.docx Yes No Printable Only Instruction IG_CS10- Children with Access to Public Employee Coverage_R1_Draft_11-30-12.docx Yes No Printable Only Instruction IG_CS9 - Coverage from Conception to Birth_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CS8 - Targeted Low-Income Pregnant Women_R1_Final_ 11-30-12.docx Yes No Printable Only Instruction IG_CS7 - Targeted Low-Income Child_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CS6 - Income Standards_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CS5 - Completion of Covered Groups_R1_Final_11-30-12 .docx Yes No Printable Only Instruction IG_CS4 - Separate CHIP Covered Groups_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CS3 - Medicaid Expansion_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CHIP Eligibility Introduction_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CHIP Admin Introduction_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CA4 - CHIP State Plan Administration-Assurances_R1_Draft_11-30-12.docx Yes No Printable Only Instruction IG_CA3- Organization and Administation_R1_Final_ 11-30-12.docx Yes No Printable Only Instruction IG_CA2 - Designation and Authority_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CA1 - Program Type Designation_R1_Final_ 11-30-12.docx Yes No Printable Only Instruction IG_CS24 - Eligibility Processing_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CS25 - Beginning Date of Eligibility_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CS26 - Ending Dates of Eligibility_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CS27 - Continuous Eligibility_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CS28 - Presumptive Eligibility for Children_R1_Draft_11-30-12.docx Yes No Printable Only Instruction IG_CS29 - Presumptive Eligibility for Pregnant Women_R1_Draft_11-30-12.docx Yes No Printable Only Instruction IG_CS30 - Qualified Entities_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CS32 - Express Lane Eligibility_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CS33 - Express Lane Agencies_R1_Final_11-30-12.docx Yes No Printable Only Instruction IG_CS34 - Express Lane Eligibility Components_R1_Final_11-30-12.docx CMS-10434 CHIP Eligibility Yes Yes Fillable Fileable Form and instruction CHIP Eligibility Form.pdf Yes No Printable Only Instruction IG_CS21 - Non-Financial-Non-Payment of Premiums_R1_Draft_11-30-12.docx
State, Local, and Tribal Governments 56 1568 0

Alternative Benefit Plan (ABP) No Health Health Care Services
Yes No Printable Only Instruction B9 ABP Employer Spon Ins_Draft_111912.docx Yes No Printable Only Instruction B8 ABP Service Del Systems_Draft_111912.docx Yes No Printable Only Instruction B7 ABP Benchmark Equiv Assur_Draft_111912.docx Yes No Printable Only Instruction B6 ABP Benchmark Equiv_Draft_111912.docx Yes No Printable Only Instruction B5 AB Plan Benefit Assurances_Draft_111912.docx Yes No Printable Only Instruction B4d ABP Sec-Approved Package_Draft_111612.docx Yes No Printable Only Instruction B4a,b,c ABP Benefit Packages_Draft_111912.docx Yes No Printable Only Instruction B4 AB Plans Select-Cost Shar_Draft_111912.docx Yes No Printable Only Instruction B3b AB Plans Mand Assurances_Draft_111912.docx Yes No Printable Only Instruction B1 AB Plans Amendement_Draft_111912.docx Yes No Printable Only Instruction AB Plans General Background 111612.docx CMS-10434 ABP Yes Yes Fillable Fileable Form and instruction ABP Form.pdf Yes No Printable Only Instruction B3a AB Plan Vol Assurances_Draft_111912.docx Yes No Printable Only Instruction B2 AB Plans Populations_Draft_111912.docx Yes No Printable Only Instruction B18 AB Plan Components_Draft_111912.docx Yes No Printable Only Instruction B17 ABP State Benefits Table_Draft_111912.docx Yes No Printable Only Instruction B16 ABP Payment Methodologies_Draft_111912.docx Yes No Printable Only Instruction B15 ABP Termination Phase Out_Draft_111912.docx Yes No Printable Only Instruction B14 ABP Base Benchmark Admin_Draft_111912.docx Yes No Printable Only Instruction B11,12,13 ABP Admin Table_Draft_111912.docx Yes No Printable Only Instruction B10 ABP General Assurances_Draft_111912.docx
State, Local, and Tribal Governments 56 728 0

2013-03-20-04:00

0938-1189 201309-0938-029 0938
             
        "Minimum Essential Coverage"
             
          
        
The NPRM titled "Patient Protection and Affordable Care Act; Exchange Functions: Eligibility for Exemptions; Miscellaneous Minimum Essential Coverage Provisions" proposes to designate certain types of health coverage as minimum essential coverage. Other types of coverage, not statutorily designated and not designated as minimum essential coverage in this regulation, may be recognized as minimum essential coverage if certain substantive and procedural requirements are met. The proposed rule would require coverage recognized to be minimum essential coverage to offer substantially the same consumer protections as those enumerated in the Title I of Affordable Care Act relating to non-grandfathered, individual coverage to ensure consumers are receiving adequate coverage. The proposed rule would require sponsors of individual coverage that seek to have such coverage designated as minimum essential coverage to adhere to certain procedures. Sponsoring organizations would have to submit to HHS information about their coverage and an attestation that the plan substantially complies with the provisions of Title I of the Affordable Care Act as applicable to non-grandfathered individual health insurance coverage. Sponsors would also have to a notice to enrollees informing them that the plan has been designated minimum essential coverage for the purposes of the individual coverage requirement. 2016-09-30-04:00 Active Jamaa Hill 301 492-4190 No Yes No 10 53 2200

Minimum Essential Coverage Certification No Health Health Care Services
CMS-10465 Minimum Essential Coverage Certification (WORD) Yes Yes Fillable Printable Form and instruction CMS-10465 MEC Certification_final rev clean.docx CMS-10465 Minimum Essential Coverage Certification (optional Excel file) Yes Yes Fillable Printable Form MEC Application - Applicant and plan information.xlsx
Private Sector 10 53 2200

2013-09-30-04:00

0938-1190 201311-0938-010 0938
             
        "Patient Protection and Affordable Care Act; Exchange Functions: Eligibility for Exemptions"
             
          
        
The final rule entitled "Exchange Functions: Eligibility for Exemptions" provides standards with regard to the minimum function of an Exchange to perform eligibility determinations and issue certificates of exemption from the shared responsibility payment. The final rule implements standards related to eligibility for exemptions, including the verification and eligibility determination process, eligibility redeterminations, options for conducting eligibility determinations, and reporting related to exemptions. 2016-12-31-05:00 Active Jamaa Hill 301 492-4190 No Yes No 12000108 3263605 600000

Exemption Applications - Eligibility for Exemptions No Health Health Care Services
CMS-10466 Application Exemption - Hardships Yes No Fillable Printable Form and instruction Application_Exemption_Hardship-12192013-508.pdf CMS-10466 Exemption Application - Health Care Sharing Ministries Yes No Fillable Printable Form and instruction Application_Exemption_SharingMinistry-12-18-2013 508 final.pdf CMS-10466 Exemption Application - Shared Responsibility SBM's Yes No Fillable Printable Form and instruction Application_Exemption_SharedResponsibility_SBM-121813 pre508 final.pdf CMS-10466 Application Exemptions Shared Responsibility for FFM's Yes No Fillable Printable Form and instruction Application_Exemption_SharedResponsibility_FFM-12-18-13 508 final 2103 p....pdf CMS-10466 Application Exemptions - Incarerated Yes No Fillable Printable Form and instruction Application_Exemption_Incarcerated_12-18-2013_508_final.pdf CMS-10466 Exemption Application - Federally Recognized Tribes Yes No Fillable Printable Form and instruction Application_Exemption_Tribe-121813-pre508 final.pdf CMS-10466 Application for Exemptions Religious Sects or Divisions Yes No Fillable Printable Form and instruction Application for Exemption for religious sect_121813-508-final.pdf
Individuals or Households 12000000 3240000 0

Application Development No Health Health Care Services Private Sector 18 19062 0

Eligibility Notices No Health Health Care Services Private Sector 18 2250 600000

Verification of New and Changed Applications No Health Health Care Services Private Sector 18 22 0

Redeterminations No Health Health Care Services Private Sector 18 3 0

Periodic Electronic Notifications No Health Health Care Services Private Sector 18 378 0

Agreements No Health Health Care Services Private Sector 18 1890 0

2013-12-19-05:00

0938-1191 201302-0938-004 0938
             
        "Data Collection to Support Eligibility Determinations for Insurance Affordability Programs and Enrollment through Health Benefits Exchanges, Medicaid and Children's Health Insurance Program Agencies"
             
          
        
Section 1413 of the Affordable Care Act directs the Secretary of HHS to develop and provide to each State a single, streamlined form that may be used to apply for coverage through the Exchange and Insurance Affordability Programs. A state may develop and use its own single streamlined application if approved by the Secretary in accordance with section 1413 and if it meets the standards established by the Secretary. 2016-04-30-04:00 Active Jamaa Hill 301 492-4190 No Yes No 3035434 1428822 0

Individual Application No Health Health Care Services
CMS-10440 CMS_10440_AttachmentD-Application for Health Coverage Yes No Fillable Fileable Form and instruction CMS-10440.AttachmentD-Application for Health Coverage.pdf CMS-10440 CMS-10440_AttachmentA-Individual Online Application Questionnaire Yes Yes Fillable Fileable Form and instruction CMS-10440.AttachmentA-Individual Online Application Questionnaire.pdf CMS-10440 AttachmentC-Application for Health Coverage & Help Paying Costs Yes No Fillable Fileable Form and instruction CMS-10440.AttachmentC-Application for Health Coverage & Help Paying Costs.pdf
Individuals or Households 2776698 1407261 0

Application for Health Coverage and Help Paying Costs Short Form No Health Health Care Services
CMS-10440 CMS-10440.AttachmentB-Application for Health Coverage & Help Paying Costs (Short Form) Yes Yes Fillable Fileable Form and instruction CMS-10440.AttachmentB-Application for Health Coverage & Help Paying Costs (Short Form).pdf
Individuals or Households 258736 21561 0

2013-04-30-04:00

0938-1192 201207-0938-001 0938
             
        "Probable Fraud Measurement Pilot"
             
          
        
The goal of this pilot is to develop the first nationally representative estimate of the extent of probable fraud in payments for home health care services in the fee-for-service Medicare program. The instruments will be used to conduct interviews with Medicare beneficiaries, home health agency (HHA) staff, and referring providers. 2016-05-31-04:00 Active William Parham 4107864669 No No No 6000 7500 0

Beneficiaries No Health Health Care Services
CMS-10406 Instrument No No Fillable Fileable Form and instruction CMS-10406.Instrument.docx
Individuals or Households 2000 1250 0

HHA's No Health Health Care Services
CMS-10406 Instrument No No Fillable Fileable Form and instruction CMS-10406.Instrument.docx
Private Sector 2000 3000 0

Referring Providers No Health Health Care Services
CMS-10406 Instrument No No Fillable Fileable Form and instruction CMS-10406.Instrument.docx
Private Sector 2000 3250 0

2013-05-16-04:00

0938-1193 201302-0938-003 0938
             
        "Data Collection  to Support Eligibility Determinations and Enrollment for Small Businesses in the Small Business Health Options Program"
             
          
        
On March 23, 2010, the President signed into law H.R. 3590, the Patient Protection and Affordable Care Act, Public Law 111-148, as amended by the Health Care and Education Reconciliation Act of 2010, Pub. L. 111-152, collectively referred to as "The Affordable Care Act." The Affordable Care Act expands access to health insurance coverage through improvements to the Medicaid and Children's Health Insurance (CHIP) programs, the establishment of Affordable Insurance Exchanges (Exchanges), and the assurance of coordination between Medicaid, CHIP, and Exchanges. Through the Small Business Health Options Program (SHOP), the new Exchanges will assist qualified small employers in facilitating the enrollment of their employees in Qualified Health Plans (QHPs) offered in the small group market. The Exchanges, which will offer these QHPs, will become operational on January 1, 2014. Employers will be able to begin applying for coverage through the SHOP October 1, 2013, for coverage beginning as early as January 1, 2014. The employer's application for the SHOP will be a single, streamlined form that will be used to determine employer eligibility for the SHOP. The submission seeks OMB approval of the data collection elements needed to support eligibility determinations for small businesses in the SHOP. 2016-05-31-04:00 Active Jamaa Hill 301 492-4190 No Yes No 177777 36089 0

SHOP - Employer No Health Health Care Services
CMS-10439 Appendix B SHOP Employer Application Yes No Fillable Fileable Form and instruction SHOP ApplicationforEmployers.052313-508.pdf CMS-10439 Appendix A SHOP Employer Questionnaire Yes Yes Fillable Fileable Form and instruction CMS-10439.Appendix_A (SHOP- Employer)-5-9-13.docx
Private Sector 177777 36089 0

2013-05-31-04:00

0938-1194 201302-0938-002 0938
             
        "Data Collection  to Support Eligibility Determinations and Enrollment for Employees in the Small Business Health Options Program"
             
          
        
On March 23, 2010, the President signed into law H.R. 3590, the Patient Protection and Affordable Care Act, Public Law 111-148, as amended by the Health Care and Education Reconciliation Act of 2010, Pub. L. 111-152, collectively referred to as "The Affordable Care Act." The Affordable Care Act expands access to health insurance coverage through improvements to the Medicaid and Children's Health Insurance (CHIP) programs, the establishment of Affordable Insurance Exchanges (Exchanges), and the assurance of coordination between Medicaid, CHIP, and Exchanges. Through the Small Business Health Options Program (SHOP), the new Exchanges will assist qualified employers who are small employers in facilitating the enrollment of their employees in Qualified Health Plans (QHPs) offered in the small group market. The Exchanges, which will offer these QHPs, will become operational on January 1, 2014. Qualified employees of employers participating in the SHOP will be able to begin applying for enrollment in QHPs through the SHOP October 1, 2013, for coverage beginning as early as January 1, 2014. The employee's application for the SHOP will be a single, streamlined form that will be used to determine employee eligibility. The submission seeks OMB approval of the data collection elements needed to support eligibility determinations for employees in the SHOP. 2016-05-31-04:00 Active Jamaa Hill 301 492-4190 No Yes No 888888 180178 0

SHOP - Employee No Health Health Care Services
CMS-10438 Appendix_A-SHOP_Employee_List_of_Questions Yes Yes Fillable Fileable Form and instruction CMS-10438-AppendixA_SHOP_Employee 5-10-13.docx CMS-10438 Appendix_B-SHOP_Employee_Application Yes No Fillable Fileable Form and instruction SHOP Application forEmployees.052313-508.pdf
Individuals or Households 888888 180178 0

2013-05-31-04:00

0938-1195 201303-0938-002 0938
             
        "Medicare Advantage Quality Bonus Payment Demonstration"
             
          
        
This data collection effort is part of the evaluation of the Medicare Advantage Quality Bonus Payment Demonstration, which accelerates the phase-in of QBPs mandated by the Affordable Care Act (ACA). The data collection is needed by CMS as part of the evaluation of the QBP demonstration to better understand what impact the demonstration has had on Medicare Advantage Organization (MAO) operations and their efforts to improve quality. The data collection instrument for the survey is a survey questionnaire designed to capture information on how MAOs perceive the demonstration and are planning for or implementing changes in quality initiatives and to identify factors that help hinder the capacity to achieve quality improvement and that influence the decision calculus to make changes. The research team plans to conduct this data collection effort in the form of a survey of MAOs and up to 10 case studies with MAOs in order to supplement what can be learned from the research team's analyses of administrative and financial data for MAOs. The case studies will be conducted as a series of open-ended discussions with MAO staff that will be guided by a discussion protocol. 2016-06-30-04:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No Yes No 620 610 0

Medicare Advantage Quality Bonus Payment Demonstration MAO mail survey No Health Health Care Services
CMS-10445 Initial Call Form Yes Yes Fillable Fileable Form and instruction Appendix C_Initial Call Form.docx CMS-10445 QBP MAO Survey Yes Yes Fillable Fileable Form and instruction QBP MAO Survey_02.01.2013_508.docx CMS-10445 Reminder Call Script Yes Yes Fillable Fileable Form and instruction Appendix D_Reminder Call Script.docx
Private Sector 620 610 0

2013-06-10-04:00

0938-1196 201303-0938-009 0938
             
        "Home Health Change of Care Notice (HHCCN)"
             
          
        
The Centers for Medicare and Medicaid Services (CMS) requests a new collection named the Home Health Change of Care Notice (HHCCN), Form CMS -10280, to replace, in part, the existing, previously approved Office of Management and Budget (OMB) notice, titled the Home Health Advance Beneficiary Notice (HHABN) (CMS-R-296). The use of written notices to inform beneficiaries of their liability under specific conditions has been available since the "limitation on liability" provisions in ?1879 of the Act were enacted in 1972 (P.L. 92-603). The revised Advanced Beneficiary Notice of Noncoverage (ABN) for conveying information on beneficiary liability is approved by OMB, consistent with the Paperwork Reduction Act of 1995 (PRA); however, HHAs have been historically excluded from using the ABN as a liability notice for their services and have used the HHABN exclusively. In an effort to streamline, reduce, and simplify appeals notices issued to Medicare beneficiaries, the appeals portion of the HHABN will be replaced by the existing ABN (CMS -R-131) which is presently used by providers other than HHAs to inform Fee For Service (FFS) Medicare beneficiaries of potential liability for certain items/services that might be billed to Medicare. Pursuant to a separate PRA package revising the use of the ABN, HHAs will now use the ABN for liability notification, and the HHCCN will be introduced as a separate, distinct document to give change of care notice in compliance with HHA COPs. 2016-06-30-04:00 Active William Parham 4107864669 No No No 14126428 941385 0

Notice No Health Health Care Services
Yes No Fillable Fileable Instruction CMS-10280_HHCCNForm InstructionsOct2012v508.pdf CMS-10280 Home Health Change of Care Notice Yes No Fillable Fileable Form CMS-10280_Instrument.pdf
Private Sector 14126428 941385 0

2013-06-10-04:00

0938-1197 201211-0938-011 0938
             
        "Health Insurance Common Claims Form and Supporting Regulations at 42 CFR Part 424, Subpart C"
             
          
        
Medicare Administrative Contractors use the data collected on the CMS-1500 and the CMS-1490S to determine the proper amount of reimbursement for Part B medical and other health services (as listed in section 1861(s) of the Social Security Act) provided by physicians and suppliers to beneficiaries. The CMS-1500 is submitted by physicians/suppliers for all Part B Medicare. Serving as a common claim form, the CMS-1500 can be used by other third-party payers (commercial and nonprofit health insurers) and other Federal programs (e.g., TRICARE, RRB, and Medicaid). 2016-06-30-04:00 Active William Parham 4107864669 No No No 988005045 21418336 0

CMS-1500 (02-12)/CMS-1490S No Health Health Care Services
CMS-1490S PATIENT'S REQUEST FOR MEDICAL PAYMENT Yes Yes Fillable Fileable Form and instruction CMS1490S English.pdf CMS-1500(02-12) Claim Form Yes Yes Fillable Fileable Form and instruction CMS 1500 (front_back) (02-12).pdf
Private Sector 988005045 21418336 0

2013-06-10-04:00

0938-1198 201302-0938-005 0938
             
        "Medicare Enrollment Application for Clinics/ Group Practice and Certain Other Suppliers"
             
          
        
The primary function of the CMS 855B enrollment application for Clinics, Group Practices and Certain Other Suppliers is to gather information from the organization that tells us what it is, whether it meets certain qualifications to be a health care supplier, where it renders services and information necessary to establish the correct claims payment. The goal of evaluating and revising the CMS 855B enrollment application is to simplify and clarify the information collection without jeopardizing our need to collect specific information. The majority of the revisions are very minor in nature such as spelling and formatting corrections, removal of duplicate fields and instruction clarification for the organization/group. The Sections and Sub-Sections within the form are also being re-numbered and re-sequenced to create a more logical flow of the data collection. In addition, CMS is adding a data collection for an address to mail the periodic request for the revalidation of enrollment information (only if it differs from other addresses currently collected). Other than the revalidation mailing address described above, new data being collected in this revision package is a checkbox indicating whether or not an organization is wholly owned or operated by a hospital, the inclusion of a new supplier type (Centralized Flu Biller) and information on, if applicable, where the supplier stores its patient records electronically. 2016-06-30-04:00 Active William Parham 4107864669 No Yes No 31000 103000 0

Initial Enrollment No Health Health Care Services
CMS-855B Medicare Enrollment Application for Clinics/ Group Practice and Certain Other Suppliers Yes Yes Fillable Fileable Form and instruction CMS-855B_112812.pdf
Private Sector 10000 40000 0

Revalidation of Enrollment No Health Health Care Services
CMS-855B Medicare Enrollment Application for Clinics/ Group Practice and Certain Other Suppliers Yes Yes Fillable Fileable Form and instruction CMS-855B_112812.pdf
Private Sector 14000 56000 0

Change of Information No Health Health Care Services
CMS-855B Medicare Enrollment Application for Clinics/ Group Practice and Certain Other Suppliers Yes Yes Fillable Fileable Form and instruction CMS-855B_112812.pdf
Private Sector 7000 7000 0

2013-06-10-04:00

0938-1199 201304-0938-001 0938
             
        "MAC Satisfaction Indicator (MSI) Participant Registry"
             
          
        
Section 1874(A)(b)(3)(B) of the Social Security Act requires that provider satisfaction be considered as a performance standard for the work of Medicare Administrative Contractors (MACs). 2016-06-30-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No No No 150000 2500 0

MSI Participant Registration Information No Health Health Care Services
CMS-10457 MSI Participant Registration Information Yes Yes Fillable Printable Form and instruction MSI Participant Registration Information 1-8-13.pdf
Private Sector 150000 2500 0

2013-06-10-04:00

0938-1200 201303-0938-007 0938
             
        "Evaluation and Development of Outcome Measures for Quality Assessment in Medicare Advantage and Special Needs Plans"
             
          
        
Quality improvement is a major initiative for the Centers for Medicare and Medicaid Services (CMS). With the passing of the Patient Protection and Affordable Care Act in March 2010, there is a focused interest in providing quality and value-based healthcare for Medicare beneficiaries. It is critical to develop criteria not only for quality improvement but also as a means for beneficiaries to compare healthcare plans to make the choice that is right for them. Process of care measures are needed that focus on the care needs of Medicare beneficiaries, such as factors affecting continuity of care and transitions. CMS seeks also to expand its quality improvement efforts from collection of structure and process measures to outcome measures. The development and subsequent implementation of outcome measures appropriate for programs serving older and/or disabled patients is especially important for ensuring that these beneficiaries obtain high quality healthcare. This request is for data collection to test the use of new tools available to CMS to measure care pertinent to vulnerable beneficiaries where quality of care provided by Medicare Advantage Organizations (MAOs) should be closely monitored. The measures to be evaluated and developed upon approval of this request relate to (1) continuity of information and care from hospital discharge to the outpatient setting, (2) continuity between mental health provider and primary care provider (PCP), and (3) items that may be added to the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey addressing language centered care, cultural competence, physical activity, healthy eating, and caregiver strain. 2016-06-30-04:00 Active William Parham 4107864669 No No No 2720 1540 0

Abstracting Information from Medical Records No Health Health Care Services
CMS-10451 Instruments Yes No Fillable Fileable Form and instruction CMS-10451.Instrument.docx
Individuals or Households 720 540 0

Amended CAHPS Survey No Health Health Care Services
CMS-10451 Instruments Yes No Fillable Fileable Form and instruction CMS-10451.Instrument.docx
Individuals or Households 2000 1000 0

2013-06-10-04:00

0938-1201 201212-0938-003 0938
             
        "Medicare Plan Finder Experiment"
             
          
        
The purpose of this experiment is to test the effects of two prospective enhancements to the Medicare Plan Finder (MPF) website. We refer to these prospective enhancements as the "Quick Links" and "enhanced data display."The Quick Links home page, which was developed as an alternative to the current MPF home page, is intended to provide a quick overview of all of the most common uses of MPF data, a succinct explanation of each of those uses, and a direct conduit to comparative data on plans. The enhanced data display is designed as a more consumer-friendly alternative to the current data display. In particular, the enhanced data display is meant to make plan data more easily evaluable and operable, and to draw greater attention to plan quality data. 2016-06-30-04:00 Active William Parham 4107864669 No No No 600 252 0

Medicare Plan Finder Experiment No Health Health Care Services
CMS-10441 Attachment_I-post_survey_conditions_1_and_2 Yes Yes Fillable Fileable Form and instruction Attachment_I-post_survey_conditions_1_and_2_508_083112.pdf CMS-10441 Attachment_C-a Yes Yes Fillable Fileable Form and instruction Attachment_C-a.pdf CMS-10441 Attachment_A-a Yes Yes Fillable Fileable Form and instruction Attachment_A-a.pdf CMS-10441 Attachment_D-a Yes Yes Fillable Fileable Form and instruction Attachment_D-a.pdf CMS-10441 Attachment_F-a Yes Yes Fillable Fileable Form and instruction Attachment_F-a.pdf CMS-10441 Attachment_G-a Yes Yes Fillable Fileable Form and instruction Attachment_G-a.pdf CMS-10441 Attachment H - pre-exposure survey 100112 Yes Yes Fillable Fileable Form and instruction Attachment H - pre-exposure survey 100112.pdf CMS-10441 Attachment_B-a Yes Yes Fillable Fileable Form and instruction Attachment_B-a.pdf CMS-10441 Attachment K - post survey conditions 5 and 6 Yes Yes Fillable Fileable Form and instruction Attachment K - post survey conditions 5 and 6 - 100112.pdf CMS-10441 Attachment M - post survey conditions 9 and 10 Yes Yes Fillable Fileable Form and instruction Attachment M - post survey conditions 9 and 10 100112.pdf CMS-10441 Attachment O - post survey conditions 13 and 14 Yes Yes Fillable Fileable Form and instruction Attachment O - post survey conditions 13 and 14 - 100112.pdf CMS-10441 Attachment P - post survey conditions 15 and 16 Yes Yes Fillable Fileable Form and instruction Attachment P - post survey conditions 15 and 16 - 100112.pdf CMS-10441 Attachment_E-a Yes Yes Fillable Fileable Form and instruction Attachment_E-a.pdf CMS-10441 Attachment J - post survey conditions 3 and 4 - 100112 No Yes Fillable Fileable Form and instruction Attachment J - post survey conditions 3 and 4 - 100112.pdf CMS-10441 Attachment L - post survey conditions 7 and 8 No No Fillable Fileable Form and instruction Attachment L - post survey conditions 7 and 8 - 100112.pdf CMS-10441 Attachment N - post survey conditions 11 and 12 Yes Yes Fillable Fileable Form and instruction Attachment N - post survey conditions 11 and 12 - 100112.pdf
Individuals or Households 600 252 0

2013-06-10-04:00

0938-1202 201211-0938-005 0938
             
        "Transcatheter Valve Therapy Registry and KCCQ-10"
             
          
        
The data collection is required by the Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) entitled, "Transcatheter Aortic Valve Replacement (TAVR)". The TAVR device is only covered when specific conditions are met including that the heart team and hospital are submitting data in a prospective, national, audited registry. CMS finds that the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry, one registry overseen by the National Cardiovascular Data Registry, meets the requirements specified in the NCD on TAVR. The TVT Registry will support a national surveillance system to monitor the safety and efficacy of the TAVR technologies for the treatment of aortic stenosis. 2016-06-30-04:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 24000 7000 0

TVT Registry No Health Consumer Health and Safety
CMS-10443 TVT Data Collection Form Yes Yes Fillable Fileable Form and instruction TVT_v1_1_DataCollectionForm_Final.sflb.pdf
Private Sector 6000 4900 0

KCCQ-10 No Health Consumer Health and Safety
CMS-10443 KCCQ-10 Yes Yes Fillable Fileable Form and instruction short kccq 2012-01-31.DOCX
Individuals or Households 18000 2100 0

2013-06-10-04:00

0938-1203 201305-0938-007 0938
             
        "Consumer Research Supporting Outreach for Health Insurance Marketplace"
             
          
        
The Centers for Medicare and Medicaid Services is requesting clearance for two surveys to aid in understanding levels of awareness and customer service needs associated with the Health Insurance Marketplace established by the Affordable Care Act. Because the Marketplace will provide coverage to the almost 50 million uninsured in the United States through individual and small employer programs, we have developed one survey to be administered to individual consumers most likely to use the Marketplace and another to be administered to small employers most likely to use the Small Business Health Options portion of the Marketplace. These brief surveys, designed to be conducted quarterly, will give CMS the ability to obtain a rough indication of the types of outreach and marketing that will be needed to enhance awareness of and knowledge about the Marketplace for individual and business customers. CMS' biggest customer service need is likely to be providing sufficient education so consumers: a) can take advantage of the Marketplace and b) know how to access CMS' customer service channels. The surveys will provide information on media use, concept awareness, and conceptual or content areas where education for customer service delivery can be improved. Awareness and knowledge gaps are likely to change over time based not only on effectiveness of CMS' marketing efforts, but also of those of State, local, private sector, and nongovernmental organizations. 2016-06-30-04:00 Active William Parham 4107864669 No Yes No 40200 2480 0

Individual Screener No Health Health Care Services
CMS-10458 Individual Screener Yes No Fillable Fileable Form and instruction CMS-10458_Individual_Marketplace_Screener_(REVISED).pdf
Individuals or Households 30000 940 0

Individual Survey No Health Health Care Services
CMS-10458 Individual Survey Yes No Fillable Fileable Form and instruction CMS-10458_Individual_Marketplace_Tracking_Survey_(REVISED).pdf
Individuals or Households 6000 1200 0

SHOP Screener No Health Health Care Services
CMS-10458 SHOP Screener Yes No Fillable Fileable Form and instruction CMS-10458_SHOP_Tracking_Screener.pdf
Private Sector 3000 100 0

SHOP Survey No Health Health Care Services
CMS-10458 SHOP Survey Yes No Fillable Fileable Form and instruction CMS-10458_SHOP_Tracking_Survey_12_20_12.pdf
Private Sector 1200 240 0

2013-06-18-04:00

0938-1204 201305-0938-019 0938
             
        "Agent/Broker Data Collection in Federally-facilitated Health Insurance Exchanges"
             
          
        
The Center for Consumer Information and Insurance Oversight (CCIIO), the agency within Centers for Medicare & Medicaid Services (CMS) charged with helping implement many provisions of the Affordable Care Act including the establishment of Affordable Insurance Exchanges (Exchanges), needs to collect data from individual agent/brokers to register them with the Federally-facilitated Exchange (FFE) and provide the required training in Exchange enrollment policies and procedures. Both section 1312(e) of the Affordable Care Act and 45 CFR ?155.220 permit States to allow agent/brokers to enroll individuals, employers, and employees in Qualified Health Plans (QHPs), including through the Exchanges; and assist individuals in applying for advance payments of the premium tax credit and cost-sharing reductions. Agent/brokers will serve as additional access points to the Exchange for individuals or SHOP employers/employees requiring or desiring agent/broker assistance. Agent/brokers must register with the FFE and meet training requirements that enforce their understanding of eligibility and enrollment in Exchanges prior to enrolling individuals or SHOP employer/employees in QHPs through the Exchanges. They must also apply this understanding to the development of any non-Exchange Web site used as a tool for enrollment. Agent/broker designed and administered web sites or tools will improve the flow of information to the FFE, and State-based Exchanges may also find these tools useful toward streamlining data submissions and easing the burden on the Exchange. The collection of information from agent/brokers described in detail below is needed to register and completion training with the FFE. Collected information will be used by CMS/CCIIO to verify the completion of the training requirement, provide the public with a list of registered agent/brokers trained in Exchange enrollment requirements and functions, and perform oversight of agent/brokers operating through the FFE. 2016-07-31-04:00 Active Jamaa Hill 301 492-4190 No Yes No 350000 175000 0

Agents/Broker Data Collection in Federally Facilitated Health Insurance Exchanges No Health Health Care Services
CMS-10464 Learning Management System Yes Yes Fillable Fileable Form and instruction CMS-10464-30_day_Appendix_A_LMS_screen_shots[1].pdf
Private Sector 350000 175000 0

2013-07-18-04:00

0938-1205 201308-0938-016 0938
             
        "Standards for Navigators and Non-Navigator Assistance Personnel; Consumer Assistance Tools and Programs of an Exchange and Certified Application Counselors"
             
          
        
Section 1413 of the Affordable Care Act directs the Secretary of HHS to establish, subject to minimum requirements, a streamlined enrollment system for qualified health plans offered through the Exchange and insurance affordability programs. In addition, section 1321(a)(1) of the Affordable Care Act directs and authorizes the Secretary to issue regulations setting standards for meeting the requirements under title I of the Affordable Care Act, with respect to, among other things, the establishment and operation of Exchanges. Pursuant to this authority, regulations establishing the certified application counselor program are being finalized at 45 CFR ?155.225. Specifically, 45 CFR ?155.225(a) requires an Exchange to establish a certified application counselor program that complies with the requirements of the rule. Section155.225(b)(1) allows each Exchange to designate certain organizations, including organizations designated by state Medicaid or CHIP agencies, which will certify their staff and volunteers to act as certified application counselors. In accordance with 45 CFR ?155.225(b)(2), Exchanges may choose to certify directly individuals who seek to act as certified application counselors, designate certain organizations which will certify staff or volunteers to perform application services, or do both. 2016-08-31-04:00 Active Jamaa Hill 301 492-4190 No Yes No 4596000 667740 0

??155.225(b)(1) (organization designation by Exchange) No Health Health Care Services Private Sector 5000 5000 0

??155.225(b)(1) (organization follow-up for application) No Health Health Care Services Private Sector 1000 500 0

??155.225(b)(1)(i) (organization attestation) No Health Health Care Services Private Sector 5000 1250 0

??155.225(b)(1) (organization list) No Health Health Care Services Private Sector 5000 1250 0

??155.225(b)(1)(i) (certificate issuance) No Health Health Care Services Private Sector 30000 480 0

??155.225(d)(2) and (f) (organization record of authorization) No Health Health Care Services Private Sector 2200000 70400 0

??155.225(d)(2) and (f) (CAC authorization to consumer) No Health Health Care Services Private Sector 2200000 585200 0

155.225(b)(1)(ii) - Issuance of unique registration identification number No Health Health Care Services
CMS-10494 Registration Yes Yes Fillable Fileable Form and instruction CMS-2334-F2-APPENDIX A.PDF
Private Sector 30000 900 0

155.225(b)(1)(ii) - Identification number record retention No Health Health Care Services
CMS-10494 Registration Yes Yes Fillable Fileable Form and instruction CMS-2334-F2-APPENDIX A.PDF
Private Sector 30000 480 0

155.225(d)(1) - Training Registration No Health Health Care Services
CMS-10494 Registration Yes Yes Fillable Fileable Form and instruction CMS-2334-F2-APPENDIX A.PDF
Private Sector 30000 900 0

155.225(d)(1) - Training certificate proof No Health Health Care Services
CMS-10494 Registration Yes Yes Fillable Fileable Form and instruction CMS-2334-F2-APPENDIX A.PDF
Private Sector 30000 900 0

155.225(d)(1) - Training certificate retention No Health Health Care Services
CMS-10494 Registration Yes Yes Fillable Fileable Form and instruction CMS-2334-F2-APPENDIX A.PDF
Private Sector 30000 480 0

2013-08-16-04:00

0938-1206 201210-0938-007 0938
             
        "Evaluation of Patient Satisfaction and Experience of Care for Medicare Beneficiaries with ESRD: Impact of the ESRD Prospective Payment System (PPS) and ESRD Quality Incentive Program (QIP)"
             
          
        
The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) directed the Secretary of HHS to implement a payment system under which providers or renal dialysis facilities receive a single payment for renal dialysis services in lieu of any other payment. The end-stage renal disease (ESRD) prospective payment system (PPS or "bundled payment") combines composite rate dialysis services with separately billable services under a single payment adjusted to reflect patient differences in resource needs or case-mix. MIPPA also stipulated the development of quality incentives for the ESRD program, known as the ESRD Quality Incentive Program (QIP). The ESRD QIP reduces ESRD payments by up to 2.0 percent for dialysis providers and facilities that fail to meet or exceed a specified performance score. The Centers for Medicare and Medicaid Services (CMS) is planning a qualitative and quantitative evaluation of the impact of the recently implemented ESRD PPS/QIP on beneficiary satisfaction and experience of care. To support its review of the legislative impact on satisfaction and care, CMS will conduct two separate data collection efforts: one with ESRD beneficiaries and one with stakeholders in the renal care community. The quantitative data collection effort for this study will include 2,500 telephone interviews with 2,500 ESRD beneficiaries. CMS will assess beneficiary experiences using the current version of the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH-CAHPS) Survey. The qualitative data collection effort for this study will include interviews of 40 key stakeholder professionals in the renal care community. The focus of these interviews will include an assessment of whether there are missing domains or topics in the current ICH-CAHPS Survey (to support future modifications to the survey instrument). 2016-08-31-04:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 2540 662 0

Evaluation of Patient Satisfaction and Experience of Care for Medicare Beneficiaries with ESRD No Health Health Care Services Private Sector 2540 662 0

2013-08-14-04:00

0938-1207 201307-0938-007 0938
             
        "Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes, and Premiums and Cost Sharing; Exchanges: Eligibility and Enrollment"
             
          
        
The Patient Protection and Affordable Care Act expands access to health insurance for individuals and employees of small businesses through the establishment of new Affordable Care Exchanges, inlcuding the Small Business Health Options Program. The reporting and data collection in the Exchange rule address federal requirements that states must meet with respect to the establishment and operation of an Exchange; minimum requirements that health insurance issuers must meet with respect to participation in a state based or federally-facilitated Exchange; and requirements that employers must meet with respect to participation in the SHOP and compliance with other provisions of the Affordable Care Act. The data collection and reporting requirements in the final rule entitled Medicaid and Children's Health Insurance Programs: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes, and Premiums and Cost Sharing; Exchanges: Eligibility and Enrollment (Eligibility II FInal Rule) addresss several Exchange provisions including specific provisions including those related to authorized representatives, notices, and verification of eligibility for qualifying coverage in an eligible employer-sponsored plan for Affordable Insurance Exchanges. The submission seeks OMB approval of the information collection requirements associated with 45 CFR parts 155, 156, and 157. 2016-08-31-04:00 Active Jamaa Hill 301 492-4190 No Yes No 5348316 12845827 337523177

Employers - Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes, and Premiums and Cost Sharing; Exchanges: Eligibility and Enrollment No Health Health Care Services State, Local, and Tribal Governments 1 68 4030

Exchanges - Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes, and Premiums and Cost Sharing; Exchanges: Eligibility and Enrollment No Health Health Care Services State, Local, and Tribal Governments 18 9846 576436

Individual - Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing andAppeal Processes, and Premiums and Cost Sharing; Exchanges: Eligibility and Enrollment No Health Health Care Services State, Local, and Tribal Governments 5348297 12835913 336942711

2013-08-16-04:00

0938-1208 201306-0938-006 0938
             
        "Hospice Experience of Care Survey"
             
          
        
Hospice currently serves approximately 42% of dying patients in the United States. Medicare covers most hospice patients under a benefit created in 1983 to provide palliative care at the end of life. Despite its 30-year history as a Medicare benefit, to date no single survey has been systematically administered by all hospices across the country to assess experiences of hospice care. The Hospice Experience of Care Survey will support the Affordable Care Act and enhance Medicare's capacity to evaluate hospice care and assess the value of hospice services to patients and their families. This submission is in support of a field test of the survey. The field test is intended to examine how well items in the instrument perform under real-world survey administration conditions and how appropriate they are for making objective comparisons between hospices across the U.S. In addition, CMS plans to submit the instrument for certification as a Consumer Assessment of Healthcare Providers and Systems (CAHPS?) survey, which requires a field test as part of the certification process. 2016-08-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 730 185 0

Hospice Experience of Care Survey No Health Health Care Services
CMS-10475 Hospice Experience Survey - Home Version No No Fillable Printable Form and instruction 508_Hospice_Survey_Attachment A_HOME REVISED 2013_5_30.pdf CMS-10475 Hospice Experience Survey - Nursing Home Version No No Fillable Printable Form and instruction 508_Hospice_Survey_Attachment B_NURSING HOME REVISED 2013_5_30.pdf No No Fillable Printable Other 508_Hospice_Survey_Attachment E_Telephone Consent Script DRAFT 2013_5_30.pdf CMS-10475 Hospice Experience Survey - Inpatient Version No No Fillable Printable Form and instruction 508_Hospice_Survey_Attachment C_INPATIENT REVISED 2013_5_30.pdf No No Printable Only Other 508_Hospice_Survey_Attachment D_Survey Cover Letter.pdf
Individuals or Households 730 185 0

2013-08-23-04:00

0938-1209 201305-0938-001 0938
             
        "Emergency Room Patient Experiences with Care Survey"
             
          
        
The Emergency Department patient experience of care survey supports the six national priorities for improving care from the National Quality Strategy developed by the U.S. Department of Health and Human Services (HHS) that was called for under the Affordable Care Act to create national aims and priorities to guide local, state, and national efforts to improve the quality of health care. This strategy has established six priorities that support a three-part aim focusing on better care, better health, and lower costs through improvement. The six priorities include: making care safer by reducing harm caused by the delivery of care; ensuring that each person and family are engaged as partners in their care; promoting effective communication and coordination of care; promoting the most effective prevention and treatment practices for the leading causes of mortality, starting with cardiovascular disease; working with communities to promote wide use of best practices to enable healthy living; and making quality care more affordable for individuals, families, employers, and governments by developing and spreading new health care delivery models. This survey will provide patient experience of care data that enables making comparisons of emergency departments across the nation and promoting effective communication and coordination. The Centers for Medicare & Medicaid Services (CMS) has already implemented patient experience surveys in a number of settings including traditional Medicare, Medicare Advantage, and Part D Prescription Drug Plans, hospitals, and home health agencies. While CMS and/or the Agency for Healthcare Research and Quality (AHRQ) have developed additional Consumer Assessment of Healthcare Providers and Systems (CAHPS?) surveys for in-center hemodialysis facilities, nursing homes and clinician and group practices, none of these surveys address patients' experiences with emergency department services. 2015-08-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 3600 799 0

Emergency Department Patient Experience of Care Survey No Health Health Care Services
No No Fillable Printable Other ATTACHMENT G ER Patient Experiences Survey Telephone Script 4-25-13.doc CMS-10461 ER Patient Experience Survey - Admitted to Hospital (HCAHPS Add On) Version No No Fillable Printable Form 508 ATTACHMENT C ER Patient Experience Survey Admitted to Hospital HCAHPS Add-on 4-25-13.docx CMS-10461 ER Patient Experience Survey - Discharge Version No No Fillable Printable Form 508 ATTACHMENT A ER Patient Experience Survey Discharged to community 4-25-13.docx CMS-10461 ER Patient Experience Survey - Admitted to Hospital Stand Alone Version No No Fillable Printable Form 508-ATTA.DOC
Individuals or Households 3600 799 0

2013-08-23-04:00

0938-1210 201301-0938-009 0938
             
        "Report of a Hospital Dealth Associated with Restraint or Seclusion"
             
          
        
The Hospital Restraint/Seclusion Death Report Worksheet historically has been used by RO's internally as a data collection tool for hospitals reporting restraint/seclusion deaths as required by 482.13. In response to the Executive Order 13563 by reducing unnecessarily burdensome rules and thereby increasing the ability of hospitals and CAHs to devote resources to providing high quality patient care. The Medicare and Medicaid Programs; Reform of Hospital and Critical Access Hospital Conditions of Participation CMS-3244-F final rule responds. Within this rule is the change to 482.13 reducing the burden of reporting 2-point soft wrist restraint deaths. Additionally, it increases the methods for which hospitals may report all other restraint/seclusion related deaths, to include telephone, facsimile, and electronic. The Hospital Restraint/Seclusion Death Report Worksheet will now be used by all hospitals for required reporting by facsimile and electronic. Sections 1861(e)(1) through (8) of the Social Security Act (the Act) provide that a hospital participating in the Medicare program must meet certain specified requirements. Section 1861(e)(9) of the Act specifies that a hospital also must meet such other requirements as the Secretary finds necessary in the interest of the health and safety of individuals furnished services in the institution. Under this authority, the Secretary has established regulatory requirements that a hospital must meet to participate in Medicare at 42 CFR Part 482, CoPs for Hospitals. Section 1905(a) of the Act provides that Medicaid payments from States may be applied to hospital services. Under regulations at 42 CFR 440.10(a)(3)(iii), 42 CFR 440.20(a)(3)(ii), and 42 CFR 440.140, hospitals are required to meet the Medicare CoPs in order to participate in Medicaid. 2016-08-31-04:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 24500 8085 0

Hospital Restraint/Seclusion Death Report Worksheet No Health Health Care Services
CMS-10455 Health Death Report Form Yes Yes Fillable Fileable Form Hospital DeathReport Form 22 jan 13 with corrections.doc CMS-10455 Screenshot Yes Yes Fillable Fileable Form and instruction DRS screens 06142012.docx CMS-10455 Intake Yes Yes Fillable Fileable Form and instruction DRS screen print 08092012.docx
Private Sector 24500 8085 0

2013-08-23-04:00

0938-1211 201304-0938-009 0938
             
        "Evaluation of the Multi-Payer Advanced Primary Care Practice Demonstration"
             
          
        
The Multi-payer Advanced Primary Care Practice (MAPCP) Demonstration was announced by Secretary Kathleen Sebelius in September 2009 to allow Medicare to join state Medicaid programs and private insurers in participating states to improve the delivery of primary care. CMS selected eight states to participate in this demonstration: Maine, Vermont, Rhode Island, New York, Pennsylvania, North Carolina, Michigan, and Minnesota. CMS is conducting an evaluation of the demonstration to assess the effects of advanced primary care practice when supported by Medicare, Medicaid, and private health plans. As part of this evaluation, n person, semi-structured interviews with be conducted with (1) physicians and administrators of medical home practices and/or health systems (including North Carolina's care managers and community based care networks, Pennsylvania's physician organizations, and Michigan's provider organizations, (2) individuals representing physician associations, (3) individuals representing payer organizations, (4) individuals representing Office of Aging Staff and patient advocates; (5) leaders of community health teams and networks including respondents from Vermont's Support and Services at Home program; and (6) state officials including respondents from North Carolina's Division of Aging and Adult Services. 2016-08-31-04:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No No No 472 478 0

MAPCP -- Practice/Health System Physicians and Administrators No Health Health Care Services
CMS-10436 Protocol - Practice No No Paper Only Form and instruction Protocol_Practice_2-13-13.pdf CMS-10436 Protocol-Organized Delivery No No Paper Only Form and instruction Protocol_organized_delivery_2-13-13.pdf CMS-10436 Protocol - Provider Organization No No Paper Only Form and instruction Protocol_provider_org_2-13-13.pdf
Private Sector 288 288 0

MAPCP - Individuals Representing Physician Associations No Health Health Care Services
CMS-10436 Protocol - Physician Associations No No Paper Only Form and instruction Protocol_Phys_Assoc_2-13-13.pdf
Private Sector 16 16 0

MAPCP - Individuals Representing Payer Organizations No Health Health Care Services
CMS-10436 Protocol - Payers No No Paper Only Form and instruction Protocol_Payers_2-13-13.pdf
Private Sector 48 48 0

MAPCP - Individuals Representing Office of Aging and Patient Advocates No Health Health Care Services
CMS-10436 Protocol - Advocates No No Paper Only Form and instruction Protocol_Advocates_2-13-13.pdf
State, Local, and Tribal Governments 48 36 0

MAPCP - Individuals Representing Community Health Teams and Networks No Health Health Care Services
CMS-10436 Protocol - SASH No No Paper Only Form and instruction Protocol_SASH_2-13-13.pdf CMS-10436 Protocol - Community Health Teams No No Paper Only Form and instruction Protocol_CHT_2-13-13.pdf CMS-10436 Protocol - Networks No No Paper Only Form and instruction protocol_networks_2-13-13.pdf
Private Sector 24 18 0

MAPCP - State Officials No Health Health Care Services
CMS-10436 Protocol - DAAS care managers No No Printable Only Form and instruction protocol_DAAS_care_mgrs_2-13-13.pdf CMS-10436 Protocol - State Officials No No Paper Only Form and instruction Protocol_State_2-14-13.pdf
State, Local, and Tribal Governments 48 72 0

2013-08-23-04:00

0938-1212 201307-0938-004 0938
             
        "Evaluation of the Graduate Nurse Education Demonstration Program"
             
          
        
The demand for Advanced Practice Registered Nurse(APRN)-provided care has increased in recent years because of the shortage of primary-care physicians and the rise in the demand for primary-care services and expected to continue increasing as more Americans acquire access to health care coverage due to the Affordable Care Act. The Graduate Nurse Education Demonstration aims to increase the supply of APRNs in the U.S. health care delivery system by providing Medicare payments to five selected hospitals for the reasonable cost of providing clinical training to APRN students. This demonstration also involves the creation of partnerships between hospitals, schools of nursing (SONs), and community-based care settings (CCSs). The program evaluation will determine: 1. The growth in the number of APRNs with respect to a specific base year as a result of the demonstration. 2. The growth for each of the following specialties: clinical nurse specialist, nurse practitioner, certified nurse anesthetist, certified nurse-midwife. 3. The costs to the Medicare program as result of the demonstration. The former will analyze the implementation of the demonstration and allow for course corrections during the demonstration period. The latter evaluation will measure the change in key data elements from baseline. Data pertaining to all stages of the demonstration, including historical, baseline, transition, implementation and post-implementation stages are needed. The purpose of this data collection is, thus, to obtain quantitative and qualitative data from the hospitals, SONS, CCSs of five demonstration sites. The qualitative data will be obtained through key stakeholder interviews, small discussion groups and focus groups, and telephone interviews with administrators, preceptors, and APRN students. Quantitative data elements include characteristics of: o APRN applicants, current students, and alumni o Preceptors o Nursing faculty o Partner hospitals o SONs o CCSs 2016-09-30-04:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No Yes No 595 6740 0

Qualititative Data Collection No Health Consumer Health and Safety
CMS-10467 Consent Form for Student Focus Groups No No Paper Only Form and instruction GNEStudentConsentFormCompliant.pdf CMS-10467 Consent Form for Key Informant Interviews and Focus Groups No No Paper Only Form and instruction GNEKeyConsentFormCompliant.pdf CMS-10467 GNE Qualitative Data Collection Protocols for First In-Person Site Visit No No Paper Only Form and instruction GNESteVist1ProtocolT1.pdf CMS-10467 GNE Qualititave Data Collection Protocols for Interim Check-in No No Paper Only Form and instruction GNEInterimChckInProtocolT2.pdf CMS-10467 GNE Qualitative Data Collection Protocols for Second In-Person Site Visit No No Paper Only Form and instruction GNESteVist2ProtocolT3.pdf
Private Sector 590 700 0

Quantitative Data Collection No Health Consumer Health and Safety
CMS-10467 Quantitative Data Collection Protocol No No Paper Only Form and instruction QuantiProtocolCertified.pdf
Private Sector 5 6040 0

2013-09-06-04:00

0938-1213 201309-0938-019 0938
             
        "Program Integrity and Additional State Information Collections"
             
          
        
The data collections and third-party disclosure requirements will assist HHS in determining Exchange compliance with Federal standards. The data collection and third-party disclosure requirements will also assist HHS in monitoring QHP issuers in FFEs for compliance with Federal QHP issuer standards. The data collected by health insurance issuers and Exchanges will help to inform HHS, Exchanges, and health insurance issuers as to the participation of individuals, employers, and employees in the individual Exchange, the SHOP, and the premium stabilization programs. 2016-11-30-05:00 Active Jamaa Hill 301 492-4190 No Yes No 432468 1773090 0

155.220(c)(3)(vii) No Health Health Care Services Private Sector 50 800 0

155.220(c)(4) No Health Health Care Services Private Sector 50 2600 0

155.220(g)(2) No Health Health Care Services Private Sector 2 36 0

155.260 - Navigators No Health Health Care Services Private Sector 264 1188 0

155.260 - Certified Application Counselors No Health Health Care Services Private Sector 3000 9000 0

155.260 - Agents and Brokers No Health Health Care Services Private Sector 254095 1524570 0

155.310(k) No Health Health Care Services Private Sector 1 1 0

Appeals - Appeal Form No Health Health Care Services Private Sector 19020 38040 0

Appeals No Health Health Care Services State, Local, and Tribal Governments 77314 115971 0

Evidence Submission No Health Health Care Services State, Local, and Tribal Governments 1 2 0

Forms - Appeal Withdrawal, Request to Vacate a Dismissal, Special Considerations and Appointment of Authorized Representative No Health Health Care Services State, Local, and Tribal Governments 1 2 0

Notice of Appeals Actions No Health Health Care Services State, Local, and Tribal Governments 18 1890 0

Records Storage No Health Health Care Services State, Local, and Tribal Governments 18 3240 0

Notices No Health Health Care Services State, Local, and Tribal Governments 77314 1800 0

155.115 - Habilitative Services No Health Health Care Services Private Sector 50 50 0

156.135 No Health Health Care Services State, Local, and Tribal Governments 51 1020 0

156.1010 No Health Health Care Services Private Sector 1200 72000 0

156.1230(a)(1) No Health Health Care Services Private Sector 1 610 0

156.1230(a)(2) No Health Health Care Services State, Local, and Tribal Governments 18 270 0

45 CFR 156.715 No Health Health Care Services Private Sector 0 0 0

45 CFR 156.715 No Health Health Care Services Private Sector 0 0 0

45 CFR 156.901-156.963 No Health Health Care Services Private Sector 0 0 0

45 CFR 156.1010 No Health Health Care Services State, Local, and Tribal Governments 0 0 0

45 CFR 156.1210 No Health Health Care Services Private Sector 0 0 0

45 CFR 156.1230 No Health Health Care Services State, Local, and Tribal Governments 0 0 0

45 CFR 156.1210 No Health Health Care Services State, Local, and Tribal Governments 0 0 0

45 CFR 156.1230 No Health Health Care Services State, Local, and Tribal Governments 0 0 0

2013-11-21-05:00

0938-1214 201306-0938-011 0938
             
        "Issuer Reporting Requirements for Selecting a Cost-Sharing Reductions Reconciliation Methodology"
             
          
        
HHS provides qualified health plan (QHP) issuers two options for how to reconcile cost-sharing reduction (CSR) amounts at the end of each benefit year. This PRA establishes what data elements a QHP issuer must submit to HHS to inform the agency of which CSR reconciliation option the issuer chooses to be subject to for benefit year 2014. 2016-09-30-04:00 Active William Parham 4107864669 No Yes No 1200 13200 13200

Issuer Reporting Requirements for Selecting a Cost-Sharing Reductions Reconciliation Methodology No Health Health Care Services Private Sector 1200 13200 13200

2013-09-20-04:00

0938-1215 201308-0938-022 0938
             
        "Cooperative Agreement to Support Navigators in Federally-facilitated and State Partnership Exchanges"
             
          
        
On March 23, 2010, the President signed into law the Patient Protection and Affordable Care Act. On March 30, 2010, the Health Care and Education Reconciliation Act of 2010 was also signed into law. The two laws collectively are referred to as the Affordable Care Act. The Affordable Care Act creates State-based health insurance Exchanges, new competitive marketplaces where consumers and small businesses can purchase private health insurance. Consumers who access health insurance coverage through Exchanges will be able to receive direct assistance from Navigators authorized to help consumers through the registration, eligibility determination, and plan selection process as they enroll in the Exchanges. Section 1311(i) requires that an Exchange establish a Navigator program under which it awards grants to individuals or entities who satisfy the requirements to be Exchange Navigators. Navigators will assist consumers by providing education about and facilitating selection of qualified health plans (QHPs) within Exchanges, as well as other required duties. For Federally-facilitated Exchanges (FFE) and State Partnership Exchanges (SPEs), CMS will be awarding these grants. 2016-09-30-04:00 Active Jamaa Hill 301 492-4190 No Yes No 1848 308352 6491232

Navigator Annual Progress Report No Health Health Care Services Private Sector 264 6336 223872

Quarterly Progress Reports No Health Health Care Services Private Sector 1056 300432 6211392

Bi-Annual Prevention Fund Reports No Health Health Care Services State, Local, and Tribal Governments 528 1584 55968

2013-09-30-04:00

0938-1216 201308-0938-026 0938
             
        "State Health Insurance Exchange Security Incident Report"
             
          
        
As part of the privacy and security oversight of State Health Insurance Exchanges the States will be required to report security incidents include breaches of personally identifiable information (PII). This reporting will be made by completing and electronically submitting the State Health Insurance Exchange Security Incident Report (Incident Report), or providing identical information telephonically. 2014-03-31-04:00 Active William Parham 4107864669 No Yes No 936 234 0

Incident Reporting No Health Health Care Services
CMS-10496 STATE HEALTH INSURANCE EXCHANGE SECURITY INCIDENT REPORT Yes Yes Fillable Fileable Form and instruction CMS-10496_HIM_State_Incident_Report-508.pdf
State, Local, and Tribal Governments 936 234 0

2013-09-30-04:00

0938-1217 201312-0938-011 0938
             
        "Payment Collections Operations Contingency Plan  "
             
          
        
CMS will collect enrollment and payment information using a spreadsheet. This is an interim process. 2014-06-30-04:00 Active Jamaa Hill 301 492-4190 No Yes No 7875 52375 0

Payment Collections Operations Contingency Plan No Health Health Care Services
CMS-10515 SBM Isser Payment Report Yes Yes Fillable Fileable Form and instruction Copy of Enrollment and Payment Data Template 12 1 13v3.xlsx
Private Sector 575 9200 0

Monthly Data Reports No Health Health Care Services
CMS-10515 Copy of Enrollment and Payment Data Template Yes Yes Fillable Fileable Form and instruction CMS-10515 - Copy of Enrollment and Payment Data Template 12 1 13v3.xlsx
Private Sector 3450 41400 0

Monthly Data Submission Accuracy Certification Form No Health Health Care Services
CMS-10515 Enrollment and Payment Data Template Submission Accuracy Certification Form Yes Yes Fillable Printable Form and instruction Payment Data Submission Certification (2).docx
Private Sector 3450 575 0

Testing & Development No Health Health Care Services Private Sector 400 1200 0

2013-12-24-05:00

0938-1218 201312-0938-015 0938
             
        "Basic Health Program Report for Health Insurance Exchange Premium"
             
          
        
CMS is requesting that an information collection request to support the development of federal payment rates for the Basic Health Program (BHP) be processed under the emergency clearance process associated with Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.13(a)(2)(i). In accordance with Section 1331 of ACA, the BHP is federally funded by determining the amount of payments that the federal government would have made through premium tax credits (PTCs) and cost sharing reductions (CSRs) for people enrolled in BHP had they instead been enrolled in an Exchange. In order to calculate these amounts for each state, CMS needs the reference premiums for the second lowest cost silver plans (SLCSPs) in each geographic area in a state, as SLCSPs are a basic unit in the calculation of PTCs and CSRs under the Exchanges. Relatedly, the reference premiums for these SLCSPs are critical components in the BHP payment methodology in order to estimate what PTCs and CSRs would have been paid. Similarly, CMS also needs to collect reference premiums for the lowest cost bronze plans to appropriately account for CSR calculations for American Indians and Alaskan Natives. CMS recently determined that it does not have sufficient data from State Based Exchanges (SBEs) to determine the reference premiums for their SLCSPs and lowest cost bronze plans. Reference premiums are foundational inputs into the BHP payment methodology. 2014-07-31-04:00 Active Mitch Bryman Mitch.Bryman@cms.hhs.gov 410 786-5258 No Yes No 17 68 0

Basic Health Plan State Report for Health Insurance Exchange Premiums No Health Health Care Services
Yes No Printable Only Other BHP Disclosure Statement 11182013.doc CMS-10510 BHP State Report for Health Insurance Exchange Premiums Yes Yes Fillable Printable Form and instruction BHP State Report for Exchange Premiums 11-20-2013 final.xlsx
State, Local, and Tribal Governments 17 68 0

2014-01-06-05:00

0938-1219 201308-0938-006 0938
             
        "Medicaid Incentives for Prevention of Chronic Diseases Evaluation"
             
          
        
Section 4108 (a) (1) of the 2010 Affordable Care Act (ACA) established the Medicaid Incentive for Prevention of Chronic Disease program (MIPCD). This national demonstration awarded 10 grants to states to implement programs that provide incentives to Medicaid beneficiaries of all ages who participate in prevention programs and demonstrate changes in health risk and outcomes, including the adoption of healthy behaviors. Programs address at least one of the following prevention goals: tobacco cessation, controlling or reducing weight, lowering cholesterol, lowering blood pressure, and avoiding the onset of diabetes or in the case of a diabetic, improving the management of the condition. Programs are comprehensive, widely available, easily accessible, and based on relevant evidence-based research and resources. Under Section 4108 (d) of the Affordable Care Act, Health and Human Services Secretary through the Centers for Medicare and Medicaid Services (CMS) awarded a contract to Research Triangle Institute to conduct an independent assessment of these 10 State demonstration Grantees. This assessment will focus on evaluating:(A)the effect of the initiatives on the use of health care services by Medicaid beneficiaries participating in the program;(B)the extent to which special populations (adults with disabilities, adults with chronic illnesses, and children with special health care needs) are able to participate in the program; (C)the level of satisfaction of Medicaid beneficiaries with respect to the accessibility and quality of health care services provided through the program; and(D)the administrative costs incurred by State agencies that are responsible for administration of the program. To address these topics we will be conducting Site Visits, Stakeholder Interviews, Focus Groups, and a Beneficiary Survey. 2017-01-31-05:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No Yes No 4686 1836 0

Site Visit Interviews No Health Health Care Services
CMS-10477 Management staff interview protocol and consent No No Fillable Fileable Form and instruction Attachment_5c_SV_Management_Protocol_Consent_Form.pdf CMS-10477 Clinic staff interview protocol and consent No No Fillable Fileable Form and instruction Attachment_5g_SV Clinic_Protocol_Consent_Forms.pdf CMS-10477 State evaluator interview protocol and consent No No Fillable Fileable Form and instruction Attachment_5f_SV_Evaluator_Protocol_Consent Form.pdf CMS-10477 Staff educator interview protocol and consent No No Fillable Fileable Form and instruction Attachment_5e_SV Educator_Protocol_Consent_Forms.pdf CMS-10477 Recruitment staff interview protocol and consent No No Fillable Fileable Form and instruction Attachment_5d_SV_Recruiter_Protocol_Consent_Form.pdf
Private Sector 200 200 0

Stakeholder Interview No Health Health Care Services
CMS-10477 Stakeholder interview guide and consent form No No Fillable Fileable Form and instruction Attachment_7a_Interview Guide_Consent_Forms.pdf CMS-10477 Stakeholder interview appointment reminder No No Fillable Fileable Form and instruction Attachment_7b_Reminder_Text.pdf CMS-10477 Physician interview verbal consent script No No Fillable Fileable Form and instruction Attachment_2c_Consent_Form for Physicians.pdf CMS-10477 Stakeholder interview scheduling script No No Fillable Fileable Form and instruction Attachment_7c_Scheduling_Script.pdf
Private Sector 45 23 0

Focus Groups No Health Health Care Services
CMS-10477 Consent_Forms_Spanish_new_clean No Fillable Fileable Form and instruction Attachment_8e_Consent_Forms_Spanish_new_clean.docx CMS-10477 Focus group consent form No No Fillable Fileable Form and instruction Attachment_4e_Consent_Form_English_clean.docx CMS-10477 Participant contact release form for focus groups No No Fillable Fileable Form and instruction Attachment_4d_Participant_Contact_Release_Forms_English_clean.docx CMS-10477 Screener for focus group eligibility No No Fillable Fileable Form and instruction Attachment_4a_Focus Group_Screener_English_clean.docx CMS-10477 Participant_Contact_Release_Forms_Spanish_new_clean No Fillable Fileable Form and instruction Attachment_8d_Participant_Contact_Release_Forms_Spanish_new_clean.docx CMS-10477 Discussion guide for focus groups No No Fillable Fileable Form and instruction Attachment_4b_Round_1_and_2_Discussion_Guide.pdf CMS-10477 Screener_Spanish_new_clean No Fillable Fileable Form and instruction Attachment_8a_Screener_Spanish_new_clean.docx
Private Sector 880 613 0

Beneficiary Satisfaction Survey No Health Health Care Services
CMS-10477 CATI_Script_Spanish_new_clean No Fillable Fileable Form and instruction Attachment_9e_CATI_Script_Spanish_new_clean.docx CMS-10477 Survey_Spanish_new_clean No Fillable Fileable Form and instruction Attachment_9c_Survey_Spanish_new_clean.doc CMS-10477 Beneficiary survey questionnaire No No Fillable Fileable Form and instruction Attachment_6c_Survey_English_clean.docx CMS-10477 Beneficiary survey phone follow-up for non-responders No No Fillable Fileable Form and instruction Attachment_6e_Survey_Telephone_Follow-up_Script_English_clean.docx
Private Sector 3561 1000 0

2014-01-23-05:00

0938-1220 201307-0938-011 0938
             
        "Patient Protection and Affordable Care Act; Exchange Functions: Standards for Navigators and Non-Navigator Assistance Personnel"
             
          
        
Navigators as well as non-Navigator assistance personnel fulfilling the requirements of 45 CFR ?155.205(d) and (e) in Federally-facilitated Exchanges have to provide an attestation to the Exchange that they are not ineligible to serve as a Navigator or non-Navigator assistance personnel. In addition, Navigators and non-Navigator assistance project leads have to prepare and submit a plan for mitigating conflicts of interest during their term as a Navigator grantee or non-Navigator assistance personnel. This mitigation plan is only required on a per entity basis, not a per individual basis. Navigators will include attestation information within their grant application through previously approved OMB covered forms, and as such, the burden for Navigators providing this information is not calculated in this PRA. Navigators and non-Navigator assistance personnel are required to provide information to eligible consumers about the full range of QHP options and insurance affordability programs for which they may be eligible. A disclosure to the Exchange and each consumer receiving assistance, about certain non-prohibited conflicts of interest, are required by Navigators and non-Navigator assistance personnel. Prior to performing any Navigator or non-Navigator assistance personnel duties, individuals are required to register for training as a prerequisite to becoming certified. After their first year performing their required duties, they will be required to be recertified. Navigators and non-Navigator assistance personnel are required to maintain proof of their certification or recertification. 2017-01-31-05:00 Active Jamaa Hill 301 492-4190 No Yes No 45279 528678 0

Patient Protection and Affordable Care Act; Exchange Functions: Standards for Navigators and non-Navigator Assistance Personnel No Health Health Care Services Private Sector 45279 528678 0

2014-01-27-05:00

0938-1221 201402-0938-007 0938
             
        "Health Insurance Marketplace Consumer Experience Surveys: Enrollee Satisfaction Survey and Marketplace Survey Data Collection"
             
          
        
Section 1311(c)(4) of the ACA requires the Department of Health and Human Services (HHS) to develop an enrollee satisfaction survey system that assesses consumer experience with qualified health plans (QHPs) offered through an Exchange. It also requires public display of enrollee satisfaction information by the Exchange to allow individuals to easily compare enrollee satisfaction levels between comparable plans. CMS is developing, testing and implementing two surveys, a survey for adult enrollees in QHPs and a survey for health insurance Marketplace consumers. CMS is requesting approval for information collection associated with these surveys. 2017-02-28-05:00 Active Jamaa Hill 301 492-4190 No Yes No 668590 297670 0

English - Adult Qualified Health Plan Enrollee Experience Survey No Health Health Care Services
CMS-10488 English - Adult Qualified Health Plan Enrollee Experience Survey Yes Yes Fillable Fileable Form and instruction English Adult QHP Enrollee Experience Survey after OMB NCHS review_clean_2-5-14_CMS.docx
Private Sector 604240 271930 0

Marketplace Survey Data Collection No Health Health Care Services
CMS-10488 English - Marketplace Survey Yes Yes Fillable Fileable Form and instruction English Marketplace Survey after OMB NCHS review_clean_2-6-2014_CMS (2).docx
Private Sector 64350 25740 0

2014-02-12-05:00

0938-1222 201303-0938-016 0938
             
        "CAHPS Survey for Physician Quality Reporting"
             
          
        
The Physician Quality Reporting System (Physician Quality Reporting) is a reporting program that uses a combination of incentive payments and payment adjustments to promote reporting of quality information by eligible professionals. The program provides an incentive payment to practices with eligible professionals (identified on claims by their individual National Provider Identifier [NPI] and Tax Identification Number [TIN]) who satisfactorily report data on quality measures for covered Physician Fee Schedule (PFS) services furnished to Medicare Part B Fee-for-Service (FFS) beneficiaries (including Railroad Retirement Board and Medicare Secondary Payer). Beginning in 2015, the program also applies a payment adjustment to eligible professionals who do not satisfactorily report data on quality measures for covered professional services. The Physician Quality Reporting System is mandated by federal legislation. The Affordable Care Act makes a number of changes to the Physician Quality Reporting System, including authorizing incentive payments through 2014 and requiring a penalty, beginning in 2015, for eligible professionals who do not satisfactorily report. The Affordable Care Act also authorizes an additional 0.5 percent incentive for 2011 through 2014 for eligible professionals who satisfactorily report and more frequently than is required to qualify for or maintain board certification status participates in a Maintenance of Certification Program for a year and successfully completes a qualified Maintenance of Certification Program practice assessment for such year. 2017-02-28-05:00 Active Denise King Denise.King@cms.hhs.gov 410 786-1013 No Yes No 117300 39530 0

CAHPS Survey for Physician Quality Reporting No Health Public Health Monitoring
CMS-10450 CAHPS Suvery No No Fillable Fileable Form and instruction ._508 Attachment 1 Survey for PQRS OMB 2012-11-3.docx
Individuals or Households 117300 39530 0

2014-02-12-05:00

0945-0001 201302-0945-002 0945
             
        "HITECH Act Breach Notification"
             
          
        
The purpose of this media notification, which must be provided in addition to individual notification, is not to alert affected individuals of the breach. The purpose of media notification is to alert the public that a covered entity has experienced a breach. 2016-09-30-04:00 Active Sherrette Funn-Coleman 2026905683 Yes No No 7445930 321787 2857160

Individual Notice Written and E-mail Notice No Health Illness Prevention Individuals or Households 19000 9500 1710000

500 or more affected Individuals No Health Illness Prevention Individuals or Households 250 12500 0

Less than 500 affected individuals No Health Illness Prevention Individuals or Households 940 7520 0

Individual Notice substitute Notice No Health Illness Prevention Individuals or Households 660550 82569 0

Media Notice No Health Illness Prevention Individuals or Households 250 313 0

Notice to Secretary(notice for breaches affecting fewer than 500 individuals) No Health Illness Prevention Individuals or Households 18750 18750 0

Individual Notice--Substitute Notice (posting or publishing) No Health Illness Prevention Individuals or Households 1190 1190 571200

Individual Notice--Written and E-mail Notice (preparing and documenting notification) No Health Illness Prevention Individuals or Households 19000 9500 0

Individual Notice--Written and E-mail Notice (processing and sending) No Health Illness Prevention Individuals or Households 6707000 53656 0

Less than 500 Affected Individuals (investigating and documenting breach)affecting <10 individuals No Health Illness Prevention Individuals or Households 17810 71240 0

Individual Notice--Substitute Notice (setting up and staffing toll-free number) No Health Illness Prevention Individuals or Households 1190 55049 575960

2013-09-26-04:00

0945-0002 201301-0945-001 0945
             
        "Complaint Forms for Discrimination; Health Information Privacy Complaints"
             
          
        
Individuals may file written complaints with the Office for Civil Rights when they believe they have been discriminated against by programs or entities that receive Federal financial assistance from HHS or if they believe that, on or after April 14, 2003, their right to the privacy of protected health information has been violated. The complaint forms in this PRA submission provide the basic information needed by OCR to allow initial processing of such complaints. 2015-12-31-05:00 Active Sherrette Funn-Coleman 2026905683 No No No 13779 10335 0

Complaint Forms for Discrimination; Health Information Privacy Complaints No Health Health Care Services Individuals or Households 3493 2620 0

Health Information Privacy Complaint Form No Health Illness Prevention Individuals or Households 10286 7715 0

2013-01-17-05:00

0945-0003 201309-0945-001 0945
             
        "Standards for Privacy of Individually Identifiable Health Information and Supporting Regulations at 45 CFR Parts 160 and 164"
             
          
        
The individually identifiable health information collected is used by patients and by more than 500,000 covered entities affected by the HIPAA Privacy Rule. The information is routinely used by covered entities for treatment, payment, and health care operations. In addition, the information is used for specified public policy purposes, including research, public health, and as required by other laws. 2017-01-31-05:00 Active Sherrette Funn-Coleman 2026905683 No No No 836457025 32762920 0

Process for Requesting Exception Determinations (states or persons) No Health Health Care Services State, Local, and Tribal Governments 1 16 0

Uses and Disclosures-Organizational Requirement No Health Health Care Services State, Local, and Tribal Governments 700000 58333 0

Uses and Disclosures for which Individual authorization is required No Health Health Care Services State, Local, and Tribal Governments 700000 700000 0

Uses and Disclosures for which consent individual authorization or opportunity to agree or Object is not required No Health Health Care Services State, Local, and Tribal Governments 113524 9460 0

Notice of privacy Practices for Protected Health Information/health plan by distibution by paper mail No Health Health Care Services State, Local, and Tribal Governments 100000000 416667 0

Notice of Privacy Practices for Protected Health Information (health care providers - dissemination/acknowledgement No Health Health Care Services State, Local, and Tribal Governments 613000000 30650000 0

Notice of Privacy Practices for Protected Health Information (health care providers - acknowledgement) No Health Health Care Services State, Local, and Tribal Governments 0 0 0

Rights to Request Privacy Protection for Protected Health Information/distribution by electronic mail No Health Health Care Services State, Local, and Tribal Governments 100000000 278333 0

Access of Individuals to Protected Health Information (disclosures) No Health Health Care Services State, Local, and Tribal Governments 150000 7500 0

Amendment of Protected Health Information (requests) No Health Health Care Services State, Local, and Tribal Governments 150000 7500 0

Amendment of Protected Health Information (denials) No Health Health Care Services State, Local, and Tribal Governments 50000 2500 0

Accounting for Disclosures of Protected Health Information No Health Health Care Services State, Local, and Tribal Governments 70000 5833 0

Documentation of Security Rule Policies and Procedures and Administrative safeguards business associates No Health Public Health Monitoring Individuals or Households 300000 350000 0

Rights to request privacy protection for protected health information No Health Illness Prevention Private Sector 150000 7500 0

Dissemination of Notice of Privacy Practices for Protected Health Information(health Plans) No Health Illness Prevention Private Sector 20000000 66667 0

Business Associates Needing to establish or Modify Business Associate Agreements with Subcontrractors No Health Illness Prevention Private Sector 375000 125000 0

Revision of Notice of Privacy Practices for Protected Health Information (drafting revised language health plan No Health Illness Prevention Private Sector 1500 167 0

Revison of Notice of Privacy Practices (providers) No Health Illness Prevention Private Sector 697000 77444 0

2014-01-24-05:00

0945-0004 201305-0945-001 0945
             
        "Health Insurance Reform Security Standards - Final Rule"
             
          
        
This final rule adopts standards for the security of electronic protected health information to be implemented by health plans, health care clearinghouses and certain health care providers. The use of the security standards will improve the Medicare and Medicaid programs, and other Federal health programs, and private health programs, and the effectiveness and efficiency of the health care industry in general by establihsing a level of protection for certain electronic health information. 2016-05-31-04:00 Active William Parham 4107864669 No No No 4000000 64539263 0

Health Insurance Reform Security Standards - Final Rule No Health Health Care Services Private Sector 4000000 64539263 0

2013-05-22-04:00

0945-0005 201305-0945-002 0945
             
        "HIPAA Audit Review Survey"
             
          
        
The information, opinions, and comments collected using the information collection will be used to produce recommendations for improving the HIPAA Audit program. The HIPAA Audit program is mandated under Section 13411 of the HITECH Act (42 U.S.C. 17940): "The Secretary shall provide for periodic audits to ensure that covered entities and business associates that are subject to the requirements of this subtitle and subparts C and E of part 164 of title 45, Code of Federal Regulations, as such provisions are in effect as of the date of enactment of this Act, comply with such requirements. 2016-07-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 115 52 0

Covered Entity Privacy and Security Officers No Health Illness Prevention Private Sector 115 52 0

2013-07-02-04:00

0945-0006 201310-0945-001 0945
             
        "OCR Pre-granted Automation Project"
             
          
        
Recipients of HHS funds must review their policies/practices and submit documents to demonstrate compliance with the Civil Rights Requirements of Title VI of the Civil Rights Act of 1964, Section 504 of the Rehab Act of 1973 and the Age Discrimination Act 1975. 2014-03-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 2900 23200 0

OCR Pre-granted Automation Project No Health Health Care Services
1 0990-0243-Civil Rights Infomation Request Form RevDS8-9-10[2] Yes Yes Fillable Fileable Form 0990-0243-Civil Rights Infomation Request Form RevDS8-9-10[2].doc
Private Sector 2900 23200 0

2013-10-31-04:00

0955-0001 201309-0955-001 0955
             
        "Consumer Survey of Attitudes Toward the Privacy and Security Aspects of Electronic Health Records and Electronic Health Information Exchange"
             
          
        
The widespread use of electronic health records and electronic health information exchange promise an array of potential benefits for individuals and the U.S. health care system, such as through improved health care quality, safety, and efficiency. At the same time, this environment also poses new challenges and opportunities for protecting health information. Health IT and electronic health information exchange may also provide individuals with new, more effective methods to engage with their health care providers and affect how their health information may be exchanged. 2015-07-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 2033 508 0

Pretest Survey No Health Illness Prevention Individuals or Households 33 8 0

Main Survey No Health Immunization Management Individuals or Households 2000 500 0

2013-09-30-04:00

0955-0002 201211-0955-001 0955
             
        "Facts for Consumers About Health"
             
          
        
The Obama administration's domestic healthcare overhaul agenda and stimulus plan directly impacts and supports the mandate for The Office of the National Coordinator for Health Information Technology (ONC), a division of the Department of Health and Human Services (HHS). That mandate is to provide leadership for the strategic development and nationwide implementation for interoperable health information technology (health IT) by 2014. 2016-01-31-05:00 Active Sherrette Funn-Coleman 2026905683 Yes No No 156 104 0

Individuals Screened/Coginitive testing No Health Consumer Health and Safety Individuals or Households 104 26 0

Participants selected No Health Consumer Health and Safety Individuals or Households 52 78 0

2013-01-08-05:00

0955-0003 201208-0955-003 0955
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (HITRC)"
             
          
        
This collection of information is necessary to enable the Agency to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the Agency's programs. 2014-10-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 4158 1041 0

Regional Extension Center staff No Health Illness Prevention Individuals or Households 207 35 0

Participant Self-Identification Information No Health Illness Prevention
1 User Self-ID Registration Questions No No Fillable Printable Form Cornell Planning Room.docx
Individuals or Households 175 175 0

KSN Annual Feedback Survey Year 3 No Health Illness Prevention Private Sector 367 77 0

HITRC Training Three Month Survey No Health Illness Prevention Federal Government 825 28 0

HITRC Training Focus Groups No Health Illness Prevention Individuals or Households 150 113 0

Survey to Evaluate the Use of HITRC Tool, Care Transition Summary Toolkit, by REC No Health Illness Prevention Private Sector 1240 207 0

KSN Annual Feedback Survey Year 3 No Health Illness Prevention Individuals or Households 326 38 0

2012-08-27-04:00

0955-0004 201208-0955-004 0955
             
        "Evaluation of the IT Professionals in Health Care Workforce Program: University-Based Training"
             
          
        
This OMB package is for approval of the baseline and follow-up surveys of university students. The baseline and follow-up community college student surveys, course evaluation forms, focus group protocols, and faculty survey received approval as part of a previously submitted OMB package. 2014-08-31-04:00 Active Sherrette Funn-Coleman 2026905683 Yes No No 1268 422 0

Students enrolled in University-Based Workforce program(Baseline survey) No Health Consumer Health and Safety Individuals or Households 634 211 0

Students enrolled in university-based Workforce program(Follow-up survey) No Health Consumer Health and Safety Individuals or Households 634 211 0

2012-08-27-04:00

0955-0005 201208-0955-005 0955
             
        "Comprehensive Communication Campaign for HITECH ACT"
             
          
        
ONC requests OMB approval for a generic clearance for collecting information through a variety of research methods for developing and testing communications involving health information technology and health information privacy. This information will be used to assess the need for communications on specific topics and to assist in the development and modification of communication messages. ONC intends to utilize best practices for effective health communication research set forth by other DHHS agencies such as the National Cancer Institute. 2014-07-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 34366 6928 0

Conduct Focus Groups to Test Messages and Materials No Health Illness Prevention Individuals or Households 4352 1088 0

Conduct Cognitive Testing of Test Survey Questions No Health Illness Prevention Individuals or Households 25 38 0

mHealth focus groups No Health Illness Prevention Individuals or Households 96 60 0

eConsent surveys No Health Illness Prevention Individuals or Households 2800 233 0

Survey Respondents No Health Illness Prevention Individuals or Households 2800 233 0

eConsent Administer Focus Group Sessions Across Patient Population No Health Illness Prevention Individuals or Households 50 75 0

mHealth Privacy and Security Consumer Research Focus Group No Health Illness Prevention Individuals or Households 288 624 0

Communication Testing for Comprehensive Communication Campaign for HITECH Act No Health Illness Prevention Individuals or Households 297 99 0

Provider Surveys No Health Illness Prevention Individuals or Households 4400 433 0

Cognitive Testing for Consumer Survey No Health Illness Prevention Individuals or Households 25 38 0

Communications Testing for Comprehensive Communication Campaign for HITECH Act - Consumer Survey Focus Group No Health Health Care Services State, Local, and Tribal Governments 10270 1166 0

National Test Bed Pilot Survey No Health Health Care Services Private Sector 100 200 0

Vendor No Health Illness Prevention Private Sector 100 8 0

EHR Vendor No Health Illness Prevention Private Sector 100 8 0

2012-08-27-04:00

0955-0006 201208-0955-006 0955
             
        "ARRA Section 3013 State Health Information Exchange Cooperative Agreement Program: State Plans"
             
          
        
States and QSDEs will be required to submit annual update to the State Plans reflecting updates in legal, policy, or technical infrastructure changes, as well as expanded content on sustainability and business planning for the HIE services fostered through the cooperative agreement, evaluation of the project, and alignment with other Federal programs authorized in HITECH. ONC will issue future PINs to provide additional guidance to States and QSDEs on the annual updates to Plan content areas needed. Annual updates to the plan are required one-year from the approval date of the State Plan. 2014-03-31-04:00 Active Sherrette Funn-Coleman 2026905683 Yes No No 112 215113 0

State Plans Strategic Operational No Health Consumer Health and Safety State, Local, and Tribal Governments 56 187113 0

Subsequent updates to the State Plan No Health Consumer Health and Safety State, Local, and Tribal Governments 56 28000 0

2012-08-27-04:00

0955-0007 201208-0955-007 0955
             
        "Evaluation of the IT Professionals in Health Care "
             
          
        
This evaluation is designed to contribute to a comprehensive understanding of the planning, implementation, and effectiveness of the Workforce Grant Program. The evaluation will determine how the Workforce Grant Program has contributed to the development of comprehensive, integrated health IT training programs across community colleges, universities, and other programs. 2014-03-31-04:00 Active Sherrette Funn-Coleman 2026905683 Yes No No 1871 968 0

Students enrolled in Workforce program(webbased student baseline survey) No Health Public Health Monitoring Individuals or Households 1233 411 0

Students enrolled in workforce (Focus Groupsw/ students) No Health Public Health Monitoring Individuals or Households 256 384 0

Instructors from Workforce program(Focus groups w/faculty) No Health Public Health Monitoring Individuals or Households 50 75 0

Competency exam takers not enrolled in workforce program(Fous groups w/exam takers) No Health Public Health Monitoring Individuals or Households 32 48 0

Instructors from Workforce program(web-based faculty survey) No Health Public Health Monitoring Individuals or Households 300 50 0

2012-08-27-04:00

0955-0008 201208-0955-008 0955
             
        "ARRA Section 3013 State Health Information Exchange Cooperative Agreement Program: Performance Measures and Program Progress Report"
             
          
        
The purpose of the program progress report collection is to collect regular information on the project progress of the States and QSDEs to enable ONC program and grants management staff to monitor progress, ensure appropriate and efficient use of funds, and gather data from all states and QSDEs that can be aggregated to inform ONC on national progress towards health information exchange goals. States and QSDEs submitting the reports will be able to document and attest to program activities. 2014-02-28-05:00 Active Sherrette Funn-Coleman 2026905683 Yes No No 224 1680 0

State Government or Qualified State- Full biannual report No Health Consumer Health and Safety Individuals or Households 112 1344 0

State Government or Qualified State - Partial progress report update on interim No Health Consumer Health and Safety Individuals or Households 112 336 0

2012-08-27-04:00

0955-0009 201208-0955-009 0955
             
        "Regional Extension Center Cooperative Agreement Program  (CRM Tool)"
             
          
        
The data collection will be used by ONC to evaluate program performance of each Regional Extension Center and track monetary draw downs for Core funding Direct Assistance allocation. Each Regional Center will have a proposed target number for priority primary care providers that they will help with EHR adoption and eventually meaningful use within their service area. 2014-02-28-05:00 Active Sherrette Funn-Coleman 2026905683 Yes No No 2400 3600 0

Regional Extenion Center No Health Illness Prevention Private Sector 720 1080 0

Community College Consortia No Health Public Health Monitoring Private Sector 1680 2520 0

2012-08-27-04:00

0955-0013 201209-0955-001 0955
             
        "Permanent Certification Program for Health Information Technology"
             
          
        
The information collected will be used to assess the qualifications and abilities of accreditation organizations to become the ONC-AA under the permanent certification program. The application process will be used to assess the qualifications and abilities of applicants for ONC-ACB status under the permanent certification program. ONC will use the contact information provided for an applicant's authorized representative to communicate and correspond with the applicant about the application. ONC will continue to use the authorized representative's contact information to communicate and correspond with the applicant if the applicant becomes an ONC-ACB 2014-07-31-04:00 Active Sherrette Funn-Coleman 2026905683 Yes No No 332 332 0

Applicant No Health Consumer Health and Safety Federal Government 6 6 0

Acreditation Organization No Health Consumer Health and Safety Individuals or Households 2 2 0

ONC-ACB Certification Results No Health Consumer Health and Safety Individuals or Households 312 312 0

Surveillance Plan and Results No Health Consumer Health and Safety Federal Government 12 12 0

2012-09-19-04:00

0955-0014 201301-0955-001 0955
             
        "National Survey on Health Information Exchange in Clinical Laboratories"
             
          
        
The Office of the National Coordinator for Health Information Technology's (ONC) Office of Economic Analysis, Evaluation, and Modeling in the Department of Health & Human Services (HHS) requests Office of Management and Budget (OMB) approval to conduct a national survey of clinical laboratories to assess laboratory information exchange capacity, as part of the evaluation of the State Health Information Exchange (HIE) Cooperative Agreement Program. The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 seeks to improve American health care delivery and patient care through an unprecedented investment in health information technology. ONC is the chief federal entity charged with coordinating nationwide efforts to implement a health IT infrastructure to enable the electronic use and exchange of health information. 2015-12-31-05:00 Active Sherrette Funn-Coleman 2026905683 Yes No No 4692 1499 0

Hospital -Based Laboratories No Health Illness Prevention State, Local, and Tribal Governments 2729 910 0

Independent Laboratories No Health Illness Prevention State, Local, and Tribal Governments 1963 589 0

2013-01-18-05:00

0970-0004 201111-0970-005 0970
             
        "Annual Statistical Report on Children in Foster Homes and in Families Receiving Payments in Excess of the Poverty Income Level from a State Program"
             
          
        
DHHS is required to collect these data under section 1124 of Title I of the Elementary and Secondary Education Act, as amended by PL 103-382. The data are used by the U.S. Department of Education for allocation of funds for programs to aid disadvantaged elementary and secondary students. Respondents include various components of State Human Service agencies. 2014-12-31-05:00 Active Robert Sargis 2026907275 No No No 52 13746 0

Annual Statistical Report on Children in Foster Homes and in Families Receiving Payments in Excess of the Poverty Income Level from a State Program No Community and Social Services Social Services State, Local, and Tribal Governments 52 13746 0

2011-12-28-05:00

0970-0017 201105-0970-002 0970
             
        "State Plan for Child Support Collection and Establishment of Paternity Under Title IV-D of the Social Security Act"
             
          
        
The State plan preprint and amendments serve as a contract with OCSE in outlining the activities the state will perform as required by law in order for states to receive federal funds to meet the costs of these activities. The affected public is comprised of states receiving funds. The information collected on the State plan pages is necessary to enable OCSE to determine whether each State and Territory has a IV-D State plan that meets the requirements in title IV-D of the Social Security Act and implementing regulations. 2014-07-31-04:00 Active Robert Sargis 2026907275 No No No 864 324 0

OCSE-100 No Community and Social Services Social Services
OCSE-100 State Plan Yes Yes Fillable Fileable Form and instruction Attachment II OCSE-100 State Plan Preprint Pages.doc
State, Local, and Tribal Governments 432 216 0

OCSE-21-U4 No Community and Social Services Social Services
OCSE-21-U4 Tranmittal Yes Yes Fillable Fileable Form and instruction Attachment III OCSE 21-U4 Transmittal Form.doc
State, Local, and Tribal Governments 432 108 0

2011-07-24-04:00

0970-0030 201108-0970-003 0970
             
        "Refugee Resettlement Program Estimates:  CMA"
             
          
        
The ORR-1 (Refugee Resettlement Program Estimates: CMA) allows ORR to obtain budget estimates for reimburseable costs from States at the beginning of the fiscal year. The form serves as the formal application for reimbursement for the costs of CMA (Cash/Medical/administration) for the Federally funded but State-administered Refugee Program. 2014-10-31-04:00 Active Robert Sargis 2026907275 No No No 48 29 0

Refugee Resettlement Program Estimates: CMA No Community and Social Services Social Services
ORR-1 Cash and Medical Assistance Estimates Yes Yes Fillable Printable Form and instruction ORR-1.xlsx
State, Local, and Tribal Governments 48 29 0

2011-10-12-04:00

0970-0033 201205-0970-004 0970
             
        "Annual Survey of Refugees"
             
          
        
The Annual survey of Refugees is conducted each Fall by a contractor. Approximately 2,000 refugee families are interviewed via telephone with questions relating to employment, English language skills and training, occupational training, education, and welfare utilization. 2016-01-31-05:00 Active Robert Sargis 2026907275 No No No 5000 1667 0

Survey Instrument No Community and Social Services Social Services
1 Annual Survey Yes Yes Fillable Fileable Form and instruction Questionnaire for OMB - English FINAL 3-14-12.pdf No No Fillable Printable Other HHSP23320110005YC-Fully executed contract.pdf
Individuals or Households 2500 1567 0

Request for Participation Letter No Community and Social Services Community and Regional Development Individuals or Households 2500 100 0

2013-01-18-05:00

0970-0034 201306-0970-001 0970
             
        "ORR-3 Refugee and Entrant Unaccompanied Minor Placement Report /ORR-4 Refugee and Entrant Unaccompanied Minor Placement Report"
             
          
        
The placement form is submitted by the local agency upon initial placement of the child and whenever there is a change in the child's status, including termination from the program. The progress report is required annually to indicate the child's progress towards goals in the child's case plan. 2016-08-31-04:00 Active Robert Sargis 2026907275 No No No 2910 2959 0

Title ORR-3 The Refugee Unaccompanied Minor Placement Report No Community and Social Services Social Services
ORR-3 Status Added Yes Yes Fillable Printable Form Final ORR-3 w U status added 052313.xls
State, Local, and Tribal Governments 1125 281 0

Title ORR-4 Regugee and Entrant Unaccompanied Minor Progress Report No Community and Social Services Social Services
ORR-4 Status Receipient Yes Yes Fillable Printable Form Final ORR-4 w U Status Recipient 052313.xls
State, Local, and Tribal Governments 1785 2678 0

2013-08-19-04:00

0970-0036 201210-0970-004 0970
             
        "ORR-6 Trimester Performance Report"
             
          
        
The Quarterly Performance Report is required from each State participating in the Refugee Resettlement program. On the form, the State reports its results for employment, training, cash assistance, and health programs for the previous quarter. 2015-10-31-04:00 Active Robert Sargis 2026907275 No No No 150 581 0

Quarterly Performance Report No Community and Social Services Social Services
1 Schedule A Yes Yes Fillable Printable Form ORR-6 SCHEDULE A Narrative.doc 1 Schedule C Yes Yes Fillable Printable Form ORR-6 Schedule C.xls 1 Schedule B Yes Yes Fillable Printable Form ORR-6 Schedule B.xls 1 Annual Service Plan Yes Yes Fillable Printable Form ORR-6 Annual Services Plan.docx
State, Local, and Tribal Governments 150 581 0

2012-12-14-05:00

0970-0037 201304-0970-009 0970
             
        "LIHEAP Quarterly Allocation Estimates, Form ACF-535"
             
          
        
The data collected will be used to determine the amount of LIHEAP funds issued quarterly to LIHEAP grantees and will be used to determine the amount of apportionment requests to OMB. 2014-09-30-04:00 Active Robert Sargis 2026907275 No No No 55 14 0

LIHEAP Quarterly Allocation Estimates No Community and Social Services Social Services
ACF-535 Quarterly Allocation Estimates Yes Yes Fillable Printable Form and instruction acf535.xls
State, Local, and Tribal Governments 55 14 0

2013-05-31-04:00

0970-0043 201203-0970-007 0970
             
        "Refugee Data Submission Sytstem for Formual Funds Allocations"
             
          
        
The Refugee State of Origin Report identifies the number of secondary migrants into each State from the refugee's State of initial resettlement. Each State identifies social security numbers issued in another State. These totals reflect in-migration into that State. From examination of the ORR-11s of other States, ORR is able to determine the out-migration into other States. Both in-migration and out-migration are added to derive the total gain or loss for each State. In this manner, ORR is able to adjust refugee arrival totals for secondary migration. 2015-07-31-04:00 Active Robert Sargis 2026907275 No No No 150 1000 0

Secondary Migrant File for Formula Funds Allocations No Community and Social Services Social Services State, Local, and Tribal Governments 50 334 0

Asylee File for Funds Allocation No Community and Social Services Social Services State, Local, and Tribal Governments 50 333 0

Entrant File for Formual Funds Allocations No Community and Social Services Social Services State, Local, and Tribal Governments 50 333 0

2012-07-06-04:00

0970-0060 201304-0970-010 0970
             
        "Low Income Home Energy Assistance Program (LIHEAP) Household Report"
             
          
        
The data are needed to comply with statutory requirements and Congressional requests for data under the Human Services Amendments of 1994 (Pub. Law 103-252). The data will be included as part of the Department's annual LIHEAP report to Congress. The data are also used to measure LIHEAP targeting performance under the Government Performance Results Act of 1993. The respondents include states, direct-grant Indian tribes and tribal organizations, and insular areas which receive LIHEAP grants from the Department. The reports provide basic oversight data. 2014-10-31-04:00 Active Robert Sargis 2026907275 No No No 268 2140 0

Long Format for Applicants No Community and Social Services Social Services
1 Long Format for Applicant Yes Yes Fillable Printable Form and instruction hhsrptst12_long form.xls
State, Local, and Tribal Governments 52 676 0

Long Format for Assisted No Community and Social Services Social Services
1 LIHEAP Long Format for Assisted Yes Yes Fillable Printable Form and instruction hhsrptst12_long form.xls
State, Local, and Tribal Governments 52 1300 0

Short Format No Community and Social Services Social Services
1 LIHEAP Household Report-Short Form Yes Yes Fillable Printable Form and instruction hhsrptin12.xls
State, Local, and Tribal Governments 164 164 0

2013-05-31-04:00

0970-0075 201012-0970-008 0970
             
        "Application Requirements for the Low Income Home Energy Assistance Program (LIHEAP) Model Plan"
             
          
        
The data collected will be used as the application for LIHEAP block grant funding to determine the state, tribal and territorial grantees of LIHEAP funds for each fiscal year in order to carry out the requirements of Section 2605(b) of the LIHEAP statute. 2014-04-30-04:00 Active Robert Sargis 2026907275 No No No 432 336 0

LIHEAP Abbreviated Model Plan No Community and Social Services Social Services
1 Abbreviated Model Plan Yes Yes Fillable Printable Form and instruction OMB-modelabr2010.doc
State, Local, and Tribal Governments 144 48 0

LIHEAP Detailed Model Plan No Community and Social Services Social Services
1 Detailed Model Plan Yes Yes Fillable Printable Form and instruction OMB-Modelful2010.doc
State, Local, and Tribal Governments 72 72 0

LIHEAP Program Integrity Assessment and Plan No Community and Social Services Social Services
1 Integrety Assessment Yes Yes Fillable Printable Form and instruction program_integritysupplementOMB12_11082010.doc
State, Local, and Tribal Governments 216 216 0

2011-04-25-04:00

0970-0076 201304-0970-008 0970
             
        "Low Income Home Energy Assistance Program (LIHEAP) Grantee Survey"
             
          
        
OCS collects and reports on state estimates of sources and uses of LIHEAP funding, average household LIHEAP benefits, and the maximum household income cutoffs used for LIHEAP assistance. The survey data are: (1) displayed in tables in the Secretary's Annual LIHEAP Report to Congress, (2) used to respond to inquiries from Congress, OMB, and the White House, and (3) disseminated through copies of the Secretary's Annual LIHEAP Report to Congress. 2014-04-30-04:00 Active Robert Sargis 2026907275 No No No 51 179 0

Low Income Home Energy Assistance Program (LIHEAP) Grantee Survey No Community and Social Services Social Services
1 LIHEAP GRANTEE SURVEY Yes Yes Fillable Fileable Form Sample survey10$.xls
State, Local, and Tribal Governments 51 179 0

2013-05-31-04:00

0970-0085 201312-0970-002 0970
             
        "Provision of Services in Interstate Child Support Enforcement: Standard Forms"
             
          
        
All states have enacted the Uniform Interstate Family Support Act, as required by Pub. L. 104-193, the Personal Responsibility and Work Opportunity Reconciliation Act of 1996. Each state's UIFSA law authorizes the use of federally authorized forms promulgated in connection with the IV-D child support enforcement program and mandated substantial compliance with those forms. 45 CFR 303.7 also requires IV-D agencies to transmit child support case information on standard interstate forms when referring cases to other states for processing. These standard forms have resulted in substantial improvement. 2017-02-28-05:00 Active Robert Sargis 2026907275 No No No 3916458 676682 0

Uniform Support Petition No Community and Social Services Social Services
1 Uniform Petition Yes Yes Fillable Printable Form and instruction OMB-0970-0085-U_Uniform_Support_Petition.pdf
State, Local, and Tribal Governments 628290 50263 0

Transmittal #3 No Community and Social Services Social Services
1 Tranmittal 3 Yes Yes Fillable Printable Form and instruction OMB-0970-0085-T3_Transmittal_3.pdf
State, Local, and Tribal Governments 52380 4190 0

Transmittal 2 No Community and Social Services Social Services
1 Tranmittal 2 Yes Yes Fillable Printable Form and instruction OMB-0970-0085-T2_Transmittal_2.pdf
State, Local, and Tribal Governments 785376 62830 0

Transmittal 1 No Community and Social Services Social Services
1 Transmittal 1 Yes Yes Fillable Printable Form and instruction OMB-0970-0085-T1_Transmittal_1.pdf
State, Local, and Tribal Governments 1047168 261792 0

Registration Statement No Community and Social Services Social Services
1 Registration Statement Yes Yes Fillable Printable Form and instruction OMB-0970-0085-R_Registration.pdf
State, Local, and Tribal Governments 418878 33510 0

Contolling Order No Community and Social Services Social Services
1 Controlling Order Yes Yes Fillable Printable Form and instruction OMB-0970-0085_Controlling_Order.pdf
State, Local, and Tribal Governments 20952 1676 0

Locate Data Sheet No Community and Social Services Social Services
1 Locate Data Sheet Yes Yes Fillable Printable Form and instruction Locate Data Sheet.pdf
State, Local, and Tribal Governments 20952 1676 0

General Testimony No Community and Social Services Social Services
1 General Testimony Yes Yes Fillable Fileable Form and instruction OMB-0970-0085-G_General_Testimony.pdf
State, Local, and Tribal Governments 628290 207336 0

Affidavit / Paternity No Community and Social Services Social Services
1 Affidavit Yes Yes Fillable Printable Form and instruction Affidavit inSupport of Establishing Paternity.pdf
State, Local, and Tribal Governments 314172 53409 0

2014-02-06-05:00

0970-0106 201304-0970-011 0970
             
        "Low Income Home Energy Assistance Program (LIHEAP) Carryout and Reallotment Report"
             
          
        
The data collected will be used to determine the amount of LIHEAP funds to be held available for the following fiscal year and the amount, if any, available for reallotment to other grantees in order to carry out the requirements of Section 2607(b) of the LIHEAP statute. 2014-09-30-04:00 Active Robert Sargis 2026907275 No No No 192 576 0

Low Income Home Energy Assistance Program (LIHEAP) Carryout and Reallotment Report No Community and Social Services Social Services
1 LIHEAP Carryover and Reallotment Report Yes Yes Fillable Printable Form and instruction OMB-C&R INSTR & FormFY11.doc
State, Local, and Tribal Governments 192 576 0

2013-05-31-04:00

0970-0114 201303-0970-005 0970
             
        "Child Care and Development Fund Plan for States/Territories for FY 2014-2015"
             
          
        
This Plan describes the CCDF program to be conducted by the State for the period 10/1/2012 to 9/30/2013. As provided for in the applicable statues and regulations, the Lead Agency has the flexibility to modify this program at any time, including changing the options selected or described herein. The official text of the applicable laws and regulations govern, and the Lead Agency acknowledges its responsibility to adhere to them regardless of the fact that, for purposes of simplicity and clairity, the specific provisions printed herein are sometimes paraphrases of, or excerpts and incomplete quotations from, the full text. 2016-05-31-04:00 Active Robert Sargis 2026907275 No No No 28 4550 0

Child Care and Development Fund Plan for States/Territories for FY 2012-2013 No Community and Social Services Social Services
1 Plan Preprint Yes Yes Fillable Fileable Form and instruction FY2012-2013 Plan Preprint and Instructions for States and Territories.pdf 2 (0970-0114) State_Territories_FY2012-2013 CCDF Plan 6-1-11(final) Yes Yes Fillable Fileable Form and instruction (0970-0114) State_Territories_FY2012-2013 CCDF Plan 6-1-11(final).docx
State, Local, and Tribal Governments 0 0 0

CCDF Plan for States/Territories 2014-2015 No Community and Social Services Social Services
ACF-118 CCDF Plan for States/Territories FY 2014-2015 Yes Yes Fillable Fileable Form and instruction FY 2014 - 2015 Plan Preprint Purple Version Feb 2013 Edition-1.pdf
State, Local, and Tribal Governments 28 4550 0

2013-05-02-04:00

0970-0121 201304-0970-007 0970
             
        "Low Income Home Energy Assistance (LIHEAP) Leveraging Report"
             
          
        
The data collected will be used to determine the amount of nonfederal home energy resources that LIHEAP grantees have leveraged for low income households in carrying out the provisions of Section 96.87 of the LIHEAP regulations. 2015-03-31-04:00 Active Robert Sargis 2026907275 No No No 70 2660 0

Low Income Home Energy Assistance (LIHEAP) Leveraging Report No Community and Social Services Social Services
1 LIHEAP Leveraging Report Yes Yes Fillable Fileable Form OMB-levfrm2009[1].doc
State, Local, and Tribal Governments 70 2660 0

2013-05-30-04:00

0970-0123 201311-0970-001 0970
             
        "National Extranet Optimized Runaway and Homeless Youth Management Information System (NEORHYMIS)"
             
          
        
The Runaway and Homeless Youth Act (RHYA), as amended by Public Law 106-71 (42 U.S.C. 5701 et seq.), mandates that the Department of Health and Human Services (HHS) report regularly to Congress on the status of HHS-funded programs serving runaway and homeless youth. Organizations funded under the Runaway and Homeless Youth (RHY) program are required by Section 312 (b)(7) of the Statute to meet several data collection and reporting requirements. These requirements include maintenance of client statistical records and submission of annual program reports regarding the characteristics of the youth and families served and the services provided to them. (Attached as Exhibit 1 are the relevant sections of the statute and regulation mandating the collection of information.) The October, 2003, reauthorization of the Act maintained the requirements as described in the standing legislation. 2016-12-31-05:00 Active Robert Sargis 2026907275 No No No 963796 31622 0

BCP Entrance Report No Community and Social Services Social Services
1 BCP Entrance Report Yes Yes Fillable Printable Form and instruction BCP Entrance.doc
Private Sector 37881 4735 0

BCP Exit Report No Community and Social Services Social Services
1 BCP Exit Report Yes Yes Fillable Printable Form and instruction BCP Exit.doc
Private Sector 37881 4735 0

Brief Contacts No Community and Social Services Social Services
1 Brief Contact Yes Yes Fillable Printable Form and instruction Brief Contact.doc
Private Sector 80478 4024 0

Turnaways No Community and Social Services Social Services
1 Turnaways and Watch List Yes Yes Fillable Printable Form and instruction TLP Turnaway and Waitlist.doc
Private Sector 17358 868 0

Street Outreach No Community and Social Services Social Services
1 Street Outreach Yes Yes Fillable Printable Form and instruction SOP Contact.doc
Private Sector 781080 15622 0

Data Transfer No Community and Social Services Social Services
1 Turnaway and Wait List Yes Yes Fillable Printable Form and instruction TLP Turnaway and Waitlist.doc
Private Sector 1328 664 0

TLP Exit Report No Community and Social Services Social Services
1 TLP Exit Report Yes Yes Fillable Printable Form and instruction TLP Exit.doc
Private Sector 3895 487 0

TLP Entrance Report No Community and Social Services Social Services
1 TLP Entrance Report Yes Yes Fillable Printable Form and instruction TLP Entrance.doc
Private Sector 3895 487 0

2013-12-27-05:00

0970-0139 201208-0970-005 0970
             
        "ACF Uniform Project Description (UPD)"
             
          
        
The UPD is used by ACF to solicit project description information used in discretionary grant program announcements to evaluate and rank applications. The UPD is an integral part of the application that employs a menu design allowing program offices to limit their request for information to only that which is relevant for a particular program. A menu approach minimizes hourly burden and Federal Register publication costs. 2015-10-31-04:00 Active Robert Sargis 2026907275 Yes Yes No 5519 331140 0

93.009 No Community and Social Services Social Services State, Local, and Tribal Governments 5 300 0

93.010 No Community and Social Services Social Services Private Sector 5 300 0

93.086 No Community and Social Services Social Services State, Local, and Tribal Governments 1178 70680 0

93.087 No Community and Social Services Social Services State, Local, and Tribal Governments 37 2220 0

93.254 No Community and Social Services Social Services State, Local, and Tribal Governments 9 540 0

93.550 No Community and Social Services Social Services State, Local, and Tribal Governments 200 12000 0

93.551 No Community and Social Services Social Services State, Local, and Tribal Governments 14 840 0

93.556 No Community and Social Services Social Services State, Local, and Tribal Governments 98 5880 0

93.557 No Community and Social Services Social Services State, Local, and Tribal Governments 229 13740 0

93.566 No Community and Social Services Social Services State, Local, and Tribal Governments 0 0 0

93.564 No Community and Social Services Social Services State, Local, and Tribal Governments 44 2640 0

93.567 No Community and Social Services Social Services State, Local, and Tribal Governments 9 540 0

93.569 No Community and Social Services Social Services State, Local, and Tribal Governments 0 0 0

93.570 No Community and Social Services Social Services State, Local, and Tribal Governments 191 11460 0

93.571 No Community and Social Services Social Services State, Local, and Tribal Governments 0 0 0

93.575 No Community and Social Services Social Services State, Local, and Tribal Governments 0 0 0

93.576 No Community and Social Services Social Services State, Local, and Tribal Governments 507 30420 0

93.577 No Community and Social Services Social Services State, Local, and Tribal Governments 0 0 0

93.579 No Community and Social Services Social Services State, Local, and Tribal Governments 5 300 0

93.581 No Community and Social Services Social Services State, Local, and Tribal Governments 34 2040 0

93.582 No Community and Social Services Social Services State, Local, and Tribal Governments 0 0 0

93.583 No Community and Social Services Social Services State, Local, and Tribal Governments 13 780 0

93.587 No Community and Social Services Social Services State, Local, and Tribal Governments 177 10620 0

93.592 No Community and Social Services Social Services State, Local, and Tribal Governments 28 1680 0

93.593 No Community and Social Services Social Services State, Local, and Tribal Governments 94 5640 0

93.595 No Community and Social Services Social Services State, Local, and Tribal Governments 5 300 0

93.597 No Community and Social Services Social Services State, Local, and Tribal Governments 5 300 0

93.598 No Community and Social Services Social Services State, Local, and Tribal Governments 58 3480 0

93.600 No Community and Social Services Social Services State, Local, and Tribal Governments 900 54000 0

93.601 No Community and Social Services Social Services State, Local, and Tribal Governments 25 1500 0

93.602 No Community and Social Services Social Services State, Local, and Tribal Governments 118 7080 0

93.604 No Community and Social Services Social Services State, Local, and Tribal Governments 28 1680 0

93.612 No Community and Social Services Social Services State, Local, and Tribal Governments 392 23520 0

93.616 No Community and Social Services Social Services State, Local, and Tribal Governments 5 300 0

93.618 No Community and Social Services Social Services State, Local, and Tribal Governments 0 0 0

93.623 No Community and Social Services Social Services State, Local, and Tribal Governments 239 14340 0

93.631 No Community and Social Services Social Services State, Local, and Tribal Governments 0 0 0

93.632 No Community and Social Services Social Services State, Local, and Tribal Governments 0 0 0

93.647 No Community and Social Services Social Services State, Local, and Tribal Governments 20 1200 0

93.648 No Community and Social Services Social Services State, Local, and Tribal Governments 5 300 0

93.652 No Community and Social Services Social Services State, Local, and Tribal Governments 171 10260 0

93.670 No Community and Social Services Social Services State, Local, and Tribal Governments 29 1740 0

93.671 No Community and Social Services Social Services State, Local, and Tribal Governments 0 0 0

93.676 No Community and Social Services Social Services State, Local, and Tribal Governments 40 2400 0

93.658 No Community and Social Services Social Services
1 Program Announcement No No Printable Only Form and instruction CATALOG_PROGRAM_TEXT_RPT.mht Yes Yes Fillable Printable Other CS-0079 PATS output 1-13-09_v1.doc
State, Local, and Tribal Governments 3 180 0

93.605 No Community and Social Services Social Services Private Sector 44 2640 0

93.708 No Community and Social Services Social Services Private Sector 5 300 0

93.709 No Community and Social Services Social Services Private Sector 9 540 0

93.711 No Community and Social Services Social Services Private Sector 5 300 0

93.590 No Community and Social Services Social Services Private Sector 0 0 0

93.710 No Community and Social Services Social Services State, Local, and Tribal Governments 0 0 0

93.093 No Community and Social Services Social Services
0124 and 0126 program announcement Yes Yes Printable Only Form and instruction ACF-OFA-0126 Health Profession - TANF and Low-Income.pdf 0124 and 0126 program announcement Yes Yes Printable Only Form and instruction ACF-OFA-0124_Health Profession_Tribal.pdf
State, Local, and Tribal Governments 35 2100 0

93.091 No Community and Social Services Social Services
0111 program announcement Yes Yes Printable Only Form and instruction HHS-2010-ACF-OCS-IB-0111.pdf
State, Local, and Tribal Governments 5 300 0

93.508 No Community and Social Services Social Services Private Sector 160 9600 0

93.060 No Community and Social Services Social Services Private Sector 60 3600 0

93.075 No Community and Social Services Social Services Private Sector 53 3180 0

93.076 No Community and Social Services Social Services Private Sector 53 3180 0

93.092 No Community and Social Services Social Services Individuals or Households 170 10200 0

2012-10-23-04:00

0970-0145 201108-0970-009 0970
             
        "Temporary Assistance for Needy Families (TANF) State Plan Guidance"
             
          
        
The State plan is a mandatory statement submitted to the Secretary of the Department of Health and Human Services by the State. It consists of an outline of how the State's TANF program will be administered and operated and certain required certifications by the State's Chief Executive Officer. Its submittal triggers the State's family assistance grant. 2014-09-30-04:00 Active Robert Sargis 2026907275 No No No 36 594 0

Temporary Assistance for Needy Families (TANF) State Plan Guidance-State Plan No Community and Social Services Social Services State, Local, and Tribal Governments 18 540 0

State Plan Title Amendments No Community and Social Services Social Services State, Local, and Tribal Governments 18 54 0

2011-09-23-04:00

0970-0148 201302-0970-001 0970
             
        "42 C.F.R. 1304 Head Start Program Performance Standards"
             
          
        
45 CFR Section 1304 contains the standards for services provided to children and their families who are enrolled in the Head Start program. 2016-08-31-04:00 Active Robert Sargis 2026907275 No No No 41440 1737618 0

42 C.F.R. 1304 Head Start Program Performance Standards No Community and Social Services Social Services Private Sector 41440 1737618 0

2013-08-19-04:00

0970-0150 201205-0970-007 0970
             
        "Child Care and Development Fund Annual Aggregate Report"
             
          
        
The Child Care and Development Block Grant (CCDBG) Act of 1990, as amended, requires that States and Territories submit annual aggregated data on the children and families receiving direct services. On an annual basis, States and Territories provide agregated data which is used in reports to Congress, addressing national child care needs, research, technical assistance, and meeting performance measure requirements. 2015-06-30-04:00 Active Robert Sargis 2026907275 No No No 56 2240 280000

Child Care and Development Fund Annual Aggregate Report No Community and Social Services Social Services
ACF-800 Aggregate Report Yes Yes Paper Only Form ACF-800 Form (Final).doc Yes Yes Paper Only Instruction ACF-800 Instructions (Final).doc
State, Local, and Tribal Governments 56 2240 280000

2012-06-25-04:00

0970-0152 201309-0970-001 0970
             
        "Administrative Subpoena"
             
          
        
Section 452(a)(11) of the Social Security Act requires the Secretary of HHS to promulgate a form for administrative subpoenas to be used by State child support enforcement programs to collect information for use in the establishment, modification and enforcement of child support orders in interstate cases. Section 454(9)(E) of the Act requires each State to cooperate with any other State in using the Federal form for issuance of administrative subpoenas in interstate child support cases. Tribes are not required to use this form, but may chose to do so. 2016-12-31-05:00 Active Robert Sargis 2026907275 No No No 53488 26744 0

Administrative Subpoena No Community and Social Services Social Services
1 Subpoena Yes Yes Fillable Printable Form and instruction PRA Interstate Administrative Subpoena Form 08012013 Submitted.doc
State, Local, and Tribal Governments 53488 26744 0

2013-12-04-05:00

0970-0153 201309-0970-002 0970
             
        "Notice of Lien"
             
          
        
P. L. 104-193, the Personal Responsibility and Work Opportunity Act of 1996 amended section 452(a)(11) of the Social Security Act (the Act) to require the Federal Office of Child Support Enforcement (OCSE) to promulgate a form to be used by State child support enforcement (IV-D) agencies in interstate cases. The Notice of Lien is used by State CSE programs to encumber property located in other States by filing the Lien directly in the other State. The requirement that the State CSE program secure child support debts by filing liens is a long-standing requirement of the CSE program. 2016-12-31-05:00 Active Robert Sargis 2026907275 No No No 1876922 469231 0

Notice of Lien No Community and Social Services Social Services
1 Notice of Lien Yes Yes Fillable Printable Form and instruction PRA Notice of Lien Form 08012013 Submitted.doc
State, Local, and Tribal Governments 1876922 469231 0

2013-12-04-05:00

0970-0154 201102-0970-002 0970
             
        "Order to Withhold Income for Child Support and Notice of an Order to Withhold Income for Child Support"
             
          
        
The Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) of 1996, Section 324, requires the Federal Office of Child Support Enforcement (OCSE) to develop a standardized form to collect child support payments from an obligor's employer. The form, which promotes standardization, expires 5/31/2007, and ACF is taking this opportunity to revise the form and its instructions. 2014-05-31-04:00 Active Robert Sargis 2026907275 No No No 11830020 492786 21021695

IWO No Community and Social Services Social Services
No No Paper Only Other 03 Draft IWO 04-25-07.doc No No Paper Only Other 03 Draft IWO INSTRUCTIONS 04_25_07.doc 1 Revised form Yes Yes Paper Only Form Income Withholding Form Revised10192007v2.doc
State, Local, and Tribal Governments 0 0 0

Manual No Community and Social Services Social Services State, Local, and Tribal Governments 0 0 0

e-IWO No Community and Social Services Social Services State, Local, and Tribal Governments 0 0 0

Employers No Community and Social Services Social Services
Yes Yes Fillable Fileable Instruction Attachment B - Income Withholding for Support Instructions.doc 1 Record Layout Yes Yes Fillable Fileable Form and instruction Attachment E--e-IWO Record Layout.doc 1 Withholding for Support Yes Yes Fillable Fileable Form Attachment A - Income Withholding for Support, OMB 0970-0154.doc
Private Sector 9860976 328699 15272087

Non-IV-D-CPs No Community and Social Services Social Services
Yes No Fillable Printable Instruction Attachment B - Income Withholding for Support Instructions.doc Attachment A Attachment A - Income Withholding for Support, OMB Yes No Fillable Printable Form Attachment A - Income Withholding for Support, OMB 0970-0154.doc
State, Local, and Tribal Governments 1969044 164087 5749608

2011-05-06-04:00

0970-0155 201107-0970-008 0970
             
        "Community-Based Family Resource and Support Grants"
             
          
        
The information being collected is required by statute to be submitted pursuant to receiving an award. The information submitted will be used by ACYF to ensure compliance with the stature, complete the calculation of the grant award entitlement, and provide training and technical assistance to the grantee. The information is provided by a representative of the lead agency, designated by the State's Chief Executive Officer to receive the funds and implement the program for the State. Annual Perfomance reports (Section 207 of Title II) and Financial Reports, using SF269 (USC Code 92 are required. These reports provide updates and changes in goals and services and indicate how the funds are being used. 2014-10-31-04:00 Active Robert Sargis 2026907275 No No No 104 3328 0

Community-Based Child Abuse Prevent Program-Annual Report No Community and Social Services Social Services State, Local, and Tribal Governments 52 1248 0

Commuunity-Based Child Abuse Prevention Program-Application No Community and Social Services Social Services State, Local, and Tribal Governments 52 2080 0

2011-10-23-04:00

0970-0157 201309-0970-004 0970
             
        "Guidance for the Tribal Temporary Assistance for Needy Families (TANF) Program"
             
          
        
42 U.S.C. 612 (section 412 of the Social Security Act) requires each Indian tribe than elects to administer and operate a TANF program to submit a TANF Tribal plan. The Tribal plan is a mandatory statement submitted to the Secretary by the Indian tribe, which consists of an outline of how the Indian tribe's TANF program will be administered and operated. It is used by the Secretary to determine the plan is approvable and to determine that the Indian tribe is eligible to receive a TANF assistance grant. It is also made available to the public. 2016-10-31-04:00 Active Robert Sargis 2026907275 No No No 23 1564 0

Guidance for the Tribal Temporary Assistance for Needy Families (TANF) Program No Community and Social Services Social Services
1 Guidance for Tribal TANF Yes Yes Fillable Printable Form and instruction TribalTANFGuide5-29-13.docx
State, Local, and Tribal Governments 23 1564 0

2013-10-30-04:00

0970-0160 201301-0970-014 0970
             
        "Procedures for Requests from Tribal Child Care Lead Agencies to Use Child Care and Development Fund (CCDF) for Construction or Major Renovation of Child Care Facilities"
             
          
        
The Child Care and Development Block Grant Act, as amended, allows Indian Tribes to use Child Care and Development Fund (CCDF) grant awards for construction and renovation of child care facilities. A tribal grantee must first request and receive approval from the Administration for Children and Families (ACF) before using CCDF funds for construction or major renovation. This information collection contains the statutorily-mandated uniform procedures for the solicitation and consideration of requests. 2016-03-31-04:00 Active Robert Sargis 2026907275 No No No 5 100 0

PI for Tribal CCDF for Construction or Major Renovation of Child Care Facilities No Community and Social Services Social Services State, Local, and Tribal Governments 5 100 0

2013-03-19-04:00

0970-0161 201307-0970-008 0970
             
        "Federal Tax Offset, Administrative Offset, and Passport Denial Programs"
             
          
        
On an ongoing basis, Child Support Enforcement (CSE) agencies submit to the Federal Office of Child Support Enforcement (OCSE) the names, Social Security numbers (SSNs) and the amount(s) of past-due child support of people who are delinquent in making child support payments. The Tax Refund Offset and Administrative Offset Programs collect past-due child support by intercepting certain federal payments, including federal tax refunds, of parents who have been ordered to pay child support and are behind in paying the debt. 2016-05-31-04:00 Active Robert Sargis 2026907275 No No No 57680 2929 0

Payment File No Health Illness Prevention State, Local, and Tribal Governments 2808 379 0

Annual Certification Letter No Health Illness Prevention State, Local, and Tribal Governments 54 22 0

Input Record No Health Illness Prevention State, Local, and Tribal Governments 2808 842 0

Output Record No Health Illness Prevention State, Local, and Tribal Governments 2808 1292 0

Federal Offset Processing Menu Screens - State Workers No Health Illness Prevention State, Local, and Tribal Governments 49202 394 0

2013-08-19-04:00

0970-0163 201302-0970-003 0970
             
        "Child Care and Development Fund Quarterly Financial Report"
             
          
        
States use this form to facilitate the reporting of expenditures for the Child Care and Development Fund. State agencies will use this form to report claim on a quarterly basis. The form provides specific data regarding financial disbursements, obligations, and estimates. It provides States with a mechanism to request grant awards and certify the availability of State matching funds. Failure to collect this data would seriously compromise the Administration for Children and Families ability to monitor expenditures. This form may also be used to prepare ACF burden submissions to Congress. 2016-05-31-04:00 Active Robert Sargis 2026907275 No No No 224 896 0

Child Care and Development Fund Quarterly Financial Report No Community and Social Services Social Services
ACF-696 CCDF Financial Report Yes Yes Fillable Fileable Form and instruction FINAL Draft ACF-696 Form and Instructions 2jan13.docx
State, Local, and Tribal Governments 224 896 0

2013-05-02-04:00

0970-0166 201305-0970-005 0970
             
        "National Directory of New Hires"
             
          
        
Public Law 104-193, the "Personal Responsibility and Work Opportunity Reconciliation Act of 1996," requires the Office of Child Support Enforcement (OCSE) to operate a National Directory of New Hires (NDNH) to improve the ability of state child support enforcement agencies to locate noncustodial parents and collect child support across state lines. The law requires employers to report newly hired employees to states. States are then required to periodically transmit new hire data received from employers to the NDNH. 2016-05-31-04:00 Active Robert Sargis 2026907275 No No No 69489619 450476 0

New Hire: Employer Reporting Manually No Community and Social Services Social Services
1 Lay Out No No Fillable Printable Form and instruction W4 record layouts_vfinal 2013.doc
State, Local, and Tribal Governments 10484041 262101 0

QW and UI No Community and Social Services Social Services
1 lay out No No Fillable Fileable Form and instruction QW record layouts_vfinal 2013.doc 1 lay out Yes Yes Fillable Fileable Form and instruction UI record layouts_vfinal 2013.doc
State, Local, and Tribal Governments 1431 0 0

New Hire States No Community and Social Services Social Services
1 lay out Yes Yes Fillable Fileable Form and instruction W4 record layouts_vfinal 2013.doc
State, Local, and Tribal Governments 10473138 174556 0

New Hire Employer - Electronic No Community and Social Services Social Services
1 lay out Yes Yes Fillable Fileable Form and instruction W4 record layouts_vfinal 2013.doc
State, Local, and Tribal Governments 48526377 13587 0

Multistate Employer Notification Form No Community and Social Services Social Services
1 form Yes Yes Fillable Fileable Form and instruction MSE FORM final 2013.doc
State, Local, and Tribal Governments 4632 232 0

2013-05-28-04:00

0970-0167 201112-0970-003 0970
             
        "Child Care Quartely Case-Level Report - ACF-801"
             
          
        
The Child Care and Development Block Grant Act of 1990, as amended, requires that States and Territories submit monthly case-level data on the children and families receiving direct services. On a quarterly or monthly basis (at grantee option). States and Territories provide monthly sample or full population case-level data which is used in reports to Congress, addressing national child care needs, research, technical assistance, and meeting performance measure requirements. 2015-04-30-04:00 Active Robert Sargis 2026907275 No No No 224 5600 380800

Child Care Case-Level Report No Community and Social Services Social Services
ACF-801 Quarterly Case Record Report Yes Yes Fillable Printable Form and instruction ACF-801 Form and Instructions Proposed Revisions (Final Version 2 0) 12-2.doc
State, Local, and Tribal Governments 224 5600 380800

2012-04-09-04:00

0970-0171 201104-0970-003 0970
             
        "Required Data Elements for Paternity Establishment Affidavits"
             
          
        
Sections of the Social Security Act require the Secretary of Health and Human Services to specify the minimum requirements of an affidavit to be used for the voluntary establishment of paternity. The Act also requires States to enact laws requiring the development and the use of an affidavit for the voluntary acknowledgement of paternity which includes the minimum requirements of the affidavit specified by the Secretary. The information collected will be used by State birth record agencies and State IV-D offices, if needed, in child support enforcement activities. 2014-06-30-04:00 Active Robert Sargis 2026907275 No No No 1167097 198406 0

Required Data Elements for Paternity Establishment Affidavits No Community and Social Services Social Services Individuals or Households 1167097 198406 0

2011-06-13-04:00

0970-0174 201211-0970-001 0970
             
        "Native Employment Works (NEW) Program Plan Guidance and Program Report"
             
          
        
The NEW program plan guidance specifies the information needed to complete a NEW program plan and explains the process for plan submission every third year. The program plan is the application for NEW program funding. As approved by HHS, the plan documents how the grantee will carry out its NEW program. The NEW program report and instructions specify the program data that NEW grantees report annually. The program report provides HHS, Congress, and grantees information to document the activities and accomplishments of the NEW program and to assess the success of the NEW program in meeting its goals. HHS needs the information in the program plan and the program report to fulfill statutory and regulatory requirements. The respondents are federally-recognized Indian tribes and tribal organizations that are NEW program grantees. 2016-02-29-05:00 Active Robert Sargis 2026907275 No No No 74 1484 0

NEW Plan Guidance for non-477 Tribes No Community and Social Services Social Services State, Local, and Tribal Governments 16 464 0

New Program Report No Community and Social Services Social Services
1 New Report 2013 Revisions Yes Yes Fillable Printable Form and instruction NEW program report 2013 revisions.docx
State, Local, and Tribal Governments 48 720 0

NEW Program Guidance for 477 Tribes No Community and Social Services Social Services State, Local, and Tribal Governments 10 300 0

2013-02-14-05:00

0970-0175 201104-0970-002 0970
             
        "Voluntary Establishment of Paternity"
             
          
        
Section 466(a)(5)(C) of the Social Security Act requires States to pass laws ensuring a simple civil process for voluntarily acknowledging paternity under which the State must provide that the mother and putative father must be given notice, orally and in writing, of the benefits and legal responsibilities and consequences of acknowledging paternity. The information is to be used by hospitals, birth record agencies, and other entities participating in the voluntary paternity establishment program. 2014-07-31-04:00 Active Robert Sargis 2026907275 No No No 2494152 424006 2893216

Voluntary Establishment of Paternity No Community and Social Services Social Services State, Local, and Tribal Governments 2494152 424006 2893216

2011-07-20-04:00

0970-0177 201108-0970-004 0970
             
        "OCSE-157 Child Support Enforcement Annual Data Report"
             
          
        
The information obtained from this form will be used to report Child Support Enforcement activities to the Congress as required by law, to complete performance indicators and incentives utilized in the program, and to assist the Office of Child Support Enforcement in monitoring and evaluating State Child Support Enforcement programs. 2014-09-30-04:00 Active Robert Sargis 2026907275 No No No 54 378 0

OCSE-157 Child Support Enforcement Annual Data Report No Community and Social Services Social Services
OCSE-157 Annual Data Report Yes Yes Fillable Printable Form and instruction FINAL 8-16-11 OCSE 157 Form and instructions-OMB Renewal Pkg.docx
State, Local, and Tribal Governments 54 378 0

2011-09-27-04:00

0970-0181 201011-0970-005 0970
             
        "Child Support Enforcement Program Financial Report Child Support Enforcement Program Quarterly Report of Collection"
             
          
        
These forms are used for the Child Support Enforcement Program under title IV-D of the Social Security Act. With these forms, States report assorted administrative expenditures made each quarter and the amounts collected as child support payments each quarter. This reporting also includes a breakdown of the collected payments that are distributed to the custodial parent or to the Federal or State governments. These forms also allow States to report the estimated amount of the performance-based incentive payment earned each quarter and an itemized rationale for the States balances of undistributed collections. The expenditure and collection information is used to calculate quarterly grant awards and annual incentive payments to the States, and is published in an Annual Report available to the general public. Respondents are limited to the designated child support enforcement agencies in each State. 2014-02-28-05:00 Active Robert Sargis 2026907275 No No No 432 4320 0

Form OCSE-34A, "Quarterly Report of Collections" No Community and Social Services Social Services
OCSE-34A Quarterly Financial Report Yes Yes Fillable Fileable Signable Form Form OCSE34A - DRAFT 2007.pdf
State, Local, and Tribal Governments 216 3024 0

Form OCSE-396A, "Quarterly Report of Expenditures" No Community and Social Services Social Services
OCSE-396A Quaterly Report of Expenditures No No Fillable Fileable Signable Form Form OCSE396A DRAFT 2007.pdf
State, Local, and Tribal Governments 216 1296 0

2011-02-07-05:00

0970-0186 201111-0970-003 0970
             
        "Methodology for Determining Whether an Increase in a State's Child Poverty Rate is the Result of the TANF Program"
             
          
        
Per Section 413(i)(5) of the Social Security Act and 45 CFR Part 284, HHS intends to reinstate the following information collection requirements. If Census data show that a State's child poverty rate increased 5% or more from 1 year to the next, the State will be required to submit. 2014-12-31-05:00 Active Robert Sargis 2026907275 No No No 156 14976 0

Optional Submission No Community and Social Services Social Services State, Local, and Tribal Governments 52 416 0

Corrective Action No Community and Social Services Social Services State, Local, and Tribal Governments 52 8320 0

Assessment of Impact No Community and Social Services Social Services State, Local, and Tribal Governments 52 6240 0

2011-12-15-05:00

0970-0193 201206-0970-004 0970
             
        "45 CFR 1309 Purchase, Construction and Major Renovation of Head Start Facilities"
             
          
        
This rule ensures that standard business practices are applied when acquired with government funds. 2015-08-31-04:00 Active Robert Sargis 2026907275 No No No 4100 8200 0

45 CFR 1309 Purchase, Construction and Major Renovation of Head Start Facilities No Community and Social Services Social Services Private Sector 4100 8200 0

2012-08-07-04:00

0970-0195 201302-0970-002 0970
             
        "Child Care and Development Fund Annual Financial Report for Tribes (CCDF)"
             
          
        
The (CCDF) annual financial reporting form (ACF-696T) provides a mechanism for Indian Tribes to report expenditures under the CCDF program. The CCDF program provides funds to Tribes, as well as States and Territories, to assist low-income families in obtaining child care so they can work or attend training/education and to imrpove the quality of care. Data collected via the ACF-696T allows the ACF to monitor tribal expenditures. This information collection uses the existing ACF-696T form but proposes some clarifications to the form's instructions. Respondents are CCDF tribal grantees. 2016-05-31-04:00 Active Robert Sargis 2026907275 No No No 260 1560 0

Child Care and Development Fund Annual Financial Report for Tribes (CCDF) No Community and Social Services Social Services
ACF-196T Tribal Financial Report Yes Yes Fillable Printable Form Financial Report Form 696T 24Jan13 FINAL-Form.xlsx
State, Local, and Tribal Governments 260 1560 0

2013-05-02-04:00

0970-0196 201108-0970-005 0970
             
        "Financial Institution Data Match"
             
          
        
Section 466(a)(17) of the Social Security Act (the Act), requires states to establish procedures under which the state child support enforcement (IV-D) agency shall enter into agreements with financial institutions doing business in the state for the purpose of securing information leading to the enforcement of child support orders. Under 452(1) of the Act, financial institutions doing business in multiple states may comply by centrally matching through the Federal Parent Locator Service rather than matching in each state in which the financial institution conducts business. 2014-05-31-04:00 Active Robert Sargis 2026907275 No No No 1362 403 424519

Election Form No Community and Social Services Social Services
1 Election Form Yes Yes Fillable Fileable Form and instruction MSFIDM Election Form 2010 PRA_08.03.10.doc
Private Sector 122 61 2562

Financial Data Match Tape No Community and Social Services Social Services
1 Data Match Results Specification Yes Yes Fillable Printable Form and instruction 01 MSFIDM Data Match Specifications 08 03 10.doc
Private Sector 1036 342 356840

Electronic Transmission Financial Data Match Result File No Community and Social Services Community and Regional Development State, Local, and Tribal Governments 204 0 65117

2011-09-14-04:00

0970-0198 201303-0970-002 0970
             
        "Child Care and Development Fund Tribal Plan "
             
          
        
The Child Care and Development Fund (CCDF) Tribal Plan serves as the agreement between the applicant (Tribe, tribal consortium or tribal organization) and the Federal government that describes how tribal applicants will operate CCDF Block Grant programs in conformance with legislative requirements, federal regulations and other applicable instructions or guidelines issued by the Administration for Children and Families. 2016-05-31-04:00 Active Robert Sargis 2026907275 No No No 129 15420 0

Child Care and Development fund Tribal Plan Preprint (ACF-118-A) No Community and Social Services Social Services
ACF-118-A CCDF Tribal Plan Preprint Yes Yes Fillable Printable Form and instruction FR2 FY 2014-2015 CCDF Tribal Plan 2-20-13.pdf
State, Local, and Tribal Governments 129 15420 0

2013-05-02-04:00

0970-0202 201105-0970-005 0970
             
        "National Survey of Child and Adolescent Well-Being Second Cohort (NSCAW II)"
             
          
        
NSCAW II will collect information on a second cohort of a nationally representative, longitudinal survey of children and families who are investigated for a report of child maltreatment. Information is to be collected directly from children, their caregivers, caseworkers and teachers to focus on children's functioning, well-being, and service utilization. 2014-08-31-04:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 12048 13789 0

Child Interview No Community and Social Services Social Services Individuals or Households 2937 3436 0

Caregiver Interview No Community and Social Services Social Services Individuals or Households 2937 4698 0

Caseworker Interview No Community and Social Services Social Services Individuals or Households 5138 5137 0

Teacher Questionaire No Community and Social Services Social Services Individuals or Households 1036 518 0

2011-08-18-04:00

0970-0204 201204-0970-004 0970
             
        "Grants to States for Access and Visitation"
             
          
        
The PRWORA of 1996 provides funding for state programs to facilitate noncustodial parents' access to and visitation of their children. Formula grants are provided to each state and territory. States are required to provide OCSE - on an annual basis - with information on services funded along with the inclusion of relevant data such as the number of persons served, sources of referrals, and program outcomes. 2015-07-31-04:00 Active Robert Sargis 2026907275 No No No 354 5664 0

Grants to States for Access and Visitation No Community and Social Services Social Services
1 2013-2015 State Spreadsheet Yes Yes Fillable Printable Form FY 2013-2015 State Spread Sheet FINAL April 11 2012.xls
State, Local, and Tribal Governments 54 864 0

Grants to States for Access and Visitation (Local Service Providers) No Community and Social Services Social Services
1 Local Spread Sheet Yes Yes Fillable Printable Form FY 2013-2015 Local Spread Sheet FINAL April 11 2012.xls
State, Local, and Tribal Governments 300 4800 0

2012-07-17-04:00

0970-0205 201306-0970-003 0970
             
        "IV-E Foster Care and Adoption Assistance Quarterly Financial Report"
             
          
        
This form is used by States (including DC and PR)and Tribes to report the Total and Federal share of program expenditures made during the preceding quarter and to report the estimated Total and Federal share of the same expenditures to be made in the upcoming quarter for the Foster Care, Adoption Assistance and Guardianship Assistance programs under Title IV-E of the Social Security Act. This information is used to calculate quarterly grant awards and the collected data is available to the general public. Respondents are limited to the designated Title IV-E agency in each State or Tribe. 2016-08-31-04:00 Active Robert Sargis 2026907275 No No No 248 4960 0

Form CB-496, "Title IV-E Program Quarterly Financial Report No Community and Social Services Social Services
Yes Yes Fillable Printable Instruction Form CB-496 Instructions - DRAFT May 2013.doc CB-496 Quarterly Financial Report Yes Yes Fillable Printable Form Form CB-496 - DRAFT May 2013 - Part 3.pdf CB-496 Title IV-E Programs Quarterly Financial Report No No Fillable Printable Form Form CB-496 - DRAFT May 2013 - Parts 1 and 2.pdf
State, Local, and Tribal Governments 248 4960 0

2013-08-27-04:00

0970-0207 201301-0970-003 0970
             
        "Head Start Grant Application and Budget Instrument"
             
          
        
Head Start Grant Application standardizes the information collected from applicants and streamlines the application process by allowing for electronic submission of applications for funding. 2016-03-31-04:00 Active Robert Sargis 2026907275 No No No 1600 52800 0

Head Start Grant Application and Budget Instrument No Community and Social Services Social Services
1 GABI Yes Yes Fillable Printable Form and instruction GABI Instrument and Instructions 2013.pdf
Private Sector 1600 52800 0

2013-03-08-05:00

0970-0209 201202-0970-001 0970
             
        "Online Interstate Referral Guide (IRG)"
             
          
        
The IRG is an essential reference maintained by OCSE that provides State IV-D agencies with the information needed to process interstate cases. The Online version of the IRG provides states with an effective and efficient way of viewing and updating state profile, address, and FIPS code information by consolidating data available through numerous discrete sources into a single centralized, automated repository. 2015-03-31-04:00 Active Robert Sargis 2026907275 No No No 1960 578 0

IRG Tribal User Guide No Community and Social Services Social Services State, Local, and Tribal Governments 936 281 0

IRG State User Guide-Foreign Nations No Community and Social Services Social Services State, Local, and Tribal Governments 52 5 0

IRG State User Guide - States and Territories No Community and Social Services Social Services State, Local, and Tribal Governments 972 292 0

2012-03-27-04:00

0970-0214 201202-0970-002 0970
             
        "Title IV-E Foster Care Eligibility Reviews, Child and Family Services Reviews"
             
          
        
The information collected is needed: 1) to conduct federal onsite eligibility reviews of Title IV-E of the Social Security Act (the Act), "Federal Payments for Foster Care and Adoption Assistance"; and 2) to monitor state plan requirements under Title IV-B and IV-E of the Act, as required by Federal statute. The resultant information will determine if states are in compliance with state plan requirements and are achieving desired outcomes for children and families, as well as assure eligibility for federall-assisted foster care expenditures. These reviews will not only address compliance with eligibility requirements, but also assist States in enhancing their capacities to serve children and families. The Act also deploys anti-discrimination enforcement provisions which include the execution and completion of corrective action plans when a State is in violation of the Act. 2015-01-31-05:00 Active Robert Sargis 2026907275 No No No 51 24600 492000

Title IV-E Foster Care Eligibility Review Program Improvement Plan No Community and Social Services Social Services State, Local, and Tribal Governments 8 720 14400

Child and Family Services Review Statewide Assessment No Community and Social Services Social Services
1 Statewide Assessment Yes Yes Fillable Printable Form and instruction Statewide_Assessment1 08-26-2009.doc
State, Local, and Tribal Governments 14 3360 67200

Child and Family Services Review On-Site Review No Community and Social Services Homeownership Promotion
1 Onsite Review Instrument Yes Yes Fillable Printable Form and instruction Onsite Review Instrument (Final July 2008) 08-26-2009.doc
State, Local, and Tribal Governments 14 16380 327600

Child and Family Services Review Program Improvement Plan No Community and Social Services Social Services
1 PIP Matrix Yes Yes Fillable Printable Form and instruction PIP Matrix Instruct 10 07 08-26-2009.doc
State, Local, and Tribal Governments 14 3360 67200

Anti-Discrimination Enforcement Corrective Action Plans No Community and Social Services Social Services State, Local, and Tribal Governments 1 780 15600

2012-02-07-05:00

0970-0215 201207-0970-006 0970
             
        "Final Tribal TANF Data Report"
             
          
        
42 U.S.C. 612 (Section 412 of the Social Security Act as amended by Pub. L. 104-193, the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA)and the Deficit Reduction Act of 2005 (DRA)) mandates that Federally recognized Indian Tribes with an approved Tribal TANF program collect and submit to the Secretary of the Department of Health and Human Services data on the recipients served by the Tribes' programs. This information includes both aggregated and disaggregated data on case characteristics and individual characteristics. In addition, Tribes that are subject to a penalty are allowed to provide reasonable cause justifications as to why a penalty should not be imposed or may develop and implement corrective compliance procedures to eliminate the source of the penalty. Finally, there is an annual report, which requires the Tribes to describe program characteristics. All of the above requirements are currently approved by OMB and the Administration for Children and Families is simply proposing to extend them without any changes. 2015-09-30-04:00 Active Robert Sargis 2026907275 No No No 396 125664 0

Final Tribal TANF Data Report No Community and Social Services Social Services State, Local, and Tribal Governments 264 119064 0

Tribal TANF Annual Report No Community and Social Services Social Services State, Local, and Tribal Governments 66 2640 0

Tribal TANF Reasonable Cause No Community and Social Services Social Services State, Local, and Tribal Governments 66 3960 0

2012-09-06-04:00

0970-0218 201309-0970-006 0970
             
        "Tribal Child Support Direct Funding Regulation - Final"
             
          
        
The final rule within 45 CFR part 309, published in the Federal Register on March 30, 2004, contains a regulatory reporting requirement that in order to receive funding for a Tribal IV-D program a Tribe or Tribal organization must submit a plan describing how the Tribe or Tribal organization meets or plans to meet the objectives of section 455(f) of the Social Security Act, including establishing paternity, establishing, modifying, and enforcing support orders, and locating noncustodial parents. The plan is required for all Tribes requesting funding; however, once a Tribe has met the requirements to operate a comprehensive program, a new plan is not required annually unless a Tribe makes changes to its title IV-D program. Tribes and Tribal organizations must respond if they wish to operate a fully funded program. In addition, any Tribe or Tribal organization participating in the program will be required to submit form OCSE 34A. This paperwork collection activity was extended through August 31, 2010. 2016-12-31-05:00 Active Robert Sargis 2026907275 No No No 120 57600 0

45 CFR 309 Plan No Community and Social Services Social Services State, Local, and Tribal Governments 120 57600 0

OCSE Form 34-A No Community and Social Services Social Services
OCSE 34A OCSE 34A No No Paper Only Form 34A.pdf
State, Local, and Tribal Governments 0 0 0

2013-12-04-05:00

0970-0222 201308-0970-003 0970
             
        "National Medical Support Notice"
             
          
        
Section 401 of the Child Support Performance and Incentives Act of 1998 (CSPIA) Pub.L. 105-200 requires State Child Support Enforcement agencies under title IV-D of the Social Security Act (the Act) to enforce the health care coverage provision in a child support order, and to use the National Medical Support Notice (NMSN) as a means of enforcement. The law requires the NMSN to be promulgated by regulations issued jointly by the Departments of Health and Human Service (HHS) and Labor (DOL). The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) requires all child support orders under title IV-D of the Act to have a provision for medical support coverage. CSPIA requires enforcement of this provision and to use the NMSN as a means of enforcement. State and local Child Support Enforcement agencies send the NMSN to known employers where employees/obligors are employed for the purpose of enrollment of the child into the employee/obligor's health plan. The employer retains the severable wage-withholding portion of the form and withholds from the employee/obligor's wages any premium payments that may be required by the plan. The employer sends the remaining portion of the NMSN to the health plan administrator for enrollment of the child. 2016-08-31-04:00 Active Robert Sargis 2026907275 No No No 5279850 897575 0

National Medical Support Notice No Community and Social Services Social Services
1 NMSN Part A No No Fillable Fileable Form and instruction NMSN Part A OMB 0970-0222 FINAL.doc
State, Local, and Tribal Governments 5279850 897575 0

2013-09-30-04:00

0970-0223 201303-0970-008 0970
             
        "State Self-Assessment Review and Report"
             
          
        
The Federal Office of Child Support Enforcement (OCSE) oversees administration of the Child Support Enforcement program in the 54 States and jurisdictions that participate in it. The Federal government sets program standards and policy, evaluates States' performance in conducting their program, and offers technical assistance and training to the States. It also conducts audits of State program activities. In its oversight role, the Federal government is responsible for receiving Self-Assessment reports submitted by states and, as appropriate, providing to the States comments, recommendations for additional or corrective action, and technical assistance that a State may need. In addition, the submitted reports are reviewed and analyzed by the Office of Child Support Enforcement(OCSE)to identify "best practices" to be shared with other States. The authority to collect and report information requested on this form is found in section 454(15)(A) of the Social Security Act(see Attachment A). The Self-Assessment reports are intended to give States the opportunity to assess whether they are meeting Federal requirements for providing child support services and providing the best services possible. In addition, these reports are used by OCSE to monitor State compliance in areas critical to successful State child support programs. Child support enforcement can play a pivotal role in reducing welfare dependency, with savings to the Federal Government. One aspect of motivating States to take the necessary action is to pinpoint program areas where improvement is critical and warrants priority attention. 2016-05-31-04:00 Active Robert Sargis 2026907275 No No No 54 216 0

State Self-Assessment Review and Report No Community and Social Services Social Services
1 CSE Program Self-Assessment Report Yes Yes Fillable Printable Form and instruction SAR Reporting Format and Instructions 2-2010.doc
State, Local, and Tribal Governments 54 216 0

2013-05-10-04:00

0970-0229 201202-0970-004 0970
             
        "Head Start Impact Study (HSIS)  -- tracking survey"
             
          
        
This information collection request will enable ACF to collect updated information on the respondents in the Head Start Impact Study so the agency may track respondents in preparation for a follow up during or soon after the high school years. 2015-04-30-04:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 4235 1412 0

Tracking of Participants in the Head Start Impact Study No Community and Social Services Social Services Individuals or Households 4235 1412 0

2012-04-20-04:00

0970-0230 201111-0970-001 0970
             
        "State High Performance Bonus system (HPBS) Transmission File Layouts for HPBS work measures"
             
          
        
The purpose of this collection is to obtain data upon which to base the computation for measuring State performance in meeting the goals of TANF and awarding bonus grant funds appropriated under the law. States will not be required to submit this information unless they elect to compete for the bonus grants. Respondents may include any of the 50 States, the District of Columbia, and the U.S. Territories of Guam, Puerto Rico, and the Virgin Islands. 2014-12-31-05:00 Active Robert Sargis 2026907275 No No No 84 1008 0

Transmission Layouts on TANF HPB No Community and Social Services Social Services State, Local, and Tribal Governments 84 1008 0

2011-12-28-05:00

0970-0234 201103-0970-003 0970
             
        "Social Services Block Grant Postexpenditure Report"
             
          
        
According to the annual reporting requirements for SSBG, in the Fed. Reg., Vol. 58, No. 218, on November 15, 1993, States are required to report their annual SSBG expenditures on a standard post-expenditure report. Approval is being sought for an extension for continued use of the post-expenditure report form with no changes. Data collected are analyzed and published in an annual report on SSBG expenditures and recipients produced by the Office of Community Services. 2014-06-30-04:00 Active Robert Sargis 2026907275 No No No 112 6272 0

Social Services Block Grant Preexpenditure Report No Community and Social Services Social Services
1 Intended Use Estimates Yes Yes Fillable Fileable Form and instruction Attachment C_SSBG Reporting Form_Intended Use Plan.doc
State, Local, and Tribal Governments 56 112 0

Social Services Block Grant Postexpenditure Report No Community and Social Services Social Services
1 SSBG Reporting Form Yes Yes Fillable Fileable Form Attachment A_SSBG Reporting Form_Postexpenditure.doc
State, Local, and Tribal Governments 56 6160 0

2011-06-27-04:00

0970-0247 201307-0970-004 0970
             
        "Temporary Assistance for Needy Families Quarterly Financial Report"
             
          
        
The form is used by states to report expenditures under the temporary assistance for needy families program. State agencies will use this form to report data on a quarterly basis. The form provides data on financial disbursements, obligations, and estimates, it provides states with a mechanism to request program funding and certify the availability of state matching funds. Failure to collect this data would seriously compromise the administration for children and families' ability to monitor expenditures. This form may also be used to prepare congressional budget. 2016-08-31-04:00 Active Robert Sargis 2026907275 Yes No No 204 2040 0

Temporary Assistance for Needy Families Quarterly Financial Report No Community and Social Services Social Services
ACF-196 TANF Financial Report Yes Yes Fillable Fileable Form ACF 196 Final with ARRA 8Mar13.xls
State, Local, and Tribal Governments 204 2040 0

2013-08-19-04:00

0970-0248 201111-0970-002 0970
             
        "Instructions for Annual Report on State Maintenance-of-Effort Programs:  Form ACF-204"
             
          
        
The report is used to collect descriptive program characteristics information on the programs operated by States and Territories in association with their Temporary Assistance for Needy Families (TANF) programs. All State and Territory expenditures claimed toward States and Territories MOE requirements must be appropriate, i.e., meet all applicable MOE requirements. The Annual MOE Report provides the ability to learn about and to monitor the nature of State and Territory expenditures used to meet States and Territories MOE requirements, and it is an important source of information about the different ways that States and Territories are using their resources to help families attain and maintain self-sufficiency. In addition, the report is used to obtain State and Territory program characteristics for ACFs annual report to Congress, and the report serves as a useful resource to use in Congressional hearings about how TANF programs are evolving, in assessing State and Territory MOE expenditures, and in assessing the need for legislative changes. 2014-12-31-05:00 Active Robert Sargis 2026907275 No No No 54 6372 0

Annual Report on State MOE Programs No Community and Social Services Social Services
ACF-204 Annual Report on State MOE Programs Yes Yes Fillable Fileable Signable Form ACF-204 Report.pdf
State, Local, and Tribal Governments 54 6372 0

OLDC Sytem-Maintenance No Community and Social Services Social Services State, Local, and Tribal Governments 0 0 0

2011-12-28-05:00

0970-0260 201208-0970-003 0970
             
        "Extension to Head Start Transportation Requirements"
             
          
        
This notice of proposed rulemaking seeks to make permanent the opportunity for Head Start grantees to request a waiver of the Head Start Transportation Requirements related to child restraint systems and bus monitors. Head Start grantees were given the opportunity to request a waiver of these requirements through P.L. 109-149 when they could show that compliance with these requirements would result in a significant disruption to the program and the agency could demonstrate that waiving such requirements is in the best interest of the children involved. 2015-09-30-04:00 Active Robert Sargis 2026907275 No No No 275 275 0

Extension to Head Start Transportation Requirements No Community and Social Services Social Services Private Sector 275 275 0

2012-09-18-04:00

0970-0265 201012-0970-005 0970
             
        "ANA Consultant and Evaluator Qualifications Form"
             
          
        
The ANA Consultant and Evaluator Qualifications Form is used to collect data from prospective panel reviewers in compliance with 42 USC Section 2991d-1. The form allows the ANA Commissioner to select qualified people to review grant appllications for: Social & Economic Development, Language Preservation & Environmental Regulation. The review process is a legislative mandate, & respondents are drawn from the public with a legislatively required preference being given to those who are Native: American, Alaskan, Hawiian, & other Native Pacific Islanders. 2014-04-30-04:00 Active Robert Sargis 2026907275 No No No 300 300 0

ANA Consultant and Evaluator Qualifications Form No Community and Social Services Social Services
1 ANA Consultant and Evaluator Qualification Form Yes Yes Fillable Printable Form ANA Consultant and Evaluator Qualifications Form.doc
Individuals or Households 300 300 0

2011-04-11-04:00

0970-0278 201106-0970-007 0970
             
        "Reunification Procedures for Approval for Unaccompanied Alien Children"
             
          
        
Under 6 U.S.C. 279, ACF/ORR is responsible for the care and placement of unaccompanied alien children in Federal custody for immigration proceedings. The proposed information collections requests information to be utilized by ORR for the determining the suitability of a sponsor/respondent for the release of a minor from ORR custody. The proposed instruments are the Sponsor's Agreement to Conditions of Release (ORR R-420 & ORR R-420s), Verification of Release (ORR R-535), Family Reunification Packet (ORR FRP-081), and the Authorization for Release of Information (ORR R-317). 2014-10-31-04:00 Active Robert Sargis 2026907275 No No No 18380 8042 68925

Family Reunification Instruments No Community and Social Services Social Services
FRP-081/FRP-081s Family Reunification Packet No No Paper Only Form and instruction ORR FRP-081s Checklist_(Phase II)_(3March2011).doc FRP-081/FRP-081s Family Reunification Packet No No Paper Only Form and instruction ORR FRP-081s_(Phase II)_(3March2011).doc FRP-081/FRP-081s Reunification Packet No No Paper Only Form and instruction ORR FRP-081 Family Reunification Packet and Checklist_(Phase II)_(3March2011).pdf
Individuals or Households 4595 4595 0

Sponsor's Agreement to Conditions of Release No Community and Social Services Social Services
ORR-420/420s Sponsor's Agreement No No Paper Only Form and instruction Sponsor's Agreement to Conditions of Release (Spanish) Exp 07 31 2011.doc ORR-420/420s Sponsor's Agreement No No Paper Only Form and instruction Sponsor's Agreement to Conditions of Release (English) Exp 07 31 2011.doc
Individuals or Households 4595 1149 68925

Verification of Release No Community and Social Services Social Services
ORR-535/ORR-535s Verification of Release No No Paper Only Form and instruction ORR R-535 Verification of Release_(Phase II)_(3March2011).pdf ORR-535/ORR-535s Authorization for Release No No Paper Only Form and instruction ORR R-535s_Verfication of Release_(Phase II)_(3March2011).doc
Individuals or Households 4595 1149 0

Authorization for Release of Information No Community and Social Services Social Services
ORR-317/ORR-317s Authorization for Release No No Paper Only Form and instruction ORR R-317s_Authorization for Release of Information 1 of 2_(Phase II)_(3March2011).doc ORR-317/ORR-317s Authorization for Release No No Paper Only Form and instruction ORR R-317 Authorization for Release_(Phase II)_(3March2011).pdf ORR-317/ORR-317s Authorization for Release No No Paper Only Form and instruction ORR R-317s_Authorization for Release of Information 2 of 2_(Phase II)_(3March2011).doc
Individuals or Households 4595 1149 0

2011-10-31-04:00

0970-0280 201109-0970-002 0970
             
        "Family Violence Prevention and Services: Grants to States; Native American Tribes and Alaskan Native Villages; and State Domestic Violence Coalitions"
             
          
        
The information that we receive and compile from the annual program reports is used in the development of planning guidance provided to the field, for staff training, program improvement actions, and used in the development of our discretionary programs. 2014-11-30-05:00 Active Robert Sargis 2026907275 No No No 562 5620 0

FVPSA STATE GRANT PROGRAM ANNOUNCEMENT No Community and Social Services Social Services State, Local, and Tribal Governments 53 530 0

FVPSA TRIBAL PROGRAM ANNOUNCEMENT No Community and Social Services Social Services State, Local, and Tribal Governments 200 1000 0

FVPSA STATE COALITION PROGRAM ANNOUNCEMENT No Community and Social Services Social Services
1 PA Yes Yes Paper Only Form and instruction 09 Coalition Announcement Final.doc
State, Local, and Tribal Governments 56 560 0

FVPSA STATE PERFORMANCE REPORT No Community and Social Services Community and Regional Development
1 States and Territories Yes Yes Fillable Printable Form and instruction State PPR.pdf
State, Local, and Tribal Governments 53 530 0

FVPSA TRIBAL PERFORMANCE REPORT No Community and Social Services Social Services
1 Tribal PPR Yes Yes Fillable Printable Form and instruction Tribal PPR.pdf
State, Local, and Tribal Governments 200 3000 0

2011-11-06-05:00

0970-0307 201206-0970-011 0970
             
        "Court Improvement Program-New Grants"
             
          
        
The information being collected is required by the Secretary as a prerequisite to receipt of a grant award. The information submitted will be used by the Children's Bureau to ensure compliance with the program requirements and serve as a basis for the provision of training and technical assistance to the grantee. The application information is provided by a representative of the highest State court of appeal in each State. Annual program reports and financial reports are required. The reports provide updates and changes in goals and activities and indicate how the funds are being used. 2015-08-31-04:00 Active Robert Sargis 2026907275 No No No 104 8944 0

Annual Program Report No Litigation and Judicial Activities Judicial Hearing State, Local, and Tribal Governments 52 4472 0

Application No Litigation and Judicial Activities Judicial Hearing State, Local, and Tribal Governments 52 4472 0

2012-08-07-04:00

0970-0311 201202-0970-003 0970
             
        "Temporary Assistance for Needy Families/National Directory of New Hires Match Results Report"
             
          
        
Section 453(j)(3)of the Social Security Act (the Act) allows for matching between the National Directory of New Hires (maintained by the Federal Office of Child Support Enforcement (OCSE)) and State TANF Agencies for purposes of carrying out responsibilities under programs funded under part A of Title IV of the Act. 2015-03-31-04:00 Active Robert Sargis 2026907275 No No No 48 8 0

NDNH Report Template No Community and Social Services Social Services
1 Match Results Report Yes Yes Printable Only Form and instruction NDNH Report Template.xls
State, Local, and Tribal Governments 48 8 0

2012-03-27-04:00

0970-0320 201309-0970-005 0970
             
        "OCSE-75 Tribal Child Support Enforcement Program Annual Data Report"
             
          
        
The information will be used for monitoring and evaluating tribal child support enforcement programs. 2014-03-31-04:00 Active Robert Sargis 2026907275 No No No 60 3600 0

OCSE-75 No Community and Social Services Social Services
OCSE-75 Annual Report Yes Yes Fillable Printable Form and instruction AT-10-07 issuing OCSE 75 2010.pdf
State, Local, and Tribal Governments 60 3600 0

2013-09-25-04:00

0970-0323 201207-0970-005 0970
             
        "Child Care and Development Fund - Reporting Improper Payments - Instructions for States"
             
          
        
The Improper Payments Information Act of 2002 requires Federal agencies to annually report error rate measures. Section 2 of the Improper Payments Information Act provides for estimates and reports of improper payments by Federal agencies. Subpart K of 45 CFR, Part 98 requires preparation and submission of a report of errors occurring in the administration of CCDF grant funds once every three years. The information collected will be used to prepare the annual Agency Financial Report (AFR) and will provide information necessary to offer technical assistance to grantees. The current collection expires in August 2010. This renewal is to be in place for the continuation of the required review process. 2015-09-30-04:00 Active Robert Sargis 2026907275 No No No 4734 43613 0

Record Review Worksheet No Community and Social Services Social Services
1 Record Review Worksheet Yes Yes Fillable Printable Form and instruction Data Collection Instructions 2012.doc
State, Local, and Tribal Governments 4692 29700 0

Corrective Action Plan No Community and Social Services Social Services
1 Corrective Action Plan Yes Yes Fillable Printable Form and instruction Data Collection Instructions 2012.doc
State, Local, and Tribal Governments 8 1248 0

State Improper Payments Report No Community and Social Services Social Services
1 Appendix B No No Fillable Fileable Form and instruction Data Collection Instructions 2012.doc
State, Local, and Tribal Governments 17 10863 0

Sampling Decisions, Assurances and Fieldwork Preperation Plan No Community and Social Services Social Services
1 Sampling Decisions Yes Yes Fillable Printable Form and instruction Data Collection Instructions 2012.doc
State, Local, and Tribal Governments 17 1802 0

2012-09-18-04:00

0970-0338 201104-0970-006 0970
             
        "DRA TANF Final Rule"
             
          
        
The Deficit Reduction Act of 2005 (DRA) reauthorized the Temporary Assistance for Needy Families (TANF) program and imposed a new data requirement that States prepare and submit data verification procedures and replaced other data requirements with new versions including: the TANF Data Report, the SSP-MOE Data Report, the Caseload Reduction Documentation Process, and the Reasonable Cause/Corrective Compliance Documentation Process. 2014-07-31-04:00 Active Robert Sargis 2026907275 No No No 548 625200 0

Caseload Reduction Documentation Process, AC-202 No Community and Social Services Social Services State, Local, and Tribal Governments 54 6480 0

Preperation and Submission of Data Verification Procedures No Community and Social Services Social Services
1 Work Verification Plan Guidance Yes Yes Printable Only Form and instruction Work_Verification_Plan_Guidance.pdf
State, Local, and Tribal Governments 54 34560 0

Reasonable Cause/Corrective Compliance Process No Community and Social Services Social Services State, Local, and Tribal Governments 108 25920 0

TANF Data Report No Community and Social Services Social Services
3 TANF Data Report 3 Yes Yes Printable Only Form TDR_reports_ssp3.pdf 4 TANF Data Report 4 Yes Yes Printable Only Form TDR_reports_ssp4.pdf 2 TANF Data Report 2 Yes Yes Printable Only Form TDR_reports_ssp2.pdf 1 Tanf Data Report 1 Yes Yes Fillable Printable Form TDR_reports_ssp1.pdf
State, Local, and Tribal Governments 216 475416 0

SSP-MOE Data Report No Community and Social Services Social Services
4 MOE Report 4 Yes Yes Fillable Printable Form ssprpt4frev.pdf 3 MOE Report 3 Yes Yes Fillable Printable Form ssprpt3f.pdf 2 MOE Report 2 Yes Yes Fillable Printable Form ssprpt2f.pdf 1 MOE Report 1 Yes Yes Fillable Printable Form sspmoerpt1.xls
State, Local, and Tribal Governments 116 82824 0

2011-07-24-04:00

0970-0340 201210-0970-006 0970
             
        "National Youth in Transition Database (NYTD) and Youth Outcomes Survey - Final Rule"
             
          
        
The Foster Care Independence Act of 1999 (42 U.S.C. 1305 et seq.) as amended by Public Law 106-169 requires State child welfare agencies to collect and report to the Administration on Children and Families (ACF) data on the characteristics of youth receiving independent living services and information regarding their outcomes. The regulation implementing the National Youth in Transition Database, listed in 45 CFR 1356.80, contains standard data collection and reporting requirements for States to meet the law's requirements. ACF will use the information collected under the regulation to track independent living services, assess the collective outcomes of youth, and potentially to evaluate State performance with regard to those outcomes consistent with the law's mandate. 2016-02-29-05:00 Active Robert Sargis 2026907275 No No No 15438 132571 6500000

Youth Outcome Survey No Community and Social Services Social Services Individuals or Households 15334 7667 0

Data File No Community and Social Services Social Services State, Local, and Tribal Governments 104 124904 6500000

2013-02-01-05:00

0970-0342 201106-0970-006 0970
             
        "Information Comparision with Insurance Data"
             
          
        
The Deficit Reduction Act of 2005 amended Section 452 of the Social Security Act (the Act) to authorize the Secretary of Health and Human Services, through the Federal Parent Locator Service (FPLS), to conduct comparisons of information concerning individuals owing past-due child support with information maintained by insurance companies (or their agents) concerning insurance claims, settlements, awards, and payments. The Federal Office of Child Support Enforcement (OCSE) operates the FPLS in accordance with section 453(a)(1) of the Act. The Federal Case Registry of Child Support Orders (FCR) is maintained in the FPLS and contains all State caseloads in accordance with section 453(h)(1) of the Act. At the option of an insurer, the comparison may be accomplished by either of the following methods: under the first method, an insurer or the insurer's agent will submit to OCSE information concerning claims, settlements, awards, and payments. OCSE will then compare that information with information pertaining to individuals owing past-due support; under the second method, OCSE will furnish to the insurer or the insurer's agent a file containing information pertaining to individuals owing past-due support. The insurer or the insurer's agent will then compare that information with information pertaining to claims, settlements, awards, and payments. The insurer will furnish the information resulting from the comparison to OCSE. On a daily basis, OCSE will furnish the results of the comparison to the State CSE agencies responsible for collecting the past-due child support by transmitting the Insurance Match Response Record via the FCR. The results of the comparison will be used by the State agencies to collect past-due child support from the insurance proceeds. This match is optional for both States and insurers or their agents. 2014-09-30-04:00 Active Robert Sargis 2026907275 No No No 286 143 3526

Components of an Insurance Match Agreement No Community and Social Services Social Services
1 Insurance Match Agreement Yes Yes Fillable Printable Form and instruction Components of Insurance Match Agreement 8-1-06.doc
Private Sector 22 11 1320

Insurance Match File No Community and Social Services Social Services
1 Match File Yes Yes Fillable Fileable Form and instruction 01 Standard Input File 08-03-07.doc
Private Sector 264 132 2206

2011-09-05-04:00

0970-0345 201302-0970-005 0970
             
        "Tribal TANF Financial Report (ACF-196T)"
             
          
        
Tribes use the Quarterly Financial Report (ACF-196T) to report expenditures on a quarterly basis for the Tribal Temporary Assistance for needy families (TANF) program. The form provides specific data regarding financial disbursements and obligations. Failure to collect this data would seriously compromise the Administration for Children and Families ability to monitor expenditures. Data from this form may be used to prepare ACF budget submissions to Congress. 2016-05-31-04:00 Active Robert Sargis 2026907275 Yes No No 288 432 0

ACF-196T Tribal TANF Report Form No Community and Social Services Social Services
Yes Yes Paper Only Instruction Program Instruction ACF-196T.doc 1 Expenditure Report 196T Yes Yes Paper Only Form Report Form - ACF 196T with ARRA Column.xls
State, Local, and Tribal Governments 288 432 0

2013-05-10-04:00

0970-0348 201108-0970-010 0970
             
        "LIHEAP REACH Model Plan"
             
          
        
The REACH Model Plan will be used for annual applications to receive Federal funds. 2014-10-31-04:00 Active Robert Sargis 2026907275 No No No 51 3672 35700

Model Plan No Community and Social Services Social Services
1 Model Plan Yes Yes Fillable Printable Form and instruction reach model plan 11.doc
State, Local, and Tribal Governments 51 3672 35700

2011-10-23-04:00

0970-0351 201111-0970-008 0970
             
        "State Plan for Grants to States for Refugee Resettlement"
             
          
        
Description: A State Plan is required by 8 U.S.C. Sec. 1522 of the Immigration and Nationality Act (the Act) [Title IV, Sec. 412 of the Act] for each State agency requesting Federal funding for refugee resettlement under 8 U.S.C. Sec. 1524 [Title IV, Sec. 414 of the Act], including Refugee Cash and Medical Assistance, Refugee Social Services, and Targeted Assistance program funding. The State Plan is a comprehensive narrative description of the nature and scope of a State's programs and provides assurances that the programs will be administered in conformity with the specific requirements stipulated in 45 CFR 400.4-400.9. The State Plan must include all applicable State procedures, designations, and certifications for each requirement as well as supporting documentation. A State may use a pre-print format prepared by the Office of Refugee Resettlement (ORR) of the Administration for Children and Families (ACF) or a different format, on the condition that the format used meets all of the State plan requirements under Title IV of the Act and ORR regulations at 45 CFR part 400. Respondents: State Agencies, Replacement Designees under 45 CFR 400.301(c), and Wilson-Fish Grantees (State Agencies) administering or supervising the administration of programs under Title IV of the Act. 2014-12-31-05:00 Active Robert Sargis 2026907275 No No No 50 750 0

State Plan for Grants to States for Refugee Resettlement No Community and Social Services Social Services
1 State Plan Approval Check List Yes Yes Fillable Fileable Form and instruction State Plan Approval Checklist (2).doc
State, Local, and Tribal Governments 50 750 0

2011-12-28-05:00

0970-0353 201111-0970-009 0970
             
        "Regional Partnership Grant (RPG) Program Data Collection"
             
          
        
This is a performance management system mandated by the Child and Family Services Improvement Act of 2006. 2014-12-31-05:00 Active Robert Sargis 2026907275 No No No 86 15093 147318

State, Local or Tribal No Community and Social Services Social Services
Yes Yes Fillable Printable Instruction Final Data Submission Plans Instructions 2011.docx 0 survey Yes Yes Fillable Printable Form Data Plan Sample.pdf No No Paper Only Other RPG Data Dictionary.pdf
State, Local, and Tribal Governments 52 9126 89076

Private Sector No Community and Social Services Social Services
No No Paper Only Other RPG Data Dictionary.pdf 0 survey Yes Yes Fillable Printable Form Data Plan Sample.pdf
Private Sector 34 5967 58242

2011-12-28-05:00

0970-0355 201402-0970-001 0970
             
        "Pre-testing of Evaluation Surveys"
             
          
        
To date the Administration for Children and Families (ACF), Office of Planning Research and Evaluation (OPRE), has relied on small field tests (involving fewer than ten respondents) in developing questionnaires. However, these small tests are limited in their ability to detect and diagnose problems with the instruments and the procedures being tested. In response to this problem, we request a generic survey development clearance to allow us to use larger samples in applying methods useful for identifying questionnaire and procedural problems, suggesting solutions, and measuring the relative effectiveness of alternative solutions. 2015-01-31-05:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 4000 2000 0

Quality of Family-Provider Relationships in Early Care and Education No Community and Social Services Social Services Individuals or Households 162 235 0

Permanency Innovations Initiative - LA RISE No Community and Social Services Social Services Private Sector 1000 300 0

Permanency Innovations Initiative - AZ, CAPP, IL No Community and Social Services Social Services Individuals or Households 422 521 0

Head Start Family Voices Pilot Study No Community and Social Services Social Services Individuals or Households 380 341 0

Measurement Development: Quality of Family-Provider Relationships in Early Care and Education No Community and Social Services Social Services Individuals or Households 45 37 0

Redesign of the Head Start Family and Child Experiences Survey (FACES 2012) No Community and Social Services Social Services Individuals or Households 958 185 0

Q-DOT Pilot Study No Community and Social Services Social Services Individuals or Households 60 20 0

2014-02-06-05:00

0970-0356 201305-0970-007 0970
             
        "Formative Data Collections for Informing Policy Research"
             
          
        
In order to inform the development of OPRE research, to maintain a research agenda that is rigorous and relevant, and to ensure that research products are as current as possible, OPRE will engage in a variety of formative data collections in concert with researchers and practitioners throughout the field. OPRE envisions using a variety of techniques including semi-structured discussions, focus groups, telephone interviews, and in-person site visits, in order to integrate the perspectives of program operators, policy officials and members of the research community. 2015-01-31-05:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 1600 1600 0

Street Outreach Program Data Collection Project No Community and Social Services Social Services Individuals or Households 880 1100 0

ACF Behavioral Interventions to Advance Self-Sufficiency (BIAS) Project No Community and Social Services Social Services Individuals or Households 156 156 0

2013-05-28-04:00

0970-0362 201108-0970-008 0970
             
        "Request for Assistance for Child Victims of Human Trafficking"
             
          
        
The TVPRA 2008 directs HHS upon receipt of credible information that a non-U.S. citizen, non-lawful permanent resident (alien) child may have been subjected to a severe form of trafficking in persons and is seeking Federal assistance available to victims of trafficking, to promptly determine if the child is eligble for interim assistance. The law further directs HSS to determine if the child is eligble for assistance as a victim of a severe form of trafficking in persons after consultation with the Attorney General, the Secretary of Homeland Security, and nongovernmental organizations with expertise on victims of severe form of trafficking. In developing procedures for collecting the neccessary informaiton from potential child victims of trafficking, their case managers, attorneys, or other representatives to allow HHS to grant interim eligbility, HHS devised a form. HHS has determined that the use of a standard form to collect iformation is the best way to ensure requestors are notified of their option to request assistance for child victims of trafficking and to make prompt and consistent determinations about the child's eligbility for interim assistance. Specifcially, the form asks the requestor for his/her identifying information, for information on the child, information describing the type of trafficking and circumstances surrounding the situation, and the strengths and needs of the child. The form also asks the requestor to verify the information contained in the form becuase the information could be the basis for a determination of an alien child's eligibiltiy for federally funded benefits. Finally, the form takes into consideration the need to compile information regarding a child's circumstances and experiences in a non-directive, child-friendly way, and assists the potential requestor in assessing whether the child may have been subjected to trafficking in persons. 2014-12-31-05:00 Active Robert Sargis 2026907275 No No No 200 200 0

Request for Assistance for Child Victims of Human Trafficking No Community and Social Services Community and Regional Development
1 Request for Assistance Yes Yes Fillable Printable Form and instruction Attachment B - Request for Assistance form.pdf
Individuals or Households 200 200 0

2011-12-12-05:00

0970-0364 201305-0970-003 0970
             
        "HHS/ACF/OPRE Head Start Classroom-based Approaches and Resources for Emotion and Social skill promotion (CARES) project: Tracking Participants"
             
          
        
The Office of Planning, Research and Evaluation (OPRE) of the Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is submitting the Request for OMB Review in support of an ongoing project to collect contact and follow-up information from children and families who participated in the Head Start Classroom-based Approaches and Resources for Emotion and Social skill promotion (CARES) project. The Head Start CARES project is a group-randomized trial of three social-emotional program enhancements within a diverse set of nationally representative Head Start classrooms. In anticipation of conducting a large-scale Head Start CARES follow-up during the fourth grade and to ensure high response rates for such a follow-up study, ACF would like to continue contacting and tracking families for three years for the Head Start CARES Project: Tracking Participants. Currently, we are seeking OMB approval for three years of data collection from summer 2013 through spring 2016. 2016-08-31-04:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 3752 1876 0

HHS/ACF/OPRE Head Start Classroom-based Approaches and Resources for Emotion and Social skill promotion (CARES) project: Impact and Implementation Studies- Teacher Report on Individual Children No Community and Social Services Social Services Individuals or Households 0 0 0

HHS/ACF/OPRE Head Start Classroom-based Approaches and Resources for Emotion and Social skill promotion (CARES) project: Impact and Implementation Studies- Follow-up Parent Survey No Community and Social Services Social Services Individuals or Households 0 0 0

Parent Survey Cohort 1 (4-year-olds) No Community and Social Services Social Services Individuals or Households 402 201 0

Parent Survey Cohort 2 (4-year-olds) No Community and Social Services Social Services Individuals or Households 2070 1035 0

Parent Survey Cohort 2 (3-year-olds) No Community and Social Services Social Services Individuals or Households 1280 640 0

2013-08-06-04:00

0970-0365 201206-0970-005 0970
             
        "Performance Measures for Healthy Marriage and Promoting Responsible Fatherhood Grants"
             
          
        
The information collection is necessary for OFA and the Administration for Children and Families (ACF) to ensure the accountability and performance of these grants programs. The grant solicitations issued by the Administration for Children and Families require the grantees to participate in data collection. Specifically, the grant announcements state, "[a]ll grantees will participate fully in quantitative or monitoring activities that capture measurable indicators and outcomes. ACF will require a consistent measuring system across all funded programs." 2015-08-31-04:00 Active Robert Sargis 2026907275 No No No 236 189 0

Private Sector No Community and Social Services Social Services
1 Comment Yes Yes Fillable Printable Form and instruction Attach G_Comment Sheet1.doc 1 RF Combined Yes Yes Fillable Printable Form and instruction Attach E_RF Performance_Combined1.pdf 1 HM Combined Yes Yes Fillable Printable Form and instruction Attach C_HM Performance_Combined1.pdf
Private Sector 206 165 0

Public Sector No Community and Social Services Social Services
1 RF Combined Yes Yes Fillable Printable Form and instruction Attach E_RF Performance_Combined1.pdf 1 HM Combined Yes Yes Fillable Printable Form and instruction B - HM Combined OMB.pdf 1 Comment Yes Yes Fillable Printable Form and instruction Attach G_Comment Sheet1.doc
State, Local, and Tribal Governments 30 24 0

2012-08-07-04:00

0970-0366 201208-0970-006 0970
             
        "Emergency Contingency Fund for Temporary Assistance for Needy Families (TANF) Programs"
             
          
        
On February 17, 2009, the President signed the American Recovery and Reinvestment Act of 2009 (Recovery Act), which establishes the Emergency Contingency Fund for State TANF Programs (Emergency Fund) as section 403(c) of the Social Security Act (the Act). This legislation provides up to $5 billion to help States, Territories, and Tribes in fiscal year (FY) 2009 and FY 2010 that have an increase in assistance caseloads and basic assistance expenditures, or in expenditures related to short-term benefits or subsidized employment. The Recovery Act made additional changes to TANF * extending supplemental grants through FY 2010, expanding flexibility in the use of TANF funds carried over from one fiscal year to the next, and adding a hold-harmless provision to the caseload reduction credit for States and Territories serving more TANF families. The Emergency Fund is intended to build upon and renew the principles of work and responsibility that underlie successful welfare reform initiatives. The Emergency Fund provides resources to States, Territories, and Tribes to support work and families during this difficult economic period. We plan to issue a Program Instruction accompanied by the Emergency Fund Request Form (OFA-100), and instructions for jurisdictions to complete the OFA-100 to apply for emergency funds. Failure to collect this data would compromise ACF's ability to monitor caseload and expenditure data that must increase in order for jurisdictions to receive awards under the Emergency Fund. Documentation maintenance on financial reporting for the Emergency Fund is governed by 45 CFR 92.20 and 45 CFR 92.42. 2015-10-31-04:00 Active Robert Sargis 2026907275 Yes No No 18 432 0

OFA-100 No Community and Social Services Social Services
1 OFA-100 Yes Yes Fillable Fileable Form OFA-100 form.doc
State, Local, and Tribal Governments 18 432 0

2012-10-02-04:00

0970-0370 201208-0970-004 0970
             
        "FPLS Portal Registration"
             
          
        
The Federal Office of Child Support Enforcement (OCSE) is implementing the Federal Parent Locator Service (FPLS) Child Support Services Portal (FCSSP) for users of the FPLS to access online web applications. The portal Registration Process will provide OCSE, States, employers and multistate financial institutions the ability to create a secure account to view data for their respective applications. In order for users to access the portal, registration is required. 2015-10-31-04:00 Active Robert Sargis 2026907275 No No No 588 59 0

FPLS Child Support Services Portal Registration No Community and Social Services Community and Regional Development
1 Portal Registration Yes Yes Fillable Printable Form and instruction FSF User Screen Flow v2_053112.doc
State, Local, and Tribal Governments 588 59 0

2012-10-02-04:00

0970-0371 201208-0970-002 0970
             
        "Cross-site Evaluation of the Infant Adoption Training Program"
             
          
        
The proposed information collection will be conducted for national cross-site evaluation purposes. All IAATP grantees are required, as a condition of receiving funding, to participate in a national cross-site evaluation. National evaluation activities are designed to assess objectively the knowledge and skills gained, retained and applied by trainees as a result of ther participation in the Infant Adoption Awareness Training Program. 2015-09-30-04:00 Active Robert Sargis 2026907275 No No No 2400 300 0

Pre-Test No Community and Social Services Social Services
1 Pre-Test Yes Yes Fillable Printable Form and instruction Backup of IAATPSurvey-PreTest-OMB.wbk
Individuals or Households 1200 180 0

Follow-up Survey No Community and Social Services Social Services
1 Post Test Yes Yes Fillable Fileable Form and instruction DRAFT-IAATPSurvey-FollowUp-OMB.doc
Individuals or Households 1200 120 0

2012-09-18-04:00

0970-0373 201306-0970-002 0970
             
        "Project LAUNCH Cross-Site Evaluation"
             
          
        
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval for collection of data from an additional fourth cohort of 11 cooperative agreements funded in September 2012 for the cross-site evaluation of Project LAUNCH (Linking Actions for Unmet Needs in Children's Health). The request to collect data from these 11 cooperative agreements is in addition to OMB-approved data collection at 24 cooperative agreements funded by the Substance Abuse and Mental Health Services Administration (SAMHSA) under Project LAUNCH (OMB Control# 0970-0373): 6 cooperative agreements in September 2008 (Cohort 1), 12 additional cooperative agreements in September 2009 (Cohort 2), and 6 more cooperative agreements in September 2010 (Cohort 3). Data collection for Cohort 4 (funded September 2012) grantees will follow the same schedule as the other Cohorts. 2016-09-30-04:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 264 1000 0

Site Visit and Telephone Interview Guide No Community and Social Services Social Services Individuals or Households 0 0 0

Electronic Data Reporting: Systems Measures No Community and Social Services Social Services Individuals or Households 54 216 0

Electronic Data Reporting: Services Measures No Community and Social Services Social Services Individuals or Households 54 432 0

Child Wellness Coordinator Interview Guide No Community and Social Services Social Services Individuals or Households 27 41 0

Chair of Local Child Wellness Council Interview Guide No Community and Social Services Social Services Individuals or Households 19 19 0

Local Stakeholder Interview Guide No Community and Social Services Social Services Individuals or Households 57 43 0

State Child Wellness Coordinator Interview Guide No Community and Social Services Social Services Individuals or Households 16 20 0

Chair of State Child Wellness Council Interview Guide No Community and Social Services Social Services Individuals or Households 10 13 0

Outcomes Data Tables in End of Year Reports No Community and Social Services Social Services Individuals or Households 27 216 0

2013-09-09-04:00

0970-0374 201211-0970-003 0970
             
        "Head Start Eligibility Verification"
             
          
        
The requirements for establishing proof of eligibility for the enrollment of children in Head Start programs are documented in 45 CFR 1305.4 (e). The regulation states that each child's record must include a signed document by an employee identifying those documents which were reviewed to determine eligibility and stating that the child is eligible to participate in the program. Presently there is no standardized document for grantees to use. This form will be used to facilitate an efficient and accurate determination and documentation of childrens' eligibility for Head Start. 2016-02-29-05:00 Active Robert Sargis 2026907275 No No No 1200000 96000 0

Head Start Eligibility Verfication Form No Community and Social Services Social Services
0 Head Start Eligibility Verification Yes Yes Fillable Printable Form and instruction HS eligibiliy verification form 10 20 09.DOC
Individuals or Households 1200000 96000 0

2013-02-07-05:00

0970-0377 201302-0970-004 0970
             
        "Cross-site Evaluation of the Children's Bureau's Child Welfare Technical Assistance Implementation Centers and National Child Welfare Resource Centers"
             
          
        
The proposed information collection is necessary to track, monitor, and evaluate the activities of Federally-funded training and technical assistance providers that deliver services to State, local, Tribal, and other publicly administered or publicly supported child welfare agencies and family and juvenile courts. The proposed data collection instruments for review are: the Agency Results Survey, T/TA Activity Survey, Network Web-Based Survey, and seven forms that are part of the OneNet data system. 2016-05-31-04:00 Active Robert Sargis 2026907275 No No No 6201 1869 0

Agency Results Survey No Community and Social Services Social Services
1 Agency Results Survey Yes Yes Fillable Fileable Form and instruction Agency Results Survey_5_14.doc
State, Local, and Tribal Governments 0 0 0

Training and Technical Assistance (T/TA) Activity Survey No Community and Social Services Social Services
1 Training and Technical Assistance Activity Survey Yes Yes Fillable Fileable Form and instruction Training and Technical Assistance TTA Activity Survey_5_141 (3).doc
State, Local, and Tribal Governments 0 0 0

Web-based Network Survey No Community and Social Services Social Services
1 Web-based Network Survey Yes Yes Fillable Fileable Form and instruction Web-Based Network Survey_5_14 (2).doc
Private Sector 0 0 0

General T/TA Event No Community and Social Services Social Services
1 General T/TA Event Yes Yes Fillable Fileable Form and instruction General TTA Event Form.pdf
Private Sector 0 0 0

NRC T/TA Work Plan No Community and Social Services Social Services
1 NRC T/TA Work Plan Yes Yes Fillable Fileable Form and instruction NRC TTA Work Plan Form.pdf
Private Sector 0 0 0

NRC T/TA Close-Out No Community and Social Services Social Services
1 NRC T/TA Close Out Yes Yes Fillable Fileable Form and instruction NRC TTA Close-Out Form.pdf
Private Sector 0 0 0

NRC T/TA Activity No Community and Social Services Social Services
1 NRC T/TA Activity Yes Yes Fillable Fileable Form and instruction NRC TTA Activity Form.pdf
Private Sector 0 0 0

Implementation Project Monthly Report No Community and Social Services Social Services
1 Implementation Project Monthly Report Yes Yes Fillable Fileable Form and instruction Implementation Project Monthly Report Form.pdf
Private Sector 0 0 0

Implementation Project Information No Community and Social Services Social Services
1 Implementation Project Information Yes Yes Fillable Fileable Form and instruction Implementation Project Information Form.pdf
Private Sector 0 0 0

Implementation Project T/TA Activity No Community and Social Services Social Services
1 Implementation Project T/TA Activity Yes Yes Fillable Fileable Form and instruction Implementation Project TTA Activity Form.pdf
Private Sector 0 0 0

Agency Results Survey No Community and Social Services Social Services
1 Agency Results Survey Yes Yes Fillable Printable Form and instruction 1_Agency Results Survey 9-27-12.pdf
State, Local, and Tribal Governments 74 74 0

Training and Technical Assistance (T/TA) Activity Survey No Community and Social Services Social Services
1 TTA Activity Survey (Respondent Type 2 Yes Yes Fillable Printable Form and instruction 2c_TTA Activity Survey (Respondent Type 2).pdf 1 TTA Activity Survey (Respondent Type 1 Yes Yes Fillable Printable Form and instruction 2b_TTA Activity Survey (Respondent Type 1).pdf 1 TTA Activity Survey Introduction Yes Yes Fillable Printable Form and instruction 2a_TTA Activity Survey Introduction.pdf
Individuals or Households 480 120 0

Web-based Network Survey No Community and Social Services Social Services
1 Web Based Survey Yes Yes Fillable Printable Form and instruction 3_Web-Based Network Survey.pdf
Private Sector 15 4 0

OneNet Form: General T/TA Event Form No Community and Social Services Social Services
1 OneNet Form-General TTA Event Form Yes Yes Fillable Fileable Form and instruction 4_OneNet Form - General TTA Event Form.pdf
Private Sector 201 50 0

One Net Form: T/TA Assessment & Work Plan Form No Community and Social Services Social Services
1 OneNet Form: Implementation Project Assessment and Work Plan Form Yes Yes Fillable Printable Form and instruction 9_OneNet Form - Implementation Project Assessment and Work Plan Form.pdf
Private Sector 81 23 0

One Net Form: T/TA Request Form No Community and Social Services Social Services
1 T/TA Request Form Yes Yes Fillable Printable Form and instruction 5_OneNet Form - TTA Request Form.pdf
Private Sector 160 64 0

OneNet Form: T/TA Activity Form No Community and Social Services Social Services
1 T/TA Activity Form Yes Yes Fillable Printable Form and instruction 7_OneNet Form - TTA Activity Form.pdf
Private Sector 1920 576 0

One Net Form: Implementation Project Monthly Report Form No Community and Social Services Social Services
1 OneNet: Implementation Project Monthly Report Form Yes Yes Fillable Printable Form and instruction 11_OneNet Form - Implementation Project Monthly Report Form.pdf
Private Sector 180 31 0

OneNet Form: Implementation Project Assessment & Work Plan Form No Community and Social Services Social Services
1 OneNet: Implementation Project Assessment and Work Plan Form Yes Yes Fillable Fileable Form and instruction 9_OneNet Form - Implementation Project Assessment and Work Plan Form.pdf
Private Sector 81 23 0

One Net Form: Implementation Project T/TA Activity Form No Community and Social Services Social Services
1 OneNet: TTA Activity Form Yes Yes Fillable Printable Form and instruction 7_OneNet Form - TTA Activity Form.pdf
Private Sector 3000 900 0

One Net Form: Implementation Project Application Form No Community and Social Services Social Services
1 One Net: Implementation Project Application Form Yes Yes Fillable Printable Form and instruction 8_OneNet Form - Implementation Project Application Form.pdf
State, Local, and Tribal Governments 9 4 0

2013-05-15-04:00

0970-0379 201305-0970-002 0970
             
        "ANA Project Impact Assessment Survey"
             
          
        
The information collected by the Project Impact Assessment Survey is needed for two main reasons: 1) to collect crucial information required to report on the Administration for Native Americans' (ANA) established Government Performance and Results Act (GPRA) measures, and 2) to properly abide by ANA's congressionally-mandated statute (42 United States Code 2991 et seq.) found within the Native American Programs Act of 1974, as amended, which states that ANA will evaluate projects assisted through ANA grant dollars "including evaluations that describe and measure the impact of such projects, their effectiveness in achieving stated goals, their impact on related programs, and their structure and mechanisms for delivery of services." The information collected with this survey will fulfill ANA's statutory requirement and will also serve as an important planning and performance tool for ANA. 2016-08-31-04:00 Active Robert Sargis 2026907275 No No No 85 510 0

Project Impact Survey No Community and Social Services Community and Regional Development
1 Project Assessment Tool Yes Yes Fillable Printable Form and instruction ACF-ANA-Project-Impact-Assessment Tool.pdf
State, Local, and Tribal Governments 85 510 0

2013-08-27-04:00

0970-0380 201310-0970-001 0970
             
        "(PREP) State Personal Responsibility Program"
             
          
        
OMB approval is requested for the application requirements and a program related document for the awarded States and Territories. The Personal Responsibility Education Program (PREP), was initiated when the President signed into law the Patient Protection and Affordable Care Act on March 23, 2010. This act adds a new formula grant program, section 513, to Title V of the Social Security Act (42 U.S.C. 701 et seq) as amended by sections 2951 and 2952(c). Pursuant to the Act, "Personal Responsibility Education," for purposes of this program means a program to educate adolescents on both abstinence and contraception to prevent pregnancy and sexually transmitted infections (STIs); and at least three adulthood preparation subjects. The application collection tool includes five components that require OMB approval in order to determine if the applicant has an understanding and the resources to implement PREP. 2017-01-31-05:00 Active Robert Sargis 2026907275 No Yes No 172 2752 0

Application No Community and Social Services Social Services State, Local, and Tribal Governments 0 0 0

State Plan No Community and Social Services Social Services State, Local, and Tribal Governments 0 0 0

Performance Progress Report No Community and Social Services Social Services
1 PPR Yes Yes Fillable Printable Form and instruction
State, Local, and Tribal Governments 172 2752 0

2014-01-09-05:00

0970-0381 201309-0970-007 0970
             
        "State Abstinence Education Program"
             
          
        
The Family and Youth Services Bureau (FYSB) is accepting applications from States and Territories for the development and implementation of the State Abstinence Program. The purpose of this program is to support decisions to abstain from sexual activity by providing abstinence programming as defined by Section 510(b) of the Social Security Act (42U.S.C. 710(b)) with a focus on those groups that are most likely to bear children out-of-wedlock, such as youth in or aging out of foster care. The State Abstinence Program was extended through FY2014 under the Patient Protection and Affordable Care Act of 2010, Pub. L. 111-148. 2016-10-31-04:00 Active Robert Sargis 2026907275 No Yes No 162 4820 0

Abstinence Education Program Application No Community and Social Services Social Services
1 application Yes Yes Fillable Printable Form and instruction
State, Local, and Tribal Governments 24 480 0

Abstinence Education State Plan No Community and Social Services Social Services
ACF Abstinence Education - Deliberative Document. Yes Yes Fillable Fileable Form and instruction
State, Local, and Tribal Governments 20 800 0

Abstinence Education Program Performance Progress Report No Community and Social Services Social Services
1 Performance Report Yes Yes Fillable Fileable Form and instruction
State, Local, and Tribal Governments 118 3540 0

2013-10-30-04:00

0970-0382 201305-0970-011 0970
             
        "Community Services Block Grant (CSBG) Program Model Plan Applications"
             
          
        
The CSBG Model Plan Application will be used as the plan submitted to ACF by States, Territories, Tribes and Tribal Organizations for the receipt of Federal funds to administer a CSBG program. The information collected is required by the CSBG Statute for the receipt of CSBG program funds. 2016-08-31-04:00 Active Robert Sargis 2026907275 No No No 86 860 0

CSBG Model Plan Application - States and Territories No Community and Social Services Social Services
1 application Yes Yes Fillable Printable Form 8- 2010 OMB approved Outline for Model CSBG state Application (4) (2).docx
State, Local, and Tribal Governments 56 560 0

CSBG Model Plan Application - Tribes and Tribal Governments No Community and Social Services Social Services
1 application Yes Yes Fillable Printable Form 8-2010 OMB approved Outline for Model CSBG Tribal Application (2) (4) (3).docx
State, Local, and Tribal Governments 30 300 0

2013-08-19-04:00

0970-0385 201011-0970-003 0970
             
        "Request for Specific Consent to Juvenile Court Jurisdiction"
             
          
        
The collection of this information is needed so that ACF/ORR can recieve offiical notification by attorneys and representatives of UAC of a plannned SIJ Status action in a state court which may result in a determinination by the state court that the UAC in ORR custody will be subject to the jurisdiction of the state juvenile court. The information collection asks for the name and contact information of the UAC's attorney or representative; the UAC's biographical information; and brief explanation of why the attorney or representative is requesting that a UAC be placed in the jurisdiction of the state juvenile court. The attorney or representative is also required to attach with the request a copy a G-28, EOIR-28 or EOIR-29, or other form of authorization to act on behalf of the unaccompanied alien child. 2014-03-31-04:00 Active Robert Sargis 2026907275 No No No 72 24 0

Request for Specific Consent to Junenile Court Jurisdiction No Litigation and Judicial Activities Judicial Hearing
1 Interim Request for Specific Consent to Juvenile Court Jurisdiction Yes Yes Printable Only Form and instruction Specific Consent FORM INTERIM (9).doc
Private Sector 72 24 0

2011-03-14-04:00

0970-0386 201012-0970-002 0970
             
        "Office of Community Services (OCS) Community Economic Development (CED) and Job Opportunities for Low-Income (JOLI) Standard Reporting Forms"
             
          
        
The Office of Community Services (OCS) is collecting key information about projects funded through the Community Economic Development (CED) and Job Opportunities for Low-Income Individuals (JOLI) programs. The legislative requirement for these two programs is in Title IV of the Community Opportunities, Accountability and Training and Educational Services Act (COATS Human Services Reauthorization Act) of October 27, 1998, Public Law 105-285, section 680(b) as amended. The Performance Progress Report (PPR) is a new proposed reporting format that will collect information concerning the outcomes and management of CED and JOLI projects. OCS will use the data to critically review the overall design and effectiveness of each program. The PPR will be administered to all active grantees of the CED and JOLI programs twice a year. Grantees will be required to use this reporting tool for their semiannual reports. The majority of the questions in this tool were adapted from a previously approved questionnaire, Office of Management and Budget (OMB) Control Number: 0970-0317. Questions were also adapted to the OMB-approved reporting format of the PPR, specifically forms SF-PPR, SF-PPR-A, SF-PPR-B, and SF-PPR-E. Additional changes were made to improve the clarity and quality of the data and to eliminate unnecessary questions. The PPR will replace both the annual questionnaire and the current semiannual reporting format, which will result in an overall reduction in burden for the grantees while significantly improving the quality of the data collected by OCS. 2014-04-30-04:00 Active Robert Sargis 2026907275 No No No 420 630 0

Community Economic Development No Community and Social Services Social Services
1 CED Performance Progress Report Yes Yes Fillable Fileable Form and instruction 2ndFRNotice-CED Performance Progress report.doc
Private Sector 340 510 0

Job Opportunities for Low-Income Individuals (JOLI) No Community and Social Services Social Services
1 JOLI Performance Progress Report Yes Yes Fillable Printable Form and instruction 2ndFRNotice-JOLI Performance Progress Report.doc
Private Sector 80 120 0

2011-04-11-04:00

0970-0388 201302-0970-006 0970
             
        "Tracking of Participants in the Early Head Start Research and Evaluation Project"
             
          
        
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval for a three-year clearance to conduct tracking of children/families who participated in the Early Head Start Research and Evaluation Project (EHSREP). The purpose of tracking these participants is to maintain up-to-date contact information for the children/families in the event that ACF determines that a future follow-up to the EHSREP will take place. 2016-06-30-04:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 3100 678 0

Tracking Survey No Community and Social Services Social Services Individuals or Households 2533 633 0

Administrative Records Consent Form No Community and Social Services Social Services Individuals or Households 567 45 0

2013-06-05-04:00

0970-0390 201103-0970-004 0970
             
        "Strengthening Communitites Fund (SCF) Performance Management and Evaluation Support"
             
          
        
This proposed information collection activity is to obtain information from 84 grantees in two Strengthening Communities Fund (SCF) programs: the Nonprofit Capacity Building Program and the State, Local, and Tribal Government Capacity Building Program. The SCF evaluation is an important opportunity to examine outcomes achieved by the Strengthening Communities Fund and progress toward the objective of improving the capacity of organizations served by program grantees to address broad economic recovery issues in their communities. 2014-07-31-04:00 Active Robert Sargis 2026907275 Yes No No 1168 647 0

SCF Grantee Survey No Community and Social Services Social Services
1 SCF Grantee Questionaire Yes Yes Printable Only Form and instruction Appendix A - SCF Grantee Survey.doc
Private Sector 84 21 0

FBCO Survey No Community and Social Services Social Services
1 FBCO survey Yes Yes Printable Only Form and instruction Appendix B - SCF Faith-based And Community Organization Survey.doc
Private Sector 1000 500 0

SCF Grantee Telephone Interview No Community and Social Services Social Services
1 SCF Phone Interview Guide Yes Yes Printable Only Form and instruction Appendix C - SCF Grantee Telephone Interview Guide.doc
Private Sector 84 126 0

2011-07-21-04:00

0970-0393 201106-0970-002 0970
             
        "AFI Financial Education Practices and Cost Study"
             
          
        
This collection includes information provided to the Administation for Children and Families by grantees in the Financial Education Practices among Assets for Independence (AFI) program. 2014-09-30-04:00 Active Robert Sargis 2026907275 No No No 372 444 0

AFI Financial Education Practices Study No Community and Social Services Social Services
1 AFI Financial Eduation Practices Study Yes Yes Fillable Fileable Form and instruction IC1 AFI Financial Education Practices survey instrument 31 May 2011.docx
Private Sector 300 300 0

AFI Grantee Financial Practices Cost STudy No Community and Social Services Social Services
1 AFI Grantee Financial Practives Cost Study Yes Yes Fillable Fileable Form and instruction IC2 IC3 AFI Financial Education Cost data instrument 31 May 2011 .pdf
Private Sector 30 60 0

AFI SubGrantee Financial Practices Cost Study No Community and Social Services Social Services
1 AFI SubGrantee Financial Practices Cost Study Yes Yes Fillable Fileable Form and instruction IC2 IC3 AFI Financial Education Cost data instrument 31 May 2011 (2).pdf
Private Sector 42 84 0

2011-09-29-04:00

0970-0394 201305-0970-001 0970
             
        "Health Profession Opportunity Grants (HPOG) program"
             
          
        
ACF is implementing a multi-pronged research and evaluation approach for the HPOG program to better understand and assess the activities conducted and their results. The current submission is in support of the HPOG National Implementation Evaluation (NIE) and the HPOG Impact Study. Together, HPOG-NIE and HPOG-Impact will collect data to document and demonstrate how effectively grantees implement the HPOG program and to assess how variations in program services affect program outcomes and impacts. As such, HPOG-NIE and HPOG-Impact will fill a void in the sectoral training and career pathways literature both about program effectiveness and about which types of programs or program components are most effective. 2016-08-31-04:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No Yes No 15929 8212 0

Semi-annual HPOG Program Performance Report No Community and Social Services Social Services Individuals or Households 64 1997 0

Supplemental Baseline Questions (program participants and control group members) No Community and Social Services Social Services Individuals or Households 5250 1313 0

Supplemental Baseline Questions (grantees) No Community and Social Services Social Services Private Sector 5250 1313 0

HPOG-NIE Sampling Questionnaire for the HPOG surveys No Community and Social Services Social Services Private Sector 27 54 0

HPOG-NIE Follow-Up Phone Call Protocol for the Stakeholder/Network survey No Community and Social Services Social Services Private Sector 81 14 0

HPOG-NIE Grantee survey No Community and Social Services Social Services Private Sector 27 108 0

HPOG-Impact Implementation interview guide for partnering employers No Community and Social Services Social Services Private Sector 30 15 0

HPOG-Impact Implementation interview guide for instructors No Community and Social Services Social Services Private Sector 30 23 0

HPOG-Impact Implementation interview guide for HPOG program management No Community and Social Services Social Services Private Sector 10 15 0

HPOG-Impact Implementation interview guide for HPOG program staff No Community and Social Services Social Services Private Sector 40 40 0

HPOG-NIE Management and Staff survey No Community and Social Services Social Services Private Sector 270 135 0

HPOG-NIE Stakeholder/Network survey No Community and Social Services Social Services Private Sector 250 125 0

HPOG-NIE Employer survey No Community and Social Services Social Services Private Sector 100 50 0

HPOG-Impact 15-month Participant Follow-Up survey No Community and Social Services Social Services Individuals or Households 2800 1960 0

HPOG-Impact 15-month Control Group Member Follow-Up survey No Community and Social Services Social Services Individuals or Households 1400 840 0

HPOG-NIE 15-month Participant Follow-Up survey No Community and Social Services Social Services Individuals or Households 300 210 0

2013-08-12-04:00

0970-0395 201107-0970-002 0970
             
        "Evaluation of Tribal Health Profession Opportunity Grants"
             
          
        
The Administration for Children and Families (ACF) is requesting Office of Management and Budget (OMB) approval to collect qualitative data through in-person and telephone interviews and focus groups as part of the evaluation of the Tribal Health Professions Opportunity Grants (HPOG) to develop an understanding of the Program's effectiveness in meeting the tribal health workforce needs. This project provides an opportunity for evaluating the implementation and outcomes of five distinct workforce development approaches that integrate health professional training programs with culturally-informed models of learning and practice. 2014-10-31-04:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 408 485 9632

#1.Grantee and partner administrative staff interview No Community and Social Services Social Services Individuals or Households 35 35 1625

#2.Program implementation staff interview No Community and Social Services Social Services Individuals or Households 117 176 4568

#3.Employer interview No Community and Social Services Social Services Individuals or Households 52 39 1706

#4.Program Participant Focus Group and Interview Protocol No Community and Social Services Social Services Individuals or Households 117 158 1165

#5.Program Completers Interview Protocol No Community and Social Services Social Services Individuals or Households 67 67 494

#6.Program Non-Completers Interview Protocol No Community and Social Services Social Services Individuals or Households 20 10 74

2011-10-19-04:00

0970-0397 201304-0970-001 0970
             
        "Innovative Strategies for Self Sufficiency (ISIS)"
             
          
        
The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing a data collection activity as part of the Innovative Strategies for Increasing Self-Sufficiency (ISIS) demonstration and evaluation. The ISIS evaluation will assess a range of promising post-secondary career pathways programs that promote the improvement of education, employment and self-sufficiency outcomes for economically disadvantaged adults. The major goal of ISIS is to assess the effectiveness of a group of these programs in increasing 1) the receipt of educational credentials, 2) employment and earnings, and 3) self-sufficiency and other measures of well-being. ACF believes that development of rigorous evidence on these matters will be of great use to both policymakers and program administrators. 2016-08-31-04:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 11917 4455 0

#1 - BIF No Community and Social Services Social Services Individuals or Households 2650 663 0

#2 - SAQ No Community and Social Services Social Services Individuals or Households 2650 875 0

#3 - Key Informant Interviews No Community and Social Services Social Services Individuals or Households 0 0 0

New Instrument #1 Basic Information Form Modification No Community and Social Services Social Services Individuals or Households 1882 94 0

New Instrument #2 15 Month Follow-up Survey, no child roster No Community and Social Services Social Services Individuals or Households 2853 2377 0

New Instrument #2 15 Month Follow-up Survey, child roster addition No Community and Social Services Social Services Individuals or Households 521 26 0

New Instrument #2 15 Month Follow-Up Survey, HPOG Questions Addition No Community and Social Services Social Services Individuals or Households 991 82 0

New Instrument #3 Program Leadership/Managers/Supervisors Interview Guide No Community and Social Services Social Services Private Sector 16 32 0

New Instrument #4 Instructional Staff Interview Guide No Community and Social Services Social Services Private Sector 20 40 0

New Instrument #5 Case Managers/Advisor Interview Guide No Community and Social Services Social Services Private Sector 17 34 0

New Instrument #6 Partners Interview Guide No Community and Social Services Social Services Private Sector 18 36 0

New Instrument #7 Case Managers/Advisors Online Survey No Community and Social Services Social Services Private Sector 30 15 0

New Instrument #8 Manager/Supervisor Online Survey No Community and Social Services Social Services Individuals or Households 14 7 0

New Instrument #9 Instructional Staff Online Survey No Community and Social Services Social Services Private Sector 45 23 0

New Instrument #10 Study Participant Interview Guide No Community and Social Services Social Services Individuals or Households 140 140 0

New Instrument #11 Study Participant Check-in Call No Community and Social Services Social Services Individuals or Households 70 11 0

2013-08-19-04:00

0970-0398 201401-0970-001 0970
             
        "Personal Responsibility Education Program (PREP) Multi-Component Evaluation"
             
          
        
The Patient Protection and Affordable Care Act, signed into law in March of 2010, established the Personal Responsibility Education Program (PREP) which funds programs designed to educate adolescents on both abstinence and contraception for the prevention of pregnancy and sexually transmitted infections, including HIV/AIDS, and at least three adulthood preparation subjects. The goal of the PREP Multi-Component Evaluation will be to document how programs funded through the State PREP program are designed and implemented in the field and to assess selected PREP-funded programs' effectiveness. The evaluation has three main components: (1) the Design and Implementation Study; (2) the Performance Analysis Study; and (3) the Impact and In-depth Implementation Study. The PREP program has multiple components. However, this ICR is specifically related to two components of the program - state formula grant funding and "Competitive PREP" discretionary grant funding. 2016-11-30-05:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No Yes No 100340 36931 1124

Design Survey Discussion Guide for use with Researchers, Policy Experts, and Macro-Level Coordinators No Community and Social Services Social Services State, Local, and Tribal Governments 30 30 1124

Discussion Guide for use with Macro-Level Coordinators No Community and Social Services Social Services Individuals or Households 10 10 0

Discussion Guide for Use with Program Directors No Community and Social Services Social Services Individuals or Households 40 80 0

Discussion Guide for Use with Program Staff No Community and Social Services Social Services Individuals or Households 40 80 0

Discussion Guide for Use with School Administrators No Community and Social Services Social Services Private Sector 70 70 0

Participant entry survey No Community and Social Services Social Services Individuals or Households 35103 2925 0

Participant exit survey No Community and Social Services Social Services Individuals or Households 44574 7429 0

Implementation site data collection No Community and Social Services Social Services Private Sector 1400 11200 0

Performance Reporting System Data Entry Form No Community and Social Services Social Services Private Sector 65 1560 0

Sub-awardee data collection and reporting No Community and Social Services Social Services Private Sector 350 6533 0

Baseline Survey No Community and Social Services Social Services Individuals or Households 1900 1425 0

New Instrument #1: Entry Survey (CPREP Participants) No Community and Social Services Social Services Individuals or Households 5891 491 0

New Instrument #2: Exit Survey (CPREP Participants) No Community and Social Services Social Services Individuals or Households 7654 1276 0

New Instrument #3: Performance Reporting System Data Entry Form No Community and Social Services Social Services Private Sector 24 469 0

New Instrument #4: Implementation Site Data Collection Protocol No Community and Social Services Social Services Private Sector 200 1200 0

New Instruments 5, 6, 12: First Follow-Up Surveys No Community and Social Services Social Services Individuals or Households 1600 1200 0

New Instruments 5,6,12: Second Follow-Up Survey No Community and Social Services Social Services Individuals or Households 750 563 0

New Instrument #7: Master List of Topics for Staff Interviews No Community and Social Services Social Services Private Sector 106 107 0

New Instrument #8: Staff Survey No Community and Social Services Social Services Individuals or Households 66 33 0

New Instrument #9: Focus Group Discussion Guide No Community and Social Services Social Services Individuals or Households 107 160 0

New Instrument #10: Program Attendance Data Collection Protocol No Community and Social Services Social Services Private Sector 360 90 0

2014-01-15-05:00

0970-0401 201211-0970-002 0970
             
        "Fast Track Generic Clearance for Collection of Qualitative Feedback on Agency Service Delivery"
             
          
        
This is a generic request to seek feedback from the public on service delivery. This is in accordance with the Administrations's commitment to improving service delivery. 2015-04-30-04:00 Active Robert Sargis 2026907275 No No No 32090 7062 0

NRFC No Community and Social Services Social Services
1 Fatherhood Screener Yes Yes Fillable Fileable Form and instruction Fatherhood Screener - Final.doc
Individuals or Households 90 92 0

NFCM Forms No Community and Social Services Social Services
1 NFCM No No Fillable Printable Form and instruction DraftSurvey_NFCM13_sent to OMB.docx
Individuals or Households 60 3 0

2013 National Child Abuse Prevention Month Special Initiative Survey No Community and Social Services Social Services
1 2013 National Child Abuse Prevention Month Survey Yes Yes Fillable Fileable Form and instruction DraftSurvey_NCAPM13_sent to OMB.docx
Individuals or Households 60 3 0

ANA Services Feedback Survey No Community and Social Services Social Services
1 ANA Services Feedback Survey Yes Yes Fillable Fileable Form and instruction ANA Services Survey-JCM.doc
State, Local, and Tribal Governments 100 50 0

Child Welfare Information Gateway's Customer Satisfaction Assessment No Community and Social Services Social Services
1 Survey Yes Yes Fillable Printable Form and instruction CWIG Customer Satisfaction Assessment_protocols_5.7.13.doc
Individuals or Households 1998 87 0

2013 National Adoption Month Survey No Community and Social Services Social Services
1 2013 National Adoption Month Survey Yes Yes Fillable Fileable Form and instruction NAM Survey_FY14_sent to OMB.docx
State, Local, and Tribal Governments 400 20 0

Customer Satisfaction Survey for CWIG - Revision No Community and Social Services Social Services
1 Survey Yes Yes Fillable Fileable Form and instruction General Customer Survey_rev FY 14_sent to OMB 9 11 13.docx
Individuals or Households 2267 145 0

Native American Grants Conference No Community and Social Services Social Services
1 Survey Yes Yes Fillable Printable Form and instruction Draft Survey for Grantee Input Ver FIANL.pdf
State, Local, and Tribal Governments 60 3 0

2013-01-11-05:00

0970-0402 201307-0970-010 0970
             
        "Mother and Infant Home Visiting Program Evaluation (MIHOPE)"
             
          
        
The Administration for Children and Families, Office of Planning Research and Evaluation (OPRE), and Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) have launched a national evaluation called the Mother and Infant Home Visiting Program Evaluation (MIHOPE). The evaluation was authorized by a provision in the Patient Protection and Affordable Care Act of 2010 (PPACA) (P.L. 111-148), signed by the President on March 23, 2010. Using a mix of research methods, this evaluation will inform the federal government about the effectiveness of the newly established Maternal, Infant and Early Childhood Home-Visiting (MIECHV) program in its first few years of operation, and provide information to help states develop and strengthen home visiting programs in the future. By systematically estimating the effects of home visiting programs across a wide range of outcomes and studying the variation in how programs are implemented, MIHOPE will provide valuable information on the effects of these programs on parents and children. This includes investigating the effects of home visiting on maternal and child well-being, how those effects vary for different home visiting approaches, and how variations in program design and implementation influence program fidelity and impacts. 2016-06-30-04:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No Yes No 34487 11161 0

Telephone contact with state administrators No Community and Social Services Social Services State, Local, and Tribal Governments 49 49 0

First Round Visits with State Administrators No Community and Social Services Social Services State, Local, and Tribal Governments 18 27 0

Second Round Visits with State Administrators No Community and Social Services Social Services State, Local, and Tribal Governments 15 23 0

Visits and Calls with Local Program Directors No Community and Social Services Social Services State, Local, and Tribal Governments 120 360 0

Family Baseline Survey No Community and Social Services Social Services Individuals or Households 1700 1700 0

State Administrator Interview Baseline No Community and Social Services Social Services State, Local, and Tribal Governments 8 16 0

State Administrator Interview 12 Month No Community and Social Services Social Services State, Local, and Tribal Governments 8 16 0

Program Manager Survey_Part 1 Baseline No Community and Social Services Social Services Individuals or Households 29 15 0

Program Manager Survey_Part 2 Baseline No Community and Social Services Social Services Individuals or Households 29 29 0

Program Manager Survey_Part 3 Baseline No Community and Social Services Social Services Individuals or Households 29 29 0

Program Manager Survey 12 Month No Community and Social Services Social Services Individuals or Households 29 58 0

Supervisor Survey Baseline No Community and Social Services Social Services Individuals or Households 23 29 0

Supervisor Survey 12 Month No Community and Social Services Social Services Individuals or Households 23 29 0

Home Visitor Survey Baseline No Community and Social Services Social Services Individuals or Households 160 200 0

Home Visitor Survey 12 Month No Community and Social Services Social Services Individuals or Households 160 200 0

Community Service Provider Survey No Community and Social Services Social Services Individuals or Households 510 51 0

Other Home Visiting Programs Survey No Community and Social Services Social Services Individuals or Households 142 14 0

Supervisor Logs No Community and Social Services Social Services Individuals or Households 1980 396 0

Home Visitor Logs No Community and Social Services Social Services Individuals or Households 10200 2040 0

Program Manager Group Interview 12 Month No Community and Social Services Social Services Individuals or Households 29 44 0

Supervisor Group Interview 12 Month No Community and Social Services Social Services Individuals or Households 33 50 0

Home Visitor Group Interview 12 Month No Community and Social Services Social Services Individuals or Households 57 86 0

Home Visitor Individual Interview 12 Month No Community and Social Services Social Services Individuals or Households 57 86 0

Family Screening and Consent No Community and Social Services Social Services Individuals or Households 1889 189 0

Combined Home Visitor - Supervisor Baseline Survey No Community and Social Services Social Services Individuals or Households 10 18 0

Combined Home Visitor-Supervisor 12 Month Survey No Community and Social Services Social Services Individuals or Households 10 18 0

Home Visitor Logs - Past 15 months No Community and Social Services Social Services Individuals or Households 8500 765 0

Family follow-up survey No Community and Social Services Social Services Individuals or Households 1445 1445 0

Direct parent-child interaction No Community and Social Services Social Services Individuals or Households 2890 1734 0

Direct Child Assessments No Community and Social Services Social Services Individuals or Households 1445 1156 0

Measuring Height and Weight No Community and Social Services Social Services Individuals or Households 2890 289 0

2013-09-03-04:00

0970-0403 201310-0970-004 0970
             
        "Parents and Children Together (PACT) Evaluation"
             
          
        
This information collection request (ICR) is for clearance to collect information for the Parents and Children Together (PACT) evaluation of a subset of Responsible Fatherhood (RF) and Healthy Marriage (HM) grants authorized under the Claims Resolution Act of 2010 (public law 111-291). Work under PACT will be carried out in stages with different types of information collection in each stage. Thus, requests for clearance will be submitted in stages as work progresses. This ICR includes: continued use of previously approved instruments and two new follow-up surveys. One follow-up survey is for use with RF programs selected for the evaluation and the other follow-up survey is for use with HM programs selected for the evaluation. Both surveys will collect data for the impact evaluations. 2016-12-31-05:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 203467 16716 0

Instrument #1: PACT - Discussion Guide No Community and Social Services Social Services Private Sector 50 50 0

Instrument #2a: Introductory Script - Grantee Staff No Community and Social Services Social Services Private Sector 2106 351 0

Instrument #2b: Introductory Script - Program Applicants No Community and Social Services Social Services Individuals or Households 2105 351 0

Instrument #3 - Baseline Survey No Community and Social Services Social Services Individuals or Households 2000 1000 0

Instrument #6 - RF Study MIS No Community and Social Services Social Services Private Sector 75990 2533 0

Instrument 4a: Introductory script - Program Staff Burden No Community and Social Services Social Services Private Sector 2100 351 0

Instrument 4b: Introductory script - HM Program Applicants No Community and Social Services Social Services Individuals or Households 4210 703 0

Instrument 5: Baseline survey - HM Study Participants No Community and Social Services Social Services Individuals or Households 4000 2000 0

Instrument #7: HM Study MIS No Community and Social Services Social Services Private Sector 102000 3400 0

Instrument #8: Semi-structured interview topic guide No Community and Social Services Social Services Private Sector 500 517 0

Instrument #9: On-line Survey for Program Staff No Community and Social Services Social Services Private Sector 500 250 0

Instrument #10: Telephone interviews (with staff at referral organizations) No Community and Social Services Social Services Private Sector 50 25 0

Instrument 11a: On-line Working Alliance Inventory - Program Staff No Community and Social Services Social Services Private Sector 1000 167 0

Instrument 11b: On-line Working Alliance Inventory - Participants No Community and Social Services Social Services Individuals or Households 1000 167 0

Instrument #12: Focus Group Guide No Community and Social Services Social Services Individuals or Households 600 900 0

Instrument #13: Telephone interviews - Program participants (program dropouts) No Community and Social Services Social Services Individuals or Households 150 38 0

Instrument #14: Guide for in-person, in-depth interviews with study participants No Community and Social Services Social Services Individuals or Households 96 192 0

Instrument #15: Check in Call Guide No Community and Social Services Social Services Individuals or Households 128 21 0

Instrument #16: Semi-structured interview topic guide - Hispanic Population Focus No Community and Social Services Social Services Private Sector 42 63 0

Instrument #17: Focus Group Guide - Hispanic Population Focused No Community and Social Services Social Services Individuals or Households 20 30 0

Instrument #18: Questionnaires for Participants in Focus Group with Hispanic Population Focus No Community and Social Services Social Services Individuals or Households 20 7 0

NEW - Instrument #19: RF Follow-up survey - Study Participants No Community and Social Services Social Services Individuals or Households 1600 1200 0

NEW - Instrument #20: HM Follow-up survey - Study Participants No Community and Social Services Social Services Individuals or Households 3200 2400 0

2013-12-09-05:00

0970-0404 201204-0970-002 0970
             
        "Child Welfare Demonstration Projects"
             
          
        
Per section 1130 of the Social Security Act ACF is planning to announce an opportunity for title IV-E agencies to submit proposals for new child welfare waiver demonstration projects for each of FY 2012, 2013 and 3014. These projects allow more flexible uses of Federal funds to test new approaches to service delivery or ninancing structures to improve outcomes for children and families involved in child welfare. 2015-05-31-04:00 Active Robert Sargis 2026907275 No No No 20 450 0

Letter of Intent No Community and Social Services Social Services State, Local, and Tribal Governments 10 50 0

Full Proposal No Community and Social Services Social Services State, Local, and Tribal Governments 10 400 0

2012-05-11-04:00

0970-0406 201209-0970-001 0970
             
        "ACF Performance Progress Report - Program Indicators"
             
          
        
The Office of Grants Managment (OGM), in the Admnistration for Children and Families (ACF) is proposing the collection of program performance data for ACF's discretionary grantees. To collect this data OGM has developed a form from the basic template of the OMB-approved reporting format of the Program Performance Report. OGM will use this data to determine if grantees are proceeding in a satisfactory manner in meeting the approved goals and objectives of the project, and if funding should be continued for another budget period. The requirement for grantees to report on performance is OMB grants policy. Specific citations are contained in: 1) OMB Circular A-102, Grants and Cooperative Agreements with State and Local Governments, also known as the "Common Rule" [codified at 45 CFR Part 92] and 2) OMB Circular A-110, Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Educations, Hospitals, and Other Non-Profit Organizations [codified at 2 CFR Part 215]. 2015-10-31-04:00 Active Robert Sargis 2026907275 No No No 6000 6000 0

ACF-OGM-PPR-B No Community and Social Services Social Services
1 ACF-OGM-PPR-B Yes Yes Fillable Printable Form and instruction Proposed ACF-OGM-PPR Cover Page and Form B Program Indicators and Instructions Part One.pdf
Private Sector 6000 6000 0

2012-10-23-04:00

0970-0407 201203-0970-008 0970
             
        "ORR-2, Quarterly Report on Expenditures and Obligations"
             
          
        
The Refugee Cash and Medical Assistance (CMA) program, implemented by the Office of Refugee Resettlement (ORR) in the Administration for Children and Families (ACF), DHHS, is a reimbursement program for costs incurred by States and non-profit organizations in providing assistance to refugees, asylees, Cuban/Haitian entrants, Amerasians, Afghans and Iraqis with Special Immigrant Visas, and victims of trafficking. The program reimburses States and non-profit organizations for the costs they incur in providing four types of assistance: cash assistance, medical assistance, medical screening, and services for unaccompanied refugee minors. The purpose of the ORR-2 is to collect cost data from grantees for each component of the Program. 2015-08-31-04:00 Active Robert Sargis 2026907275 No No No 232 348 0

ORR-2 No Community and Social Services Social Services
1 ORR-2 Yes Yes Fillable Fileable Form ORR-2 12-11.xlsx
State, Local, and Tribal Governments 232 348 0

2012-08-07-04:00

0970-0408 201305-0970-012 0970
             
        "Permanency Innovations Initiative (PII) Evaluation"
             
          
        
The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), requests permission to collect data for an evaluation of the Permanency Innovations Initiative (PII). This 5-year initiative, funded by the Children's Bureau (CB) within ACF, will build the evidence base for innovative interventions that enhance well-being and improve permanency outcomes for particular groups of children and youth who are at high risk for long-term foster care and who experience the most serious barriers to timely permanency. A major emphasis of the PII is the design of rigorous evaluations that will provide credible evidence and replicable interventions for achieving faster permanency for children and youth in foster care. 2016-08-31-04:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 4155 3071 0

Survey of Organization/System Readiness No Community and Social Services Social Services Private Sector 20 6 0

Implementation Drivers Web Survey No Community and Social Services Social Services Private Sector 288 230 0

Grantee Case Study Protocol No Community and Social Services Social Services Private Sector 100 200 0

Fidelity Data (Implementation Quotient Tracker) No Community and Social Services Social Services Private Sector 16 24 0

Caregiver Initial Information Form No Community and Social Services Social Services Individuals or Households 200 20 0

Family Assessment Battery No Community and Social Services Social Services Individuals or Households 402 603 0

CAFAS/PECFAS No Community and Social Services Social Services State, Local, and Tribal Governments 434 434 0

Caseworker discussions for NCFAS-Gamp;R completion No Community and Social Services Social Services State, Local, and Tribal Governments 420 210 0

Washoe Family Assessment Battery No Community and Social Services Social Services Individuals or Households 304 456 0

DCFS Biological Parent Study Contact Form No Community and Social Services Social Services Private Sector 173 17 0

DCFS Biological Parent Interview No Community and Social Services Social Services Individuals or Households 344 86 0

DCFS Youth and Foster Parent Study Contact Form No Community and Social Services Social Services Private Sector 228 23 0

DCFS Foster Parent Interview No Community and Social Services Social Services Individuals or Households 456 342 0

DCFS Youth Interview No Community and Social Services Social Services Individuals or Households 456 342 0

RISE Staff Pre-Test No Community and Social Services Social Services Individuals or Households 157 39 0

RISE Staff Post-Test No Community and Social Services Social Services Individuals or Households 157 39 0

2013-08-19-04:00

0970-0409 201206-0970-009 0970
             
        "Affordable Care Act Tribal Maternal, Infant, and Early Childhood Home Visiting Guidance"
             
          
        
Section 511(h)(2)(A) of Title V of the Social Security Act, as added by Section 2951 of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148, Affordable Care Act or ACA), authorizes the Secretary of HHS to award grants to Indian Tribes (or a consortium of Indian Tribes), Tribal Organizations, or Urban Indian Organizations to conduct an early childhood home visiting program. The legislation sets aside 3 percent of the total ACA Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program appropriation (authorized in Section 511(j)) for grants to Tribal entities and requires that the Tribal grants, to the greatest extent practicable, be consistent with the requirements of the Maternal, Infant, and Early Childhood Home Visiting Program grants to States and territories (authorized in Section 511(c)), and include (1) Conducting a needs assessment similar to the assessment required for all States under the legislation and (2) establishing quantifiable, measurable 3- and 5-year benchmarks consistent with the legislation. The Administration for Children and Families, Office of Child Care, in collaboration with the Health Resources and Services Administration, Maternal and Child Health Bureau, has awarded grants for the Tribal Maternal, Infant, and Early Childhood Home Visiting Program (Tribal MIECHV). The Tribal MIECHV grant awards support 5-year cooperative agreements to conduct community needs assessments, plan for and implement (in accordance with an Implementation Plan submitted at the end of Year 1) high-quality, culturally-relevant, evidence-based and promising home visiting programs in at-risk Tribal communities, and participate in research and evaluation activities to build the knowledge base on home visiting among Native populations. 2015-09-30-04:00 Active Robert Sargis 2026907275 No Yes No 25 1250 0

Annual Report No Community and Social Services Social Services State, Local, and Tribal Governments 25 1250 0

2012-09-06-04:00

0970-0410 201205-0970-001 0970
             
        "Tribal PREP Implementation Plan and PPR"
             
          
        
The Personal Responsibility Education Program (authorized by P.L. 11-148) requires that grantees funded select an evidence based program model for implementation of the project. In order to assess and evaluate grantee progress throughout the project, information is needed from the grantees in addtion to the PPR Cover Page. This addtional information is primarily requested in the form of performance indicators as they relate to the six standared areas of inquiry/assessment in the PPR. This Tribal PREP PPR is nearly identical to the State PREP PPR, OMB Control No. 0970-0380. 2015-09-30-04:00 Active Robert Sargis 2026907275 No Yes No 48 1760 0

Tribal PREP Implementation Plan No Community and Social Services Social Services State, Local, and Tribal Governments 16 800 0

Tribal PREP PPR No Community and Social Services Social Services
1 PREP PPR Yes Yes Fillable Printable Form Tribal PREP PPR.DOCX
State, Local, and Tribal Governments 32 960 0

2012-09-19-04:00

0970-0412 201207-0970-003 0970
             
        "PMOTOOL"
             
          
        
The purpose of this data collection is to assist the Children's Bureau in using the aggregated data to examine the social impact or public benefit under each federal program. These measurable outcomes will serve as evidence that the federally funded programs are making progress toward achieving broad, legislative program goals. 2015-10-31-04:00 Active Robert Sargis 2026907275 No No No 282 282 0

Abandoned Infants Assistance No Community and Social Services Social Services
1 Abandon Infants Yes Yes Fillable Printable Form and instruction print screen aia.docx
State, Local, and Tribal Governments 40 40 0

Infant Adoption Awareness Program No Community and Social Services Social Services
1 IAATP Yes Yes Fillable Fileable Form and instruction iaatp.docx
State, Local, and Tribal Governments 12 12 0

AO1 No Community and Social Services Social Services
1 AO1 Yes Yes Fillable Fileable Form and instruction ao1.docx
State, Local, and Tribal Governments 90 90 0

Child Abuse and Neglect No Community and Social Services Social Services
1 Child Abuse and Neglect Yes Yes Fillable Fileable Form and instruction can.docx
State, Local, and Tribal Governments 60 60 0

Child Welfare Training No Community and Social Services Social Services
1 CWT Yes Yes Fillable Fileable Form and instruction cwt.docx
State, Local, and Tribal Governments 80 80 0

2012-10-02-04:00

0970-0413 201305-0970-006 0970
             
        "Subsidized and Transitional Employment Demonstration (STED) and Enhanced Transitional Jobs Demonstration (ETJD)"
             
          
        
This request is for a revision to the approved package, to include alternate survey instruments, which were developed for the youth/young adult STED sites. All changes from the original approved package are highlighted throughout the supporting statements. 2016-08-31-04:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 16187 4393 0

Participant Contact Information Form No Community and Social Services Social Services Individuals or Households 1667 133 0

Participant Baseline Information Form No Community and Social Services Social Services Individuals or Households 1667 283 0

Participant STED tracking letters No Community and Social Services Social Services Individuals or Households 3850 193 0

Participant ETJD tracking letters No Community and Social Services Social Services Individuals or Households 3300 165 0

Participant 6-month survey (Adult sites) No Community and Social Services Social Services Individuals or Households 1334 667 0

Participant 12-month survey (Adult sites) No Community and Social Services Social Services Individuals or Households 2667 2000 0

Participant Implementation Questionnaire No Community and Social Services Social Services Individuals or Households 200 34 0

Participant Focus Group Discussion Guide No Community and Social Services Social Services Individuals or Households 80 60 0

Program Staff Implementation Questionnaire No Community and Social Services Social Services Private Sector 40 7 0

Worksite Supervisor Implementation Questionnaire No Community and Social Services Social Services Private Sector 80 14 0

Employer Implementation Questionnaire No Community and Social Services Social Services Private Sector 80 14 0

Program Staff Interview Guides No Community and Social Services Social Services Private Sector 80 80 0

Program Staff Cost Data Collection Protocol No Community and Social Services Social Services Private Sector 4 4 0

Employer Interview Guides No Community and Social Services Social Services Private Sector 16 16 0

Referral Partner Interview Guides No Community and Social Services Social Services Private Sector 16 16 0

Program Staff Time-Use Worksheet No Community and Social Services Social Services Private Sector 40 40 0

Participant 6-month survey (Young Adult sites) No Community and Social Services Social Services Individuals or Households 533 267 0

Participant 12-month survey (Young Adult sites) No Community and Social Services Social Services Individuals or Households 533 400 0

2013-08-06-04:00

0970-0414 201305-0970-010 0970
             
        "Assets for Independence (AFI) Program Evaluation "
             
          
        
The U.S. Department of Health and Human Services, Administration for Children and Families (ACF) is conducting an experimental evaluation of the Assets for Independence (AFI) Program. This evaluation--the first experimental evaluation of IDA projects operating under the Assets for Independence Act--will contribute importantly to understanding the effects of Individual Development Account (IDA) projects and IDA project features on participants. IDA programs provide matching funds to participants when the savings are withdrawn to spend on qualified asset purchases, most commonly homeownership, business-related expenses, or education. This study will build on the prior quasi-experimental AFI evaluation, as well as studies of other non-AFI funded Individual Development Account (IDA) projects. This submission seeks OMB approval for three data collection instruments relating to surveys of the enrolled study sample at baseline (i.e., intake to the programs studied) and 12 months following baseline, and relating to interviews to be conducted with program administrators, staff, and other stakeholders involved in the implementation of the evaluation 2015-10-31-04:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 689 350 0

AFI Baseline Questionnaire: AFI-eligible participants No Community and Social Services Social Services Individuals or Households 367 184 0

AFI Follow-up Questionnaire: AFI-eligible participants No Community and Social Services Social Services Individuals or Households 312 156 0

AFI Implementation Interview Instrument: Administrators and staff No Community and Social Services Social Services Individuals or Households 10 10 0

2013-05-31-04:00

0970-0416 201212-0970-001 0970
             
        "April 2014 Current Population Survey Supplement on Child Support"
             
          
        
The supplement provides data on individuals who are eligible for child support payments, whether such payments are agreed to or awarded, amounts supposed to be a actually received, and whether child support enforcement efforts were instrumental in helping individuals obtain child support. 2015-10-31-04:00 Active Robert Sargis 2026907275 No No No 41300 998 0

April 2014 Current Population Survey Supplement on Child Support No Community and Social Services Social Services
1 Items Booklet Yes Yes Fillable Printable Form and instruction 2014 Items Booklet 6-6-2012.docx
Individuals or Households 41300 998 0

2012-12-13-05:00

0970-0417 201307-0970-007 0970
             
        "45 CFR Part 95, Subpart F--Automatic Data Processing Equipment & Services--Condition for Federal Financial Participation"
             
          
        
The purpose of this request is to obtain an extension to OMB's approval of the reporting and recordkeeping requirements contained in rules at 45 CFR Part 95, Subpart F. These rules pertain to state requests for HHS approval of federal financial participation (FFP) in the costs of ADP systems, equipment and services which support states' administration of HHS' public assistance programs. These include Annual and As-Needed Advance Planning Documents, Request for Proposal (RFP) and contract submissions for prior Federal approval, emergency requests, service agreements and biennial security reports. A final rule making significant changes to the underlying regulation at 45 CFR Part 95 would reduce the information collection burden. The final rule is anticipated to be published in Nov-December 2010 timeframe. 2016-08-31-04:00 Active Robert Sargis 2026907275 No No No 169 5861 0

RFP and Contract No Community and Social Services Social Services State, Local, and Tribal Governments 81 324 0

Advance Planning Document No Community and Social Services Social Services State, Local, and Tribal Governments 41 4896 0

Biennial Reports No Community and Social Services Social Services State, Local, and Tribal Governments 26 39 0

Emergency Funding Requests No Community and Social Services Social Services State, Local, and Tribal Governments 1 2 0

Operational Advance Planning Document No Community and Social Services Social Services State, Local, and Tribal Governments 20 600 0

2013-08-27-04:00

0970-0419 201305-0970-008 0970
             
        "Study of Coordination of Tribal TANF and Child Welfare Services"
             
          
        
The proposed descriptive study will describe and document the ways in which the tribal grantees create and adapt culturally relevant and appropriate approaches, systems, and programs to increase coordination and enhance service delivery to address child abuse and neglect. In addition, the study will document the challenges faced and lessons learned. The information developed through the study will be of value to ACF, the grantees, and a range of stakeholders working with and serving tribal communities, particularly those addressing prevention and reduction of child abuse and neglect. 2016-01-31-05:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 193 158 0

Interview Protocol for Program Staff No Community and Social Services Social Services Private Sector 27 41 0

Interview Protocol for TANF and CW Staff No Community and Social Services Social Services Private Sector 57 57 0

Interview Protocol for Tribal and Community Partners No Community and Social Services Social Services Individuals or Households 27 20 0

Interview Protocol for Tribal Leaders or Elders No Community and Social Services Social Services State, Local, and Tribal Governments 27 27 0

Feedback Form for Community of Learning Events No Community and Social Services Social Services Individuals or Households 50 8 0

Guide to Introductory Call with the Tribal TANF-CW Grantees No Community and Social Services Social Services Private Sector 5 5 0

2013-05-28-04:00

0970-0420 201401-0970-004 0970
             
        "Measurement Development: Family-Provider Relationship Quality (FPRQ)"
             
          
        
The major goal of this project is to develop a measure of the quality of family-provider relationships that will be (1) applicable across multiple types of early care and education settings and diverse program structures (including Early Head Start and Head Start); (2) sensitive across cultures associated with racial, ethnic, and socioeconomic characteristics; (3) reliable in both English and Spanish; and (4) appropriate for program evaluation. As a step in developing this measure, OPRE and OHS request permission to conduct a pilot test and a field test with parents of children aged birth through five years and with early care and education center and home-based providers, teachers, Family Service Workers, and directors. 2015-01-31-05:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 3783 388 0

Director Screener No Community and Social Services Social Services Private Sector 428 34 0

Provider/Teacher Screener No Community and Social Services Social Services Private Sector 758 61 0

Parent Screener No Community and Social Services Social Services Individuals or Households 1650 132 0

Director Survey No Community and Social Services Social Services Private Sector 143 24 0

Provider/Teacher Survey No Community and Social Services Social Services Private Sector 253 43 0

Parent Survey about FSWs No Community and Social Services Social Services Individuals or Households 76 13 0

Parent Survey about Providers/Teachers No Community and Social Services Social Services Individuals or Households 475 81 0

2014-02-06-05:00

0970-0421 201301-0970-004 0970
             
        "Computerized Support Enforcement Systems - Final rule"
             
          
        
The Child Support Enforcement Program was established under title IV-D of the Social Security Act (the Act) by the Social Services Amendments of 1974, for the purpose of enforcing the support obligations owed by absent parents, establishing paternity and obtaining child support. Because States were not providing adequate IV-D services, Congress enacted the Family Support Act of 1988 to strengthen the program by requiring, among other things, mandatory use of support guidelines, immediate income withholding, increased efforts to establish paternity and mandatory automated systems. In addition, the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) further strengthened the program by requiring, among other things, the establishment of State Case and New Hire Registries and an Expanded Federal Parent Locator Service, mandatory implementation of the Uniform Interstate Family Support Act and expedited administrative procedures, and enhanced automated systems. This information collection covers the transmission of both IV-D and non-IV-D data from the State Case Registry to the Federal Case Registry and the additional requirements for States operating under a waiver of Statewideness, and those whose high-risk Information Technology projects have triggered an Independent Validation and Verification review. 2014-06-30-04:00 Active Robert Sargis 2026907275 No No No 4021394 218469 3167264

IV&V ongoing No Community and Social Services Social Services State, Local, and Tribal Governments 24 384 7680

Child Data for IV-D for the SCR: States No Community and Social Services Social Services State, Local, and Tribal Governments 648000 53784 807495

Non IV-D Data for SCR Courts No Community and Social Services Social Services State, Local, and Tribal Governments 1361115 39472 592080

Child Data for Non-IV- D Cases for the SCR: Courts No Community and Social Services Social Services State, Local, and Tribal Governments 648585 53833 807495

Certification of CSE system No Community and Social Services Social Services State, Local, and Tribal Governments 1 240 4800

Case Data Transmitted from SCR to FCR No Community and Social Services Social Services State, Local, and Tribal Governments 2808 7919 3959

Collection of non-IV-D Order Data for the SCR: States No Community and Social Services Social Services State, Local, and Tribal Governments 1360800 62597 938955

IV & V Semi-Annual No Community and Social Services Social Services State, Local, and Tribal Governments 60 160 3200

Waiver Option No Community and Social Services Social Services State, Local, and Tribal Governments 1 80 1600

2013-01-22-05:00

0970-0422 201301-0970-005 0970
             
        "Adoption and Foster Care Analysis and Reporting System (AFCARS), Title IV-B & IV-E"
             
          
        
The existing regulation at 45 CFR 1355.40 sets forth the requirements of section 479 of the Social Security Act for the collection of uniform, reliable information on children who are under the responsibility of the State title IV-B/IV-E agency for placement, care, and adoption. The proposed rule expands upon the existing data collection requirements and institutes new penalties consistent with section 474(f) of the law. Specifically, the data collection system is to provide comprehensive national information on the demographic characteristics of adopted and foster children and their parents; the status of the foster care population; the number and characteristics of children placed in or removed from foster care; children adopted or with respect to whom adoptions have been terminated, and children placed in foster care outside the State which has placement and care responsibility; and the extent and nature of assistance provided by government adoption and foster care programs and the characteristics of the children to whom such assistance is provided. The respondents are the State child welfare agencies, including the District of Columbia and Puerto Rico. The purpose of the data collected is to inform State/Federal policy decisions, program management, respond to Congressional and Departmental inquiries. Specifically, the data is used for short/long-term budget projections, trend analysis, and to target areas for improved technical assistance. The data will provide information about foster care placements, adoptive parents, length of time in care, delays in termination of parental rights and placement for adoption. 2015-02-28-05:00 Active Robert Sargis 2026907275 No No No 144 432720 90150

Adoption and Foster Care Analysis and Reporting System No Community and Social Services Social Services State, Local, and Tribal Governments 144 432720 90150

2013-01-22-05:00

0970-0423 201301-0970-006 0970
             
        "Head Start Grants Administration"
             
          
        
Section 1301 establishes regulations applicable to program administration for all grants under the Head Start Act as amended. 2015-05-31-04:00 Active Robert Sargis 2026907275 No No No 2700 5400 0

Head Start Grants Administration No Community and Social Services Social Services Private Sector 2700 5400 0

2013-01-22-05:00

0970-0424 201301-0970-007 0970
             
        "National Child Abuse and Neglect Data System (NCANDS)"
             
          
        
The National Child Abuse and Neglect Data System meets the requirements of the Child Abuse Prevention and Treatment Act [42 U.S. C. 5101 et seq.] as amended, which requires that States that receive the CAPTA State Child Abuse and Neglect Grant "to annually work with the Secretary to provide, to the maximum extent practicable, a report" that includes the 12 data items listed in the statute. 2015-09-30-04:00 Active Robert Sargis 2026907275 No No No 52 5841 0

Child File, (NCANDS) No Community and Social Services Social Services
1 CF Instruct Yes Yes Paper Only Form Attachment II.1.A_CF Instruct_200907.doc 1 Child File Record Layout Yes Yes Paper Only Form Attachment II.1.B_CF Record Layout_200907.doc
State, Local, and Tribal Governments 0 0 0

Agency file, NCANDS No Community and Social Services Social Services
Yes Yes Paper Only Instruction Attachment II.2.A_AF Instruct_200907.doc 1 AF Record Layout Yes Yes Paper Only Form Attachment II.2.B_AF Record Layout_200907.docx
State, Local, and Tribal Governments 0 0 0

Summary Data Component (SDC), NCANDS No Community and Social Services Social Services
1 SDC Record Layout No No Paper Only Form Attachment II.3.B_SDC Record Layout_200907.doc Yes Yes Paper Only Instruction Attachment II.2.A_AF Instruct_200907.doc
State, Local, and Tribal Governments 0 0 0

National Child Abuse and Neglect Data System No Community and Social Services Social Services State, Local, and Tribal Governments 52 5841 0

2013-01-22-05:00

0970-0425 201301-0970-008 0970
             
        "Application and Program Reporting Requirements for Children's Justice Act Grants"
             
          
        
The Program Instruction for the Children's Justice Act grants, authorized by Title I of the Child Abuse Prevention and Treatment Act (CAPTA), provides direction to States and Territories to accomplish the purposes of assisting States in developing, establishing, and operating programs designed to improve: the handling of child abuse and neglect cases. 2014-06-30-04:00 Active Robert Sargis 2026907275 No No No 52 3120 0

Application and Program Reporting Requirements for Children's Justice Act Grants No Community and Social Services Social Services State, Local, and Tribal Governments 52 3120 0

2013-01-22-05:00

0970-0426 201301-0970-009 0970
             
        "Child & Family Services Plan (CFSP). Annual Progress & Services Report (APSR), & Annual Budget Expenses Request & Estimated Expenditures (CFS-101)"
             
          
        
Under title IV-B, subparts 1 & 2 of the Social Security Act, States/Tribes submit to the Dept a 5 year plan, or its annual update, and an annual budget request and estimated expenditure report. The plan is used by States/Tribes to develop and implement services and describe efforts with other federal, state and local programs. The update reports on activities, accomplishments and adjustments in the plan. The budget request is submitted annually with the plan or its update to apply for appropriated funds for the next fiscal year. 2014-10-31-04:00 Active Robert Sargis 2026907275 No No No 562 29527 0

Child and Family Services Plan No Community and Social Services Social Services State, Local, and Tribal Governments 46 5579 0

Annual Progress and Services Report No Community and Social Services Social Services State, Local, and Tribal Governments 232 17767 0

CFS-101, Parts I, II, and III No Community and Social Services Social Services
1 Part II No No Printable Only Form FY2012 CFS101 Part II R.xls 1 Part III No No Printable Only Form FY2012 CFS101 Part III R.xls 1 Part I No No Printable Only Form FY2012 CFS101 Part I R.xls CFS-101 Annual Budget Expenses Request and Est. Expenditures No No Printable Only Form CFS-101 - 3-17-08.xls No No Printable Only Instruction CFS Part I Iinstructions FY12 02-11.doc No No Printable Only Instruction CFS Part II Instructions FY12 02-11.doc No No Printable Only Instruction CFS Part III Instructions FY12 02-11.doc
State, Local, and Tribal Governments 232 1016 0

Caseworker Visit Data No Community and Social Services Social Services State, Local, and Tribal Governments 52 5165 0

2013-01-22-05:00

0970-0427 201301-0970-010 0970
             
        "Head Start Program Information Report"
             
          
        
The Head Start Act requires that actual population and services data be collected from Head Start and Early Head Start grantees and delegate agencies. PIR is the primary tool for collecting data in the areas of program management, services provided to children, and demographic data about enrolled children and their families. The principle users of the data include local program management, ACF Regional stall, and ACYF Central staff. The data is disseminated widely to other interested parties, including Congress, policy makers at the State level, Training and Tech Assistance providers, and researchers. 2014-12-31-05:00 Active Robert Sargis 2026907275 No No No 24580 12393 0

Head Start Program Information Report No Community and Social Services Social Services
1 2010-2011 Program Information Report Yes Yes Fillable Fileable Form and instruction 2010-2011 Program Information Report.pdf
Private Sector 2690 10760 0

Monthly Enrollment No Community and Social Services Social Services
1 Grantee Entrollment Screenshot from HSES Yes Yes Fillable Fileable Form and instruction HSES Enrollment Reporting Screen.pdf
Private Sector 19200 960 0

Contacts, Locations and Reportable Conditions No Community and Social Services Social Services
1 Contacts Yes Yes Fillable Fileable Form and instruction Contacts page in Edit mode.pdf 1 Reportable Conditions Yes Yes Fillable Fileable Form and instruction Reportable Conditions.pdf 1 Center Location Yes Yes Fillable Fileable Form and instruction Center Locations.pdf
Private Sector 2690 673 0

2013-01-22-05:00

0970-0428 201301-0970-011 0970
             
        "Case Plan Requirement, Title IV-E of the Social Security Act"
             
          
        
Under sections 47(a)(16), 475(5) and 475(6), part IV-E, of the Social Security Act and 45 CFR 1356.2(g), to be eligible for payments States must develop a case plan [as defined in section 475(1) for each child the State receives foster care maintenance payments and provide a case review system that meets the requirements in section 475(5) and 475(6). The case review system assures that each child has a case plan in place designed to achieve placement in a safe, least restrictive (most family-like) setting available. 2015-01-31-05:00 Active Robert Sargis 2026907275 No No No 604453 3022265 43520616

Case Plan Requirement Sections 422, 471 and 475 of te Social Security Act No Community and Social Services Social Services
1 AFCARS Yes Yes Fillable Fileable Form and instruction State Plan Pre-print 1-12-07 Final Highlighted 9-25-07.doc
State, Local, and Tribal Governments 604453 3022265 43520616

2013-01-22-05:00

0970-0430 201309-0970-003 0970
             
        "Child Care and Development Fund Tribal Annual Report"
             
          
        
The Child Care and Development Fund (CCDF) report requests annual tribal aggregate information on services provided through the CCDF, which is required by the CCDF Final Rule (45 CFR parts 98 and 99). Tribal Lead Agencies (TLAs) are required to submit annual aggregate data appropriate to tribal programs on children and families receiving CCDF-funded child care services. The CCDF statute and regulations also require TLAs to submit a supplemental narrative as part of the ACF-700 report. 2016-10-31-04:00 Active Robert Sargis 2026907275 No No No 260 9880 0

Child Care and Development Fund Tribal Annual Report No Community and Social Services Social Services
ACF-700 Aggregate Annual Report Yes Yes Fillable Fileable Form ACF-700 Form (Current).xls
State, Local, and Tribal Governments 260 9880 0

2013-10-23-04:00

0970-0431 201210-0970-005 0970
             
        "Child Welfare Information Gateway Follow-up Survey"
             
          
        
Child Welfare Information Gateway (CWIG) is a service of the Children's Bureau, a component within the Administration for Children and Families, and is dedicated to the mission of connecting professionals and concerned citizens to information on programs, research, legislation, and statistics regarding the safety, permanency, and well-being of children and families. CWIG seeks to continuously identify the needs in the child welfare field, determine the extent to which those needs are being met, and assess the impact of information products and services. The proposed information collection activity includes conducting a follow-up survey with a sample of professional CWIG users. The follow-up survey will gather data about how professionals use Child Welfare Information Gateway's information services in their work and will assess the impact of CWIG products and services. Follow-up survey findings will be applied to make continuous improvements to Child Welfare Information Gateway's website and other information services. 2016-02-29-05:00 Active Robert Sargis 2026907275 No No No 200 34 0

CWIG - Private Sector No Community and Social Services Social Services
1 Survey Yes Yes Fillable Printable Form and instruction Follow-on Survey_10 11 12 final version for OMB.docx
Private Sector 100 17 0

CWIG Follow-up Survey, State, Local, or Tribal Goverments No Community and Social Services Social Services
1 Survey Yes Yes Fillable Printable Form and instruction 1 Survey Yes Yes Fillable Printable Form and instruction Follow-on Survey_10 11 12 final version for OMB_rev 2.4.13.docx
State, Local, and Tribal Governments 100 17 0

2013-02-14-05:00

0970-0432 201303-0970-003 0970
             
        "Appeal Procedures for Head Start Grantees and Current or Prospective Delegate Agencies"
             
          
        
Section 646 of the Head Start Act requires the Secretary to prescribe a timeline for conducting administrative hearings when adverse actions are taken or proposed to be taken against Head Start or Early Head Start grantees and delegate agencies. 2016-02-29-05:00 Active Robert Sargis 2026907275 No No No 20 520 0

Appeal Procedures for Head Start Grantees and Current or Prospective Delegate Agencies No Community and Social Services Social Services Private Sector 20 520 0

2013-03-08-05:00

0970-0433 201303-0970-004 0970
             
        "State Plan for Foster Care and Adoption Assistance:  Title IV-E of the Social Security Act"
             
          
        
A State plan is required by sections 471 and 477(b)(2), part IV-E of the Social Security Act for each public child welfare agency claiming Federal funding for foster care and independent living services and adoption assistance. The State plan is a comprehensive description of the nature and scope of the State's program and provides assurance the program will be administered in conformity with the specific requirements stipulated in title IV-E. 2016-02-29-05:00 Active Robert Sargis 2026907275 No No No 17 272 0

State Plan for Foster Care and Adoption Assistance: Title IV-E of the Social Security Act No Community and Social Services Social Services State, Local, and Tribal Governments 17 272 0

2013-03-08-05:00

0970-0434 201212-0970-004 0970
             
        "Understanding the Dynamics of Disconnection from Employment and Assistance"
             
          
        
The Office of Planning, Research and Evaluation (OPRE) desires to enhance its knowledge about the characteristics, circumstances and well-being of this disconnected population and to develop hypotheses for potential future research. In-depth discussions with disconnected mothers will contribute to improved understanding of specific reasons for their unemployment and lack of assistance, families' coping strategies, and families' perspectives on pathways out of disconnection. 2014-04-30-04:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 675 182 0

Advertisement Script - Los Angeles Site No Community and Social Services Social Services Individuals or Households 300 30 0

Telephone Recruitment Script and Screener - Los Angeles Site No Community and Social Services Social Services Individuals or Households 100 25 0

Follow-up Telephone Script to Schedule Interviews No Community and Social Services Social Services Individuals or Households 36 2 0

Consent Form For Interviews - Los Angeles Site No Community and Social Services Social Services Individuals or Households 36 7 0

Receipt of Payment Form - Los Angeles Site No Community and Social Services Social Services Individuals or Households 36 1 0

Consent Form for Linking Data - Los Angeles Site No Community and Social Services Social Services Individuals or Households 36 3 0

Appendix A-7 - Telephone Recruitment Script and Screener - Michigan Site No Community and Social Services Social Services Individuals or Households 35 9 0

Consent Form for Interviews - Michigan Site No Community and Social Services Social Services Individuals or Households 30 6 0

Conversation Guide No Community and Social Services Social Services Individuals or Households 66 99 0

2013-04-23-04:00

0970-0435 201302-0970-007 0970
             
        "Child Support Document Exchange System (CSDES)"
             
          
        
The Child Support Document Exchange System will provide technical assistance to the states to help them establish effective systems for collecting child and spousal support, facilitate the dissemination of IV-D child and spousal support information to authorized users acting on behalf of a state IV-D child support agency, and help state IV-D agencies in fulfilling the federal requirement to transmit requests for child support case information and provide requested information electronically to the greatest extent possible. 2016-05-31-04:00 Active Robert Sargis 2026907275 No No No 222146 3782 0

On-line Data Entry Screens No Community and Social Services Social Services
1 CSDES Screen Shots Yes Yes Fillable Fileable Form and instruction CSDES Screen Shots_013013.ppt
State, Local, and Tribal Governments 222144 3702 0

Batch Processing No Community and Social Services Social Services
1 CSDES Record Specs Yes Yes Fillable Fileable Form and instruction CSDES_Record Specs_012913.doc
State, Local, and Tribal Governments 2 80 0

2013-05-31-04:00

0970-0436 201304-0970-005 0970
             
        "Descriptive Study of County- versus State- Administered Temporary Assistance for Needy Families (TANF) Programs "
             
          
        
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval for collecting information through semi-structured interviews with key State and county staff on questions of county TANF administration, policies, service delivery and program context, in six states and for collecting information through a telephone interview/web survey from state TANF administrators from other states. Through this information collection, ACF seeks to gain an in-depth, systematic understanding of the differences in program implementation, operations, outputs and outcomes between state and county-administered TANF programs, and identify special technical assistance needs of county-administered programs 2014-08-31-04:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 72 66 0

State TANF administrators discussion guide No Community and Social Services Social Services State, Local, and Tribal Governments 6 6 0

State human service department director discussion guide No Community and Social Services Social Services State, Local, and Tribal Governments 6 6 0

County TANF administrators discussion guide No Community and Social Services Social Services State, Local, and Tribal Governments 12 18 0

County executives discussion guide No Community and Social Services Social Services State, Local, and Tribal Governments 12 12 0

County TANF directors' associations discussion guide No Community and Social Services Social Services State, Local, and Tribal Governments 6 9 0

Telephone interview protocol for state TANF directors No Community and Social Services Social Services State, Local, and Tribal Governments 30 15 0

2013-08-06-04:00

0970-0438 201304-0970-004 0970
             
        "School Readiness Goals and Head Start Program Functioning"
             
          
        
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to conduct a research study with Head Start grantees in order to improve understanding of how local programs define, measure, and communicate school readiness goals, and how they use these goals in program planning to improve program functioning. The study design will include a telephone survey of key personnel at approximately 90 local Head Start and Early Head Start programs, followed by site visits to a subset of 12 of these grantees. 2014-08-31-04:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 485 324 0

Telephone Interview Recruitment Script No Community and Social Services Social Services Private Sector 157 27 0

Telephone Interview No Community and Social Services Social Services Private Sector 90 68 0

Interview Guide for Program Directors and Managers No Community and Social Services Social Services Private Sector 24 36 0

Interview Guide for Other Managers, Coordinators and Specialists No Community and Social Services Social Services Private Sector 60 60 0

Interview Guide with Staff No Community and Social Services Social Services Private Sector 54 54 0

Interview Guide for Governing Body or Policy Council Representatives No Community and Social Services Social Services State, Local, and Tribal Governments 48 36 0

Interview Guide with Local Education Agency Representative No Community and Social Services Social Services State, Local, and Tribal Governments 12 12 0

Interview Guide for Parents No Community and Social Services Social Services Individuals or Households 36 27 0

Interview Guide for AIAN Program Directors No Community and Social Services Social Services Private Sector 4 4 0

2013-08-29-04:00

0970-0439 201304-0970-006 0970
             
        "Child Support Noncustodial Parent Employment Demonstration (CSPED)"
             
          
        
This information collection request (ICR) is for clearance to collect information for the Child Support Noncustodial Parent Employment Demonstration (CSPED) evaluation. Under CSPED, the Office of Child Support Enforcement (OCSE) with the Administration for Children and Families (ACF), Department of Health and Human Services (HHS), has issued grants to eight state child support agencies to provide employment, parenting, and child support services to noncustodial parents who are having difficulty meeting their child support obligations. HHS/ACF/OCSE has issued a grant to the Wisconsin Department of Children and Families to conduct an implementation and cost study and an impact study of CSPED. The evaluation will be based on a randomized controlled trial research design in which program applicants who are eligible for CSPED services will be randomly assigned to either a treatment group that is offered CPSED services or a control group that is not. 2016-09-30-04:00 Active Robert Sargis 2026907275 No No No 116915 8204 0

Staff Interview Topic Guide No Community and Social Services Social Services
1 Staff Interview Topic Guide Yes Yes Fillable Printable Form and instruction IC 1_Staff interview topic guide.docx
Individuals or Households 80 80 0

Focus Group Guide No Community and Social Services Social Services
1 Focus Group Guide Yes Yes Fillable Printable Form IC 2_Focus group protocol_final.docx
Individuals or Households 80 120 0

Program Staff Survey No Community and Social Services Social Services
1 Program Staff Survey Yes Yes Fillable Printable Form and instruction IC 3_Program staff survey.docx
Individuals or Households 133 67 0

Study MIS No Community and Social Services Social Services
1 Study MIS Yes Yes Fillable Printable Form and instruction IC 8_Study MIS to Conduct Random Assignment.pdf
Individuals or Households 100000 3333 0

Introductory Script--Program Staff No Community and Social Services Social Services
1 Introductory Script - Program Staff Yes Yes Fillable Printable Form and instruction IC 5_Introductory Script for Program Staff.docx
Individuals or Households 4200 700 0

Introductory Script--Program Applicants No Community and Social Services Social Services
1 Introductory Script - Program Applicants Yes Yes Fillable Printable Form and instruction IC 6_Introductory Script for Program Participants_final.docx
Individuals or Households 4201 700 0

Baseline Survey No Community and Social Services Social Services
1 Baseline Survey Yes Yes Fillable Printable Form and instruction IC 7 Baseline survey_final.docx
Individuals or Households 4000 2333 0

Study MIS to Conduct Random Assignment No Community and Social Services Social Services
1 Study MIS to Conduct Random Assignment Yes Yes Fillable Printable Form and instruction IC 8_Study MIS to Conduct Random Assignment.pdf
Individuals or Households 4200 700 0

Protocol for Collecting Administrative Records No Community and Social Services Social Services
1 Protocol for Collecting Administrative Records Yes Yes Fillable Printable Form and instruction IC 9_Protocol for collecting administrative records.docx
Individuals or Households 21 171 0

2013-09-12-04:00

0970-0440 201308-0970-002 0970
             
        "Job Search Assistance Strategies (JSA) Evaluation"
             
          
        
The Office of Planning, Research and Evaluation (OPRE) in the Administration for Children and Families (ACF) requests OMB clearance for data collection activities for the Job Search Assistance (JSA) Strategies Evaluation. The JSA Strategies evaluation is a study designed to rigorously test components of job search assistance programs aimed at moving TANF recipients into employment. Despite the widespread prevalence of services to support the search for employment in TANF, known as job search assistance (JSA) services, little is known about the relative effectiveness of different JSA approaches and their components. JSA components that could be studied include self-directed job search, group job search (e.g., job clubs or peer groups), one-on-one search (e.g., individual counseling), and job development (i.e., program staff identify opportunities for clients). With this project, we aim to measure the relative impact of specific job search services offered by TANF programs on short-term labor market outcomes (e.g., earnings and time to employment). 2015-10-31-04:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 51 103 0

Discussion Guide for use with Researchers and Policy Experts No Community and Social Services Social Services Individuals or Households 8 8 0

Discussion Guide for use with State and Local TANF Administrators No Community and Social Services Social Services State, Local, and Tribal Governments 18 45 0

Discussion Guide for use with Program Staff No Community and Social Services Social Services Private Sector 25 50 0

2013-10-31-04:00

0970-0441 201310-0970-003 0970
             
        "Federally Assisted State Transmitted Levy"
             
          
        
The Federally Assisted State Transmitted (FAST) Levy information collection will assist states fulfilling the statutory requirement of securing assets to satisfy support obligations and arrearage by facilitating secure and expeditious transmission of electronic levy notices and repsonses between state child support enforcement agencies and multistate financial institutions. 2016-12-31-05:00 Active Robert Sargis 2026907275 No No No 12 3811 0

Withold Request No Community and Social Services Social Services Private Sector 7 2223 0

Withold Response No Community and Social Services Social Services
1 Fast Levy Record Layout Yes Yes Fillable Printable Form and instruction FAST Levy Record Layout v1.0_092513.docx
State, Local, and Tribal Governments 5 1588 0

2013-12-04-05:00

0970-0442 201310-0970-002 0970
             
        "LIHEAP Grantee Needs Assessment"
             
          
        
This information collection is a direct response to recommendations for strengthening LIHEAP program integrity made by the Government Accountability Office in 2010 and the LIHEAP Program Integrity Work Group, which consisted of a sample of LIHEAP grantees. The purpose of this data collection is to gauge the capacity of LIHEAP grantees to perform two critical tasks. 1. To implement third-party verification of household data obtained during the LIHEAP intake process, in order to strengthen program integrity by reducing the risk of making LIHEAP benefit payments to ineligible households or in the wrong amount. These risks arise in large part when there are errors or fraud in the reporting of household members' identity and income during the LIHEAP intake process. 2014-06-30-04:00 Active Robert Sargis 2026907275 No No No 52 86 0

LIHEAP Grantee Needs Assessment No Community and Social Services Social Services
1 Needs Assessment Yes Yes Fillable Fileable Form and instruction LIHEAP Grantee Capacity Questionnaire 8-21-2013.doc
State, Local, and Tribal Governments 52 86 0

2013-12-18-05:00

0970-0443 201308-0970-001 0970
             
        "Evaluation of the Head Start Designation Renewal System"
             
          
        
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to conduct an evaluation of the Head Start Designation Renewal System (DRS). The purpose of the evaluation is to understand if the Head Start Designation Renewal System is working as intended, as a valid, reliable, and transparent method for identifying high-quality grantees that can receive continuing five-year grants without competition (versus those that are not high-quality and have to compete for renewed funding) and as a system that encourages overall quality improvement. It also seeks to understand the circumstances in which it works more or less well, and the contextual, demographic, and program factors and program actions associated with how well the system is working. 2016-01-31-05:00 Active Steve Hanmer Steven.Hanmer@ACF.hhs.gov 202 401-5651 No No No 860 669 0

Quality Measures Follow Up Interview: Teachers (C) No Community and Social Services Social Services Individuals or Households 280 112 0

Quality Measures Follow Up Interview: Center Directors (D) No Community and Social Services Social Services Private Sector 150 278 0

Quality Measures Follow Up Interview: Program Directors (E) No Community and Social Services Social Services Private Sector 35 39 0

DRS Telephone Interview: Program Directors (F) No Community and Social Services Social Services Private Sector 18 23 0

DRS In-Depth Interview: Agency Directors (G) No Community and Social Services Social Services Private Sector 8 8 0

DRS In-Depth Interview: Program Directors (H) No Community and Social Services Social Services Private Sector 12 12 0

DRS In-Depth Interview: Policy Council/ Governing Body (I) No Community and Social Services Social Services State, Local, and Tribal Governments 38 57 0

DRS In-Depth Interview: Program Managers (J) No Community and Social Services Social Services Private Sector 23 35 0

Competition In-Depth Interview: Agency and Program Directors (K) No Community and Social Services Social Services Private Sector 9 11 0

Competition In-Depth Interview: Policy Council/ Governing Body (L) No Community and Social Services Social Services State, Local, and Tribal Governments 23 35 0

Competition In-Depth Interview: Program Managers (M) No Community and Social Services Social Services Private Sector 14 21 0

Competition Data Capture Sheet (N) No Community and Social Services Social Services Private Sector 250 38 0

2014-01-06-05:00

0985-0005 201205-0985-001 0985
             
        "State Annual Long-Term Care Ombudsman Report"
             
          
        
The State Annual Long Term Care Ombudsman Report is needed to: comply with state and Administration on Aging reporting requirements in the Older Americans Act; carry out recommendations made by the General Accounting Office, the Department of Health and Human Services' Office of the Inspector General, and the Institute of Medicine; advocate at the state and federal levels for changes needed to improve the quality of life and care in long-term care facilities; and effectively manage the Long-Term Care Ombudsman Program at the local, state and federal levels. The report form and instructions have been in continuous use, with minor modifications, since they were first approved by OMB for the FY 1995 reporting period. 2015-07-31-04:00 Active Jason Bennett Jason.Bennett@aoa.hhs.gov 202 357-3408 No No No 52 8569 0

State Annual Long-Term Care Ombudsman Report No Community and Social Services Social Services
0985-0005 National Ombudsman Reporting System Yes Yes Fillable Fileable Form scanned ORT.pdf
State, Local, and Tribal Governments 52 8569 0

2012-07-03-04:00

0985-0006 201211-0985-001 0985
             
        "Performance (Progress) Report for AoA Grantees"
             
          
        
The information submitted by ACL discretionary grantees is used by ACL to: (a) review and monitor the grantee's progress in achieving project objectives; (b) identify significant findings, products, and practices of the project; and (c) identify areas of performance that may benefit from advice and assistance from ACL and, in rare instances, take corrective action. 2015-12-31-05:00 Active Lori Stalbaum 2023573452 No No No 600 12000 0

Performance (Progress) Report for AOA Grantees No Community and Social Services Social Services
1 PPR Instructions Yes Yes Fillable Printable Form and instruction PPR-Instructions_ACL_Aug_2012.doc
State, Local, and Tribal Governments 600 12000 0

2012-12-27-05:00

0985-0007 201205-0985-002 0985
             
        "AoA Title VI Program Peformance Report"
             
          
        
Monitor program operations, growth and results of Title VI funded activities, provide information for responses to inquiries. 2015-07-31-04:00 Active Cynthia LaCounte cynthia.lacounte@aoa.hhs.gov 202 357-0148 No No No 256 640 270

Program Performance Report, Title VI of the Older Americans Act (Grants for Native Americans for Nutritional and Supportive Services) No Community and Social Services Social Services State, Local, and Tribal Governments 256 640 270

2012-07-02-04:00

0985-0008 201305-0985-001 0985
             
        "State Program Report for Titles III and VII of the Older Americans Act"
             
          
        
The Older Americans Act(Section 207(a)(3)instructs the Administration on Aging (AoA) to use, to the maximum extent possible, the data collected by State agencies on aging and other applicable sources of information in the development of performance measures, and in compliance with the Government Performance Results Act of 1993. The State Program Report is the principle means of obtaining this data. This request includes minor revisions to the format previously approved based on State Unit on Aging feedback, program changes, and quarterly ARRA preformance reporting. 2016-07-31-04:00 Active Jason Bennett Jason.Bennett@aoa.hhs.gov 202 357-3408 Yes No No 52 2600 0

State Program Report for Titles III and VII of the Older Americans Act No Community and Social Services Social Services
1 State Program Reporting Yes Yes Fillable Printable Form and instruction UPDATED_SPR_Instrument_for_2013_renewal.pdf
State, Local, and Tribal Governments 52 2600 0

State Program Report for Titles III and VII of the Older Americans Act - Including ARRA funding No Community and Social Services Social Services State, Local, and Tribal Governments 0 0 0

2013-07-02-04:00

0985-0009 201106-0985-001 0985
             
        "Certification of Maintenance of Effort"
             
          
        
The information contained on the Certification of Maintenance of Effort form will be used by the Administration on Aging to verify the amount of state expenditures and make comparisons with the average annual expenditures for the period of three consecutive fiscal years preceeding the given year to assure that a state is in compliance with 45 CFR 1321.49 and 42 USC 3027(a) and 42 USC 3058d. 2014-08-31-04:00 Active Greg Case greg.case@aoa.hhs.gov 202 357-3469 No No No 56 28 0

Certification of Maintenance of Effort No Community and Social Services Social Services
0985-0009 certification of long term care ombudsman expenditures Yes No Printable Only Form Ombudsman_Cert_rev211.doc 0985-0009 Older Americans Act Ombudsman Minimum funding and Non-Supplantation requirements Yes No Printable Only Form Ombudsman_Cert_rev211.doc 0985-0009 Certification of Maintenance Yes No Printable Only Form Certification of MOE exp011.doc
State, Local, and Tribal Governments 56 28 0

2011-08-12-04:00

0985-0022 201309-0985-001 0985
             
        "Alzheimer's Disease Supportive Services Program (ADSSP) Data Collection"
             
          
        
The Alzheimer's Disease Supportive Services Program (ADSSP) was established under Section 398 of the Public Health Service Act (P.L. 78-410; 42 U.S.C. 280c-3). It was amended by the Home Health Care and Alzheimer's Disease Amendments of 1990 (PL 101-557) and by the Health Professions Education Partnerships Act of 1998 (PL 105-392). The ADSSP is administered by the Administration on Aging (AoA) within the U.S. Department of Health and Human Services. The ADSSP program helps states extend supports and services to persons with dementia and their family caregivers, with a focus on underserved populations. The PHS Act requires AoA to "provide for an evaluation of each demonstration project for which a grant is made." In compliance with the PHS Act, AoA developed a new State data collection protocol that will require future ADSSP state grantees (those funded starting in FY 2011) to transmit semi-annual data to AoA. In December 2009, AoA initiated a review of the current ADSSP-Data Reporting Tool (ADSSP-DRT) to ensure the acceptability of these items for evaluating the program and minimizing burden for respondents. This review included experts in the field of Alzheimer's disease and long-term care who are familiar with the program, as well as current ADSSP grantees. Feedback was provided by phone and e-mail over a period of 4 months. The result of this input is the revised ADSSP-DRT and supporting documents. As with the current ADSSP-DRT, AoA will work with ADSSP grantees to ensure easy access to a reporting system and offer regular training in using the tool to ensure minimal burden for program grantees. 2016-12-31-05:00 Active Jason Bennett Jason.Bennett@aoa.hhs.gov 202 357-3408 No No No 94 1410 0

Alzheimer's Disease Supportive Services Program (ADSSP) Data Collection No Community and Social Services Social Services State, Local, and Tribal Governments 94 1410 0

2013-12-02-05:00

0985-0024 201211-0985-002 0985
             
        "Performance Data Collection for SMP Program Outcome "
             
          
        
This data collection is required by Congress for program monitoring and Government Performance Results Act (GPRA) purposes. This is the only data collection requested of the SMP Programs which is used by Congress and the media for reporting SMP activities. There are 54 programs in all 50 states, including the District of Columbia, Puerto Rico, Guam and the U.S. Virgin Islands. It is imperative that data be collected to ensure that volunteers' contacts are giving Medicare beneficiaries the tools to prevent, detect and report health care fraud, error and abuse. The respondents are grantees and volunteers who meet with Medicare beneficiaries in group settings and in one-on-one sessions to educate them on the importance of being aware of fraud, error and abuse, and having the knowledge to protect the Medicare system. 2016-02-29-05:00 Active Jason Bennett Jason.Bennett@aoa.hhs.gov 202 357-3408 No No No 54 7452 0

Performance Data Collection for SMP Program Outcome Revised No Community and Social Services Social Services
1 SMP Outcome Form No No Fillable Printable Form OIGSMPTemplate.docx
State, Local, and Tribal Governments 54 7452 0

2013-02-07-05:00

0985-0026 201208-0985-001 0985
             
        "Financial Status Reporting Form for Program of State Council on Developmental Disabilities"
             
          
        
For the program of the State Council on Developmental Disabilities, funds are awarded to Stage Agencies contigent on fiscal requirements in Subtitle B of the Developmental Disabilities Assistance and Bill of Rights Act. 2015-11-30-05:00 Active Jason Bennett Jason.Bennett@aoa.hhs.gov 202 357-3408 No No No 165 842 0

Financial Status Reporting Form for Program of State Council on Developmental Disabilities No Community and Social Services Social Services
0985-0026 Financial Status Report State Councils on Dev. Disabilities No No Fillable Printable Form and instruction SCDD-ADD02B-08-Inst.docm
State, Local, and Tribal Governments 165 842 0

2012-11-07-05:00

0985-0027 201205-0985-004 0985
             
        "Developmental Disabilities Protection and Advocacy Program Performance Report"
             
          
        
Required by federal statute. Each State Protection and Advocacy System must prepare and submit a Program Performance Report for the preceding fiscal year of activities and accomplishments and of conditions in the State. 2014-06-30-04:00 Active Robert Sargis 2026907275 No No No 57 2508 0

Developmental Disabilities Protection and Advocacy Program Performance Report No Community and Social Services Social Services
1 PADD PPR No No Paper Only Form and instruction PAPPR08-C-Inst-v1.rtf
State, Local, and Tribal Governments 57 2508 0

2012-05-25-04:00

0985-0028 201205-0985-005 0985
             
        "Protection and Advocacy Voting Access Annual Report"
             
          
        
An application and annual report is required by Federal Statute (the Help America Vote Act (HAVA) of 2002, Public Law 107-252, Section 291, Payments for Protection and Advocacy Systems, 42.U.S.C. 15461). Each state Protection and Advocacy System that receives funding is required to prepare and submit an annual report at the end of every fiscal year. The report addresses the activities conducted with the funds provided during the year. The information collected from the annual report will be aggregated into an annual profile of how HAVA funds have been spent. The report will also provide an overview of the P&A goals and accomplishments and permit the Administration on Developmental Disabilities to track progress to monitor grant activities. 2015-05-31-04:00 Active Robert Sargis 2026907275 No No No 55 1100 0

Application No Community and Social Services Social Services State, Local, and Tribal Governments 55 1100 0

2012-05-25-04:00

0985-0029 201205-0985-006 0985
             
        "Developmental Disabilities State Plan"
             
          
        
A plan developed by the State Council on Developmental Disabilities is required by federal statute. Each State Council on Developmental Disabilities must develop the plan, provide for public comments in the State, provide for approval by the State's Governor, and finally submit the plan on a five year basis. This insturment provides the basis for meeting this statutory requirement. 2014-08-31-04:00 Active Robert Sargis 2026907275 No No No 55 20185 0

Developmental Disabilities State Plan No Community and Social Services Social Services
1 State Councils OLDC Form Yes Yes Paper Only Form and instruction SCDD-StPlan-08-Instr.doc
State, Local, and Tribal Governments 55 20185 0

2012-05-25-04:00

0985-0030 201306-0985-001 0985
             
        "Annual Report on Progress - University Centers for Excellence in Developmental Disabilities Education, Research, and Service"
             
          
        
Section 104 (42 USC 15004) of the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (DD Act of 2000) directs the Secretary of Health and Human Services to develop and implement a system of program accountability to monitor the grantees funded under the DD Act of 2000. The program accountability system shall include the National Network of University Centers for Excellence in Developmental Disabilites Education, Research, and Service (UCEDDs) authorized under Part D of the DD Act of 2000. 2016-09-30-04:00 Active Jason Bennett Jason.Bennett@aoa.hhs.gov 202 357-3408 No No No 67 94604 0

Annual Report on Progress - University Centers for Excellence in Developmental Disabilities Education, Research, and Service No Community and Social Services Homeownership Promotion
1 UCEDD Yes Yes Fillable Printable Form and instruction UCEDD_PPR_Template_FinalDraft.docx
Federal Government 67 94604 0

2013-09-26-04:00

0985-0032 201205-0985-009 0985
             
        "Help America Vote Act (HAVA) Voting Access Annual Report and Application-States"
             
          
        
An annual report is required by Federal Statute (the Help America Vote Act (HAVA) of 2002, Public Law 107-252, Section 261, Payments to States and Local Units of Government, 42.U.S.C. 15421). Each State or Unit of Local Government that receives funding must prepare and submit an annual report at the end of every fiscal year. The report addresses the activities conducted with the funds provided during the year. The information collected from the annual report will be aggregated into an annual profile of how States have utilized the funds and establish best practices for election officials. It will also provide an overview of the State election goals and accomplishments and permit the Administration on Developmental Disabilities to track progress of voting accessibility to monitor grant activities. 2014-08-31-04:00 Active Robert Sargis 2026907275 No No No 110 4070 6050

HAVA Application - States No Community and Social Services Social Services State, Local, and Tribal Governments 55 1320 1925

HAVA Annual Report - States No Community and Social Services Social Services State, Local, and Tribal Governments 55 2750 4125

2012-05-25-04:00

0985-0033 201208-0985-002 0985
             
        "Developmental Disabilities Council Program Performance Report"
             
          
        
A Developmental Disabilities Council Program Performance Report is required by federal statute. Each State Developmental Disabilities Council must submit an annual report for the preceding fiscal year of activities and accomplishments. Information provided in the Program Performance Report will be used (1) in the preparation of the Annual Report to the President, the Congress and the National Council on Disabilities and (2) to provide a national perspective on a program accomplishments and continuing challenges. 2015-08-31-04:00 Active Robert Sargis 2026907275 No No No 56 7728 0

Developmental Disabilities Council Program Performance Report No Community and Social Services Social Services
1 SCDD Performance Report Yes Yes Fillable Printable Form and instruction COUNCIL_PPR_TEMPLATE_DRAFT_APR_2012.docx
State, Local, and Tribal Governments 56 7728 0

2012-08-13-04:00

0985-0034 201210-0985-001 0985
             
        "Developmental Disabilities Protection and Advocacy Statement of Goals and Priorities"
             
          
        
Required by federal statute and regulation. Each State Protection and Advocacy System must prepare and submit to public comment a Statement of Goals and Priorities (SGPs). The final version of this SGP, following the required public input for the coming fiscal year is submitted to ADD. The information in the SGP will be aggregated into a national prospective profile of where Protection and Advocacy Systems are going. It will provide ADD with a tool for monitoring of the public input requirement. 2015-11-30-05:00 Active Jason Bennett Jason.Bennett@aoa.hhs.gov 202 357-3408 No No No 57 2508 0

Developmental Disabilities Protection and Advocacy Statement of Goals and Priorities No Community and Social Services Social Services
PADD PA-SGP06instrv2 No No Fillable Printable Form PA-SGP06-C-Inst-v1[1].docx
State, Local, and Tribal Governments 57 2508 0

2012-11-07-05:00

0985-0035 201208-0985-003 0985
             
        "Evaluation of the Aging Disability Resource Center Program"
             
          
        
This study will help determine whether Aging and Disability Resource Centers (ADRCs)are meeting the Long Term Service and Support needs of the aging and disability populations. The Administration for Community Living (ACL) will gather information about whether ADRCs, as compared to other systems, are more personalized, consumer-friendly, streamlined, and efficient. ACL is also interested in determining whether consumers who access ADRCs, as compared to consumers who access other systems, report being more empowered to make informed decisions about their care options, are better able to plan ahead for their future long-term care needs, and have more understanding of, and access to, long term services and supports. The evaluation will analyze the relationship between the range and mix of services received by ADRC consumers with their satisfaction with services, perceptions of their own quality of life and the extent of which those services helped them to remain in the community (rather than enter a residential facility such as a nursing home.)Staff of the Administration on Aging's Office of Nutrition and Health Promotion Programs will use the information and recommendations resulting from the evaluation of the Aging and Disability Resource Centers to both determine the value of the ADRC model and to improve program operations. Data will be collected from State-level and local-level ADRCs and Area Agencies on Aging (AAAs) as well as from a sample of consumers who contact a participating ADRCs or AAAs during the study enrollment period. 2016-01-31-05:00 Active Jason Bennett Jason.Bennett@aoa.hhs.gov 202 357-3408 No No No 9562 2060 0

Evaluation of the Aging and Disability Resource Center Program No Community and Social Services Social Services
0985-NEW Final ADRC Evaluation No No Fillable Printable Form and instruction FINAL ADRC Evaluation Data Collection Instruments for 30-day notice 5-14-12.pdf
Private Sector 9562 2060 0

2013-01-14-05:00

0985-0036 201303-0985-001 0985
             
        "Chronic Disease Self-Management Education Program "
             
          
        
The Administration on Aging (AoA), now part of the Administration for Community Living, will use this set of data collection tools to monitor 22 grantees that were awarded cooperative agreements in response to the "PPHF 2012 Empowering Older Adults and Adults with Disabilities through Chronic Disease Self-Management Education (CDSME) Programs financed by 2012 Prevention and Public Health Funds (PPHF-2012) funding opportunity. The PPHF is accompanied by a high level of transparency, oversight, and accountability. All recipients of PPHF must follow Health and Human Services guidance related to the tracking, monitoring and reporting on the use of PPHF financing. AoA has outlined basic requirements for reporting in the CDSME Program Announcement and in the Standard Terms and Conditions of grantees' notice of awards. These notices require each grantee to prepare and submit progress reports to AoA that will enable the agency to monitor program performance. AoA will use the information to: 1) comply with reporting requirements required by the authorizing statutes, 2) collect data for performance measures used in the justification of the budget to Congress and by program, state and national decision makers, 3) effectively manage the CDSME program at the federal, state, and local levels, 4) identify program implementation issues and technical assistance needs, 5) identify best practices to serve as the basis for developing resources to help grantees learn from and replicate these practices, and 6) to provide information for reports to Congress, other government agencies, stakeholders and to the public about grantee progress. Data will be collected from State-level public health or state unit on aging government staff, local community agency staff and volunteers involved in delivering CDSME workshops, as well as individuals who participate in CDSME workshops. 2016-07-31-04:00 Active Jason Bennett Jason.Bennett@aoa.hhs.gov 202 357-3408 No Yes No 28122 3990 0

Chronic Disease Self-Management Education Program No Community and Social Services Social Services
1 Workshop InfoCover Sheet Yes Yes Fillable Fileable Form and instruction Attachment L Workshop Info Cover Sheet.pdf 3 Attendance Log Yes Yes Fillable Fileable Form and instruction Attachment N Attendance Log.pdf 2 Participant Information Survey Yes Yes Fillable Fileable Form and instruction Attachment M Participant Information Survey.pdf 4 Organization Site Types Yes Yes Fillable Fileable Form and instruction Attach_P_Organization_Site_Types_508.pdf
Private Sector 28056 3550 0

Chronic Disease Self-Management Education Program No Community and Social Services Social Services
6 CDSME Sustainability Tool Yes Yes Fillable Fileable Form and instruction Attach Q CDSME Sustainability Tool 2-28-2013.pdf 5 Semi-annual Performance Report and sample template Yes Yes Fillable Fileable Form and instruction Attachment O Semi-Annual Performance Report Directions and Sample Template.pdf
State, Local, and Tribal Governments 66 440 0

2013-07-02-04:00

0985-0037 201305-0985-002 0985
             
        "OAA Title III-C Evaluation of the Elderly Nutrition Services Program"
             
          
        
The Administration on Aging (AoA) through the Older Americans Act(OAA)programs provide a comprehensive and coordinated system of home-and community-based services to assist older adults stay in their community. The OAA Title III-C Elderly Nutrition Services Program(ENSP) is part of these comprehensive home-and community-based services. It is intended to reduce hunger and food insecurity, reduce social isolation and improve the health and well-being of the older adult who participate. The Older Americans Act requires AoA to conduct evaluations of OAA programs. Specifically, their effectiveness in achieving stated goals, and in relation to their cost, their impact on related programs, their effectiveness in targeting services to vulnerable older individuals, and their structure and mechanisms for delivery of services, including, comparisons with appropriate control groups composed of persons who have not participated in such programs. The purpose of this data collection is to fulfill this requirement and understand how well this program is meeting its goals and mission through the conduct of a process and outcome evaluation that is a rigorous and independent assessment of the Program's progress, efficiency and effectiveness. This information collection will be used by AoA to measure how well and under what circumstances the ENSP meets its legislative intent and goals. The evaluation design is comprised of three primary components, but this data collection request is only for the Process evaluation and cost study: 1. A process study, which examines the strategies, activities, and resources of the program at each level of the Aging Network - State Unit on Aging (SUA), Area Agency on Aging (AAA), and Local Service Provider (LSP); 2. A cost study, which determines the cost per meal by cost category and program type at the local level; and 3. A client outcome study, which examines the health and social effects of the program on participants compared to non-participants. Included is an analysis of the nutrient quality of the meals provided. 2016-12-31-05:00 Active Jason Bennett Jason.Bennett@aoa.hhs.gov 202 357-3408 No No No 956 1466 0

OAA Title III-C Elderly Nutrition Services Program Evaluation No Community and Social Services Social Services
1 ENSP Evaluation Yes Yes Fillable Printable Form and instruction ENSP_Eval_DataCollection_PartB_AppendixC.pdf
Private Sector 900 1372 0

OAA Title III-C Elderly Nutrition Services Program Evaluation - SUA No Community and Social Services Social Services
1 ENSP Evaluation State Unit on Aging collection Yes Yes Fillable Printable Form and instruction ENSP_Eval_DataCollection_PartB_AppendixC.pdf
State, Local, and Tribal Governments 56 94 0

2013-12-18-05:00

0990-0001 201309-0990-001 0990
             
        "Application of Waiver of the 2 Year Foreign Residence Requirement of the Exchange Visitor Program"
             
          
        
The information requred by use of this form and supplementary information sheets is used by this Department to make a determination, in accordance with its published regulations, as to whether or not to request from the Department of State, a waiver of the two-year foreign residence requirement for applicants in the United States on a J-1 visa. 2016-12-31-05:00 Active Sherrette Funn-Coleman 2026905683 No No No 80 800 100000

Application waiver Supplemental A Research No Health Health Care Services
No No Paper Only Other 0990-0001waiver application.doc 426 Application No No Paper Only Form 0990-0001_waiver-supplementary_A info.doc
Private Sector 45 450 56250

Apllication Waiver/ Supplemental B Clinical Care No Health Health Care Services
426 Application No No Paper Only Form 0990-0001_waiver-supplementary_A info.doc 426 Application No No Paper Only Form 0990-0001waiver application.doc
Private Sector 35 350 43750

2013-12-02-05:00

0990-0162 201010-0990-003 0990
             
        "State Medicaid Fraud Control Units Annual Report and Recertification Application"
             
          
        
The information contained in the annual reports and recertification application requests is required for the yearly certification/recertification of the current 49 state Medicaid Fraud Control Units by the Office of Inspector General (OIG). The information collected is reviewed and evaluated by the OIG to insure that federal matching grant funds to the Units are only expended for allowable costs incurred by the Units. The OIG also uses the information to determine if a particular state unit or units' needs technical assistance. 2014-02-28-05:00 Active Sherrette Funn-Coleman 2026905683 No No No 100 4650 0

State Medicaid Fraud Control Units Annual Report and Recertification Application No Law Enforcement Criminal Investigation and Surveillance State, Local, and Tribal Governments 50 4400 0

Certification/Recertification Application No Law Enforcement Criminal Investigation and Surveillance State, Local, and Tribal Governments 50 250 0

2011-01-06-05:00

0990-0221 201308-0990-001 0990
             
        "Family Planning Annual Report:  Forms and Instructions"
             
          
        
This annual reporting requirement is for family planning service delivery projects authorized and funded under the Population Research and Voluntary Family Planning Programs (Section 1001 Title X of the Public Health Service Act, 42 USC 300). The FPAR is the only source of annual, uniform reporting by all Title X family planning service grantees. OPA uses FPAR data to monitor compliance with statutory requirements, to comply with accountability and performance requirements of GPRA and HHS plans, and to guide program planning and evaluation. 2016-09-30-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 93 3348 205251

Family Planning Annual Report: Forms and Instructions No Health Health Care Services State, Local, and Tribal Governments 93 3348 205251

2013-09-16-04:00

0990-0260 201203-0990-003 0990
             
        "Protection of Human Subjects:  Common Rule (56 FR 28003)"
             
          
        
The Common Rule (56 FR 27003) establishes Federal policy for the protection of human subjects of Federally conducted or sponsored research. The common rule, published in 1991, requires applicant and awardee institutions to establish procedures to report, disclose and maintain required informaiton including informed consent and assurance of the establishment of an Institutional Review Board. 2015-04-30-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 328980 1138230 0

103(b)(4), .109(d)IRB Actions, .116 and .117 Informed Consent No Health Health Care Services Private Sector 235980 235980 0

.115(a) IRB Recordkeeping No Health Health Care Services Private Sector 90000 900000 0

103(b)(5) Incident Reporting, .113 Suspension or Termination Reporting No Health Health Care Services Private Sector 3000 2250 0

2012-04-27-04:00

0990-0263 201201-0990-006 0990
             
        "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption"
             
          
        
The purpose of this Form is to provide a simplified procedure for institutions engaged in research conducted or supported by the Department of Health and Human Services (HHS) to satisfy the requirements of HHS regulations for the protection of human subjects at 45 CFR 46.103. The respondents for this collection are institutions engaged in research involving human subjects where the research is supported by HHS. Institutional use of the form is also relied upon by other federal departments and agencies that have codified or follow the Federal Policy for the Protection of Human Subjects (Common Rule) which is identical to 45 CFR part 46, subpart A. 2015-03-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 24000 12000 0

Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption No Health Public Health Monitoring Federal Government 24000 12000 0

2012-03-28-04:00

0990-0275 201307-0990-007 0990
             
        "Implementation of an Internet & Paper-Based Uniform Data Set for OMH-funded Activities"
             
          
        
Involves transitioning the developed paper-based UDS modules to the Web-based prototype and will be implemented among OMH-partners. Will be regular system for reporting program management and performance data for all OMH-funded activities. 2016-08-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 400 600 0

OMH Grantee No Health Health Care Services State, Local, and Tribal Governments 400 600 0

2013-08-01-04:00

0990-0278 201105-0990-001 0990
             
        "Federalwide Assurance (FWA)"
             
          
        
The FWA is designed to provide a simplified procedure for institutions engaged in HHS-conducted or supported research to satisfy the assurance requirements of Section 491(a) of the Public Health Service Act and of HHS regulations for the protection of human subjects at 45 CFR 46.103. The respondents are institutions engaged in human subjects research conducted or supported by HHS. 2014-06-30-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 22000 11000 0

Federalwide Assurance (FWA) No Health Public Health Monitoring
0990-0278 FWA Yes Yes Fillable Fileable Form and instruction 0990-0278-Proposed FWA Form-For both US and non-US institutions_PRA _31 March 2011.doc Yes Yes Fillable Fileable Instruction 0990-0278-Proposed Instructions for the Federalwide Assurance PRA to Toni_31 March 2011.doc Yes Yes Fillable Fileable Instruction 0990-0278-Proposed Terms of the Federalwide Assurance PRA _ 31 March 2011.docx
Federal Government 22000 11000 0

2011-06-02-04:00

0990-0279 201206-0990-005 0990
             
        "Institutional Review Board/Independent Ethics Committee Registration Form"
             
          
        
The respondents for this collection are institutions or organizations operating IRBs designated by an institution under an assurance of compliance approved for federalwide use by OHRP under 45 CFR 46.103(a) and that review human subjects research conducted or supported by HHS, or, in the case of FDA's regulation, each IRB in the United States that reviews clinical investigations regulated by FDA under sections 505(i) or 520(g) of the Federal Food, Drug and Cosmetic Act; and each IRB in the United States that reviews clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products. 2015-08-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 14000 14000 0

Institutional Review Board/Independent Ethics Committee Registration Form No General Government Legislative Functions State, Local, and Tribal Governments 12200 12200 0

FDA-IRA No General Government Legislative Functions Private Sector 1800 1800 0

2012-08-15-04:00

0990-0281 201209-0990-001 0990
             
        "Prevention Communication Formative Research"
             
          
        
This generic clearance request describes data collection activities involving a limited set of focus groups, individual interviews, Web-based concept and prototype testing, and usability and effects testing to establish a deeper understanding of the interests and needs of consumers and health intermediaries for disease prevention and health promotion information and tools. 2015-11-30-05:00 Active Sherrette Funn-Coleman 2026905683 No No No 4647 1643 0 2012-11-26-05:00

0990-0302 201211-0990-001 0990
             
        "Medical Reserve Corps (MRC) Unit Profile and Reports"
             
          
        
The OCVMRC uses MRC unit data in reports and presentations, and analyzes the data to assess the maturation of the program, confirm that MRC units are carrying out activities in support of the Surgeon General priorities, and to best tailor the technical assistance provided to MRC units. In addition, the data serves as an important recruitment tool for the individual MRC units. Often, before committing to volunteer with an MRC unit, potential volunteers go to the MRC website (www.medicalreservecorps.gov) to review the local MRC profile, which includes its name and point of contact, the most recent MRC unit activities, the community served, the date established, a narrative profile, and an up-to-date count of its volunteers. 2015-12-31-05:00 Active Sherrette Funn-Coleman 2026905683 No No No 4818 4818 0

Medical Reserve Corps (MRC) Unit Profile and Reports No Health Health Care Services State, Local, and Tribal Governments 4818 4818 0

2012-12-28-05:00

0990-0308 201306-0990-003 0990
             
        "The Effect of Reducing Falls on Acute and Long -Term Care Expenses"
             
          
        
ASPE is continuing a demonstration and evaluation of a multi-factorial fall prevention program to measure its impact on health outcomes for the elderly as well as acute and long-term care use and cost. This is accomplished by obtaining a sample of individualts with private long term care insurance who are age 75 and over. ASPE employs a multitiered random experimental research design to evaluate the effectiveness of the proposed fall prevention intervention program. 2016-08-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 5379 1862 0

Initial Telephone Screen No Health Illness Prevention Federal Government 835 278 0

In person Interview No Health Illness Prevention Individuals or Households 435 544 0

Jump Start phone call No Health Illness Prevention Individuals or Households 435 218 0

Quarterly telephone calls No Health Illness Prevention Individuals or Households 3340 557 0

Telephone screen No Health Illness Prevention Individuals or Households 0 0 0

In person interview-Field Test No Health Illness Prevention Individuals or Households 0 0 0

Intial telephone screen No Health Illness Prevention Individuals or Households 0 0 0

Quarterly phone call No Health Illness Prevention Individuals or Households 0 0 0

Final telephone screen No Health Illness Prevention Individuals or Households 167 56 0

Final In person interview No Health Illness Prevention Individuals or Households 167 209 0

2013-08-12-04:00

0990-0317 201311-0990-001 0990
             
        "HHS Supplemental Form to the SF-424 (HHS 5161-1)"
             
          
        
The Office of the Secretary (OS)at the U.S. Department of Health and Human Services(HHS), on behalf of the former Public Health Service (PHS) agencies, is requesting a 3-year extension with change (revision) of the HHS 5161-1 form. During this 3 year clearance HHS will conduct a Departmental wide evaluation to decide if HHS will continue to use this form and if so, allow the users of the form to make changes that will be make the form more efficient for future use. 2017-01-31-05:00 Active Sherrette Funn-Coleman 2026905683 No No No 7457 19930 0

HHS 5161-1 No Health Public Health Monitoring
5161 Checklist_Narrative Yes Yes Fillable Printable Form 0990-0317_5161-SS-A_B.pdf
State, Local, and Tribal Governments 7457 19930 0

2014-01-22-05:00

0990-0322 201107-0990-001 0990
             
        "Safe Harbor for Federally Qualified Health Centers Arrangements"
             
          
        
We have developed this Safe Harbor regulation in accordance with Congress's direction at section 431 of MMA. Section 431 of MMA amended the anti-kickback statue to create a new safe harbor for certain agreements involving health centers. 2014-12-31-05:00 Active Sherrette Funn-Coleman 2026905683 No No No 1873 1873 0

Health Center (administrative professional) No Health Health Care Services Private Sector 1873 1873 0

2011-12-12-05:00

0990-0323 201312-0990-002 0990
             
        "Medical Countermeasures.Gov"
             
          
        
During the BioShield Stakeholders Workshop, HHS Secretary Michael O. Leavitt announced that HHS would develop a stakeholders' portal, which would be a "web-based system through which those in industry and the research and development community can reach the people they need in the federal government, whether they're looking at a basic level of research or focused on end-stage development." Which led to developing Medical Countermeasures.gov to facilitate communication between federal government agencies and public stakeholders to enhance the Nation's public health emergency preparedness. 2017-01-31-05:00 Active Sherrette Funn-Coleman 2026905683 No No No 225 30 0

Developers of Medical Countermeasures to naturally occuring and intentional public health threats No General Government Legislative Functions State, Local, and Tribal Governments 225 30 0

2014-01-02-05:00

0990-0330 201110-0990-001 0990
             
        "OMHA Annual Appellant Climate Survey"
             
          
        
The Office of Medicare Hearings and Appeals (OMHA)requests a three year programmatic clearance from the OMB to conduct customer research through external surveys by means of telephone interviews and web-based suveys. The proposed information collection request covers all types of OMHA appellants, with a primary focus on the three appellant types who receive benefits from OMHA-beneficiares, providers, and suppliers. 2014-12-31-05:00 Active Sherrette Funn-Coleman 2026905683 No No No 400 73 0

Health Care Providers and Suppliers No General Government Executive Functions Individuals or Households 120 22 0

Beneficiaries No General Government Executive Functions Individuals or Households 280 51 0

2011-12-30-05:00

0990-0331 201111-0990-003 0990
             
        "Evaluation of The Marriage and Family Strengthening Grants"
             
          
        
The Office of Family Assistance within the Administration for Children and Families ACF is conducting a dmeonstration program called Marriage and Family stregthening Grants for Incarerated and Re-entering Fathers and their partners (MFS-IP). These demonstration programs are funded to support activities in the areas of marriage strengthening and responsible fatherhood among incarcerated and recently released fathers, their partners, and children. 2015-08-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 1736 2606 0

MFS-IP Follow-up Survey-(9/18 month)Male No Health Immunization Management Individuals or Households 321 482 0

MFS-IP Follow-up Survey- (9/18 month)Female No Health Immunization Management Individuals or Households 489 734 0

MFS-IP Follow up Survey- 34 months-Male No Health Immunization Management Individuals or Households 463 695 0

MFS-IP Follow up survey-(34 month) Female No Health Immunization Management Individuals or Households 463 695 0

2012-08-21-04:00

0990-0360 201309-0990-002 0990
             
        "Girls at Greater Risk for Juvenile Delinquency and HIV Prevention Program"
             
          
        
The primary goal of OWH's Girls at Greater Risk program is to increase knowledge about HIV and other sexually transmitted infections (STIs) and individual protective factors against juvenile delinquency among girls between the ages of 9 and 17 years using gender responsive prevention strategies. The program targets those behaviors and attitudes that have been found to promote both juvenile delinquency and sexually risky behavior. 2016-09-30-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 2211 3652 0

Program Participants (girl and female adolescents) No Health Illness Prevention Individuals or Households 1500 3000 0

Parents of Program Partcipants - Focus Group No Health Illness Prevention Individuals or Households 120 180 0

Program Participants Focus Group (Girls and Female Adolescents) No Health Illness Prevention Individuals or Households 120 180 0

test No Health Illness Prevention Individuals or Households 1 1 0

Program Staff- Process Evaluation Interview No Health Illness Prevention Individuals or Households 20 15 0

Program Directors- Process Evaluation Interview: Program Directors No Health Illness Prevention Individuals or Households 20 30 0

Program Partners- Process Interviews No Health Illness Prevention Individuals or Households 60 45 0

Program Partners - Focus group No Health Illness Prevention Individuals or Households 120 180 0

Community Residents No Health Illness Prevention Individuals or Households 250 21 0

2013-09-30-04:00

0990-0371 201107-0990-004 0990
             
        "Evaluation of SAMHSA Primary Care Behavioral Health Integration Grant Program"
             
          
        
SAMHSA's PBHCI grantees have been developing and implementing an array of integrated services designed to improve the physical and behavioral health status of people with serious mental illnesses, including individuals with co-occurring substance use disorders. These services incorporate a prevention and wellness approach and are provided using different models of cooperation and collaboration between community behavioral health and primary care. 2014-09-30-04:00 Active Sherrette Funn-Coleman 2026905683 Yes Yes No 59865 10057 0

SMI Clients -Client Exam and Survey-Baseline No Health Illness Prevention Individuals or Households 1000 750 0

Grantee Leadership (Sites Visit Interview) No Health Illness Prevention Individuals or Households 40 80 0

Grantee PH Providers- Site Visit Interview No Health Illness Prevention Individuals or Households 40 60 0

MH Provider Interview No Health Illness Prevention Individuals or Households 40 40 0

Care coordinators interivew No Health Illness Prevention Individuals or Households 20 30 0

Control Site leadership - Site visit Interview No Health Illness Prevention Individuals or Households 50 100 0

Grantee Data Staff -TRAC Indicators No Health Illness Prevention Individuals or Households 56000 4667 0

Grantee Data - Individual Service Utilization Data No Health Illness Prevention Individuals or Households 224 1792 0

Grantee Project Directors- Quarterly Reports No Health Illness Prevention Individuals or Households 224 448 0

SMI Clients- Clients Exam and Survey-Follow-up No Health Immunization Management Individuals or Households 1667 1250 0

Grantee Key Staff- Web Survey No Health Immunization Management Individuals or Households 560 840 0

2011-09-25-04:00

0990-0375 201011-0990-007 0990
             
        "Evaluation of Pregnancy Prevention Approaches:Implementation Study Data Collection"
             
          
        
The objective of the PPA evaluation is to test selected promising approaches to prevent teen pregnancy among middle school- and high school-aged teens. The evaluation will help OAH and ACF determine the effectiveness of various approaches in affecting key outcomes related to pregnancy prevention (for example, sexual debut, pregnancy, and sexually transmitted disease [STD] infection). Ultimately, the purpose of the evaluation is to provide stakeholders--including practitioners and federal and other policymakers--with information on approaches that hold promise for preventing teen pregnancy, and the effectiveness of these approaches. 2014-04-30-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 360 516 0

Staff and community member interview (Master Topic Guide) No Health Illness Prevention Individuals or Households 48 72 0

Guide for Focus Group Discusion w/Frontline Staff No Health Illness Prevention Individuals or Households 48 72 0

Guide for Focus Group Discussion w/Participating Youths No Health Illness Prevention Individuals or Households 216 324 0

Guide for Discussion with Control Group No Health Illness Prevention Individuals or Households 48 48 0

2011-04-07-04:00

0990-0377 201106-0990-004 0990
             
        "Request to Solicit Public Input to Nominate Non-federal Health and Health Care Data Sets and Applications For Listing on Healthdata.gov"
             
          
        
As a means to improve health and health care performance, the U.S. Department of Health and Human Services (HHS), as part of the Administration's Open Government Initiative, has been making federal data sets on health indicators available to data.gov. Through access to these datasets, users are able to develop applications of the data and apply them to a broad variety of challenges and opportunities to improve health and health care at the community level. 2014-07-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 40 10 0

Data specialist/technolgist from public government individuals, private No Health Illness Prevention
0990 OS Yes Yes Fillable Fileable Form Datasource Pg3.png 0990 OS Yes Yes Fillable Fileable Form Datasource Pg2.png 0990 OS Yes Yes Fillable Fileable Form Datasource Pg1.png 0990 OS Yes Yes Fillable Fileable Form 0990 O Yes Yes Fillable Fileable Form 0990 OS Yes Yes Fillable Fileable Form 0990 OS Yes Yes Fillable Fileable Form 0990 OS Yes Yes Fillable Fileable Form 0990 OS Yes Yes Fillable Fileable Form 0990 OS Yes Yes Fillable Fileable Form Tools Pg3.png 0990- OS Yes Yes Fillable Fileable Form 0990 OS Yes Yes Fillable Fileable Form Tools Pg2.png 0990 OS Yes Yes Fillable Fileable Form PRA V2.png 0990 OS Yes Yes Fillable Fileable Form Tools Pg1.png
Individuals or Households 40 10 0

2011-07-18-04:00

0990-0379 201106-0990-001 0990
             
        "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery"
             
          
        
This collection of information is necessary to enable HHS to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with HHS programs. 2014-07-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 1000000 67000 0

Provide Services for the Dissemination of CER to Patients and Providers to Increas Adoption- Gutcheck Website Usability Survey No Health Illness Prevention Individuals or Households 4750 238 0

Comparative Effectiveness Research Inventory No Health Illness Prevention Individuals or Households 500 125 0

Healthcare.gov Visitor Satisfaction Survey No Health Illness Prevention Individuals or Households 6000 167 0

StopBullying.gov Website Visitor Satisfaction Survey No Community and Social Services Social Services Individuals or Households 6000 167 0

HHS.gov Website Visitor Satisfaction Survey No Health Illness Prevention Individuals or Households 6000 167 0

National Women's Health Week No Health Illness Prevention Individuals or Households 1000 250 0

In Person Training/Computer-Based Training No Health Illness Prevention Individuals or Households 330 28 0

Survey Quick Health Data online No Health Illness Prevention Individuals or Households 500 42 0

OPEO Webinar Customer Satisfaction Survey No Health Illness Prevention State, Local, and Tribal Governments 250 21 0

Vaccines.gov Website Visitor Satisfaction Survey No Community and Social Services Social Services Individuals or Households 6000 167 0

Flu.gov Website Visitor Satisfaction Survey No Community and Social Services Social Services Individuals or Households 6000 167 0

FoodSafety.gov Website Visitor Satisfaction Survey No Community and Social Services Social Services Individuals or Households 6000 167 0

A Public Health Response to Trauma: Creating Conditions, Connection and Community for Women and Families No Community and Social Services Social Services State, Local, and Tribal Governments 60 40 0

eConsent Evaluation Survey No Health Public Health Monitoring Individuals or Households 2505 125 0

BeTobaccoFree.gov Website Satisfaction Survey No Community and Social Services Social Services Individuals or Households 6000 167 0

StopMedicareFraud.gov Website Satisfaction Survey No Community and Social Services Social Services Individuals or Households 6000 167 0

Usability.gov Website Visitor Satisfaction Survey No Community and Social Services Social Services Individuals or Households 1000 83 0

HHS.gov Developer Online Customer Feedback No Community and Social Services Social Services Individuals or Households 5000 83 0

Usability.gov Customer Satisfaction Survey No Community and Social Services Social Services Individuals or Households 6000 167 0

MentalHealth.gov Website Visitor Satisfaction Survey No Community and Social Services Social Services Individuals or Households 6000 167 0

Usability.gov Post Release Feedback Survey No Community and Social Services Social Services Individuals or Households 1000 83 0

HHS.gov Online Visitor Survey for Mobile and Accessibility No Community and Social Services Social Services Individuals or Households 5000 1250 0

HHS HealthBeat Visitor Survey No Community and Social Services Social Services Individuals or Households 2000 167 0

Healthy People.gov Users: Private Sector/State, Local or Tribal Governments/Federal Government No Health Illness Prevention Individuals or Households 80 27 0

2011-07-21-04:00

0990-0381 201105-0990-004 0990
             
        "Comparative Effectiveness Research: Portfolio"
             
          
        
Researchers and policymakers have emphasized the need for research on effectiveness of health care interventions under real-world conditions in diverse populations and clinical practice settings, that is, CER. The hoped-for impact of ARRA CER initiatives is the development of more and better clinical evidence that will foster fundamental change in how evidence is used in clinical practice and Assessment of American Recovery and Reinvestment Act (ARRA) comparative Effectiveness Research (ACERE)2 promote greater value in the health care system. For this evaluation, ASPE seeks to understand whether initial investments appear to be accomplishing their goals and help policymakers set a course that will achieve these long-term benefits. 2014-08-31-04:00 Active Sherrette Funn-Coleman 2026905683 Yes No No 4560 1493 0

Principal Investigators and project directors No Health Consumer Health and Safety Private Sector 730 243 0

Principal Investigators and project directors (In-depth Interviews(PSLA) No Health Consumer Health and Safety Private Sector 50 50 0

Key Stakeholders: Healthcare providers(Survey SSLA) No Health Consumer Health and Safety Private Sector 1200 300 0

Key Stakeholders: Healthcare organization adminstrators (Survey SSLA) No Health Consumer Health and Safety Private Sector 1200 300 0

Key Stakeholders: Patients/Consumers (Survey SSLA) No Health Consumer Health and Safety Private Sector 1200 300 0

Memeber of the general public -Focus Group (SSLA) No Health Consumer Health and Safety Private Sector 120 240 0

Stakeholders: health care providers (In-depth interviews (SSLA) No Health Consumer Health and Safety Private Sector 10 10 0

Stakeholders: healthcare organization administrator (In-depth interview) No Health Consumer Health and Safety Private Sector 10 10 0

Stakeholders: patient/consumer (In-depth interview) No Health Consumer Health and Safety Private Sector 10 10 0

Stakeholders: employers and payers (In-depth interview) No Health Consumer Health and Safety Private Sector 10 10 0

Stakeholders :Researchers (In-depth interview) No Health Consumer Health and Safety Private Sector 10 10 0

Stakeholders: developers of health innovations (In-depth interview) No Health Consumer Health and Safety Private Sector 10 10 0

2011-08-25-04:00

0990-0382 201203-0990-004 0990
             
        "Evaluation of Pregnancy Prevention Approaches - First Follow-up"
             
          
        
The Administration for Children & Families (ACF) of the U.S. Department of Health and Human Services (HHS) is conducting the Evaluation of Adolescent Pregnancy Prevention Approaches (PPA), an eight-year demonstration designed to study the effectiveness of promising policy-relevant strategies to reduce teen pregnancy. This package is for the first follow-up data collection. 2015-05-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 5786 3675 0

Chicago Public Schools No Health Illness Prevention Individuals or Households 1308 785 0

Oklahoma Institute Child Advocacy (OICA) No Health Illness Prevention Individuals or Households 612 428 0

Ohio Health/T.O.P.P. No Health Illness Prevention Individuals or Households 510 357 0

Children Hopital of Los Angeles/Project AIM No Health Illness Prevention Individuals or Households 906 544 0

Engender Health No Health Illness Prevention Individuals or Households 638 383 0

Live the Life Ministries/WAIT Training No Health Illness Prevention Individuals or Households 906 634 0

Princeton Center for Leadership Training /TeenPEP No Health Illness Prevention Individuals or Households 906 544 0

2012-05-15-04:00

0990-0384 201110-0990-006 0990
             
        "CHIPRA_ Children Health Insurance"
             
          
        
The Children's Health Insurance Program Reauthorization Act (CHIPRA) 10--State Evaluation will provide the federal government with new and detailed insights into how the Children's Health Insurance Program (CHIP) has evolved since its early years, what impacts on children's coverage and access to care have occurred, and what new issues have arisen as a result of policy changes related to CHIPRA and the Patient Protection and Affordable Care Act (PPACA) of 2010 (PL 111-148). 2014-12-31-05:00 Active Sherrette Funn-Coleman 2026905683 No Yes No 20040 10530 0

CHIP/Medicaid Enrollees and Disenrollees No Health Illness Prevention Individuals or Households 19500 9750 0

Medicaid Enrollees and Disenrolles No Health Illness Prevention Individuals or Households 0 0 0

CHIP and Medicaid Personnel No Health Illness Prevention Individuals or Households 300 300 0

Parents and other family members of Children (focus group) No Health Illness Prevention Individuals or Households 240 480 0

2011-12-12-05:00

0990-0385 201107-0990-002 0990
             
        "Multi-Component Evaluation of the Bodyworks Program"
             
          
        
This is a study of the BodyWorks program, which is a federally funded program that is designed to help the parents of adolescents make healthy food choices and become more physically active. The program focuses on parents as role models and provides them with hands-on tools to make small, specific behavior changes by improving family eating and activity habits to prevent obesity among their children and help them achieve or maintain a healthy weight. 2014-12-31-05:00 Active Sherrette Funn-Coleman 2026905683 No No No 6411 1409 0

Bodyworks program particpants(Parent/Caregiver Follow-up Study Questionnaire) No Health Illness Prevention Individuals or Households 450 75 0

Bodyworks program particpants(Parent/Caregiver Followup Study Focus Group) No Health Illness Prevention Individuals or Households 18 18 0

Bodyworks program particpants(English & Spanish Participant Exit Survey-Post Only Pilot Study) No Health Illness Prevention Individuals or Households 100 17 0

Bodyworks program particpants(ENGLISH & SPANISH Pretest Evaluation) No Health Illness Prevention Individuals or Households 408 136 0

Bodyworks program particpants(english and spanish posttest No Health Illness Prevention Individuals or Households 300 100 0

Bodyworks program particpants-English and Spanish Follow ups No Health Illness Prevention Individuals or Households 256 85 0

Bodyworks program particpants -Feedback forms No Health Illness Prevention Individuals or Households 2400 200 0

English and Spanish Bodywork Program comparison group participant-pretest No Health Illness Prevention Individuals or Households 408 136 0

English and Spanish Bodywork Program comparison group participant-posttest No Health Illness Prevention Individuals or Households 300 100 0

English and Spanish Bodywork Program comparison group participant-Follow-up No Health Illness Prevention Individuals or Households 256 85 0

Trainers of the Bodyworks Program-Follow up study questionnaire No Health Illness Prevention Individuals or Households 1250 417 0

Trainers of the Bodyworks program-Follow-up study interview No Health Illness Prevention Individuals or Households 15 15 0

Trainers of the Bodyworks program-Exit survey satisfaction interview No Health Illness Prevention Individuals or Households 10 5 0

Trainers of the Bodyworks program- trainer feedback forms No Health Illness Prevention
0990 survey Yes Yes Fillable Printable Form 0990-BodyWorks_Full Evaluation_Trainer Feedback Form.doc
Individuals or Households 240 20 0

2011-12-12-05:00

0990-0387 201108-0990-003 0990
             
        "Wellness Program Study"
             
          
        
This data collection will be used to describe the existing use of wellness programs, including any related incentives provided to employees; examine the effectiveness of premium-based and cost-sharing incentives and other types of rewards on program participation and health behavior; and assess the impact of wellness programs on affordability of coverage and access to care, health behavior, and health outcomes. 2015-01-31-05:00 Active Sherrette Funn-Coleman 2026905683 No Yes No 3068 1587 0

Human Resource Manager No Health Illness Prevention Federal Government 3000 1500 0

Employees in All Occupations No Health Illness Prevention Federal Government 48 72 0

Human Resource Manager (Key Informant Interview) No Health Illness Prevention Federal Government 20 15 0

2012-01-12-05:00

0990-0388 201206-0990-001 0990
             
        "Baseline Let's Move! Cities, Towns and Counties Participant Survey"
             
          
        
The survey requests information about the activities the locality is choosing to undertake. The responses to these questions will be used to show progress and successes over time for localities participating in Let's Move! Cities, Towns, and Counties, as well as how HHS can adjust its technical assistance in response to localities'progress. This initiative was launched preliminarily in the spring of 2010, and is being re-launched in January of 2011. 2015-07-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 1000 250 0

Government Official (city, town, county) No Health Illness Prevention Individuals or Households 1000 250 0

2012-07-02-04:00

0990-0389 201110-0990-004 0990
             
        "Outcome Evaluation of "Teenage Pregnancy Prevention:Intergrating Services, Programs, and Strategies through Community-Wide Intitatives""
             
          
        
The main objective for the proposed Outcome Evaluation of Teenage Pregnancy Prevention: Integrating Services, Programs, and Strategies through Community-wide Initiatives is to measure risk behaviors, pregnancies, and use of contraceptives and family planning services among youth. 2015-02-28-05:00 Active Sherrette Funn-Coleman 2026905683 No No No 6000 4500 0

Evaluation of Adolescent Pregnancy Prevention Approaches Household (Modified PPA) Survey No Health Illness Prevention Individuals or Households 6000 4500 0

2012-02-22-05:00

0990-0390 201111-0990-001 0990
             
        "Generic: Challenge and Competition solicitations "
             
          
        
The request is being sought so as to implement the uses of Challenge competitions as a means to promote innovative solutions to the problems and needs confronting DHHS. The approval seeks to enable specific information necessary to perform the evaluation of solutions provided by individuals and/or organizations requested by the Federal government. 2015-02-28-05:00 Active Sherrette Funn-Coleman 2026905683 No No No 1530 251 0

Managing Meds Video Contest No Health Public Health Monitoring
1 Video Meds Application Yes Yes Fillable Fileable Form and instruction Screenshot_Application_Video Contest.JPG
Individuals or Households 100 17 0

2012-02-29-05:00

0990-0391 201203-0990-001 0990
             
        "The Hospital Preparedness Program"
             
          
        
GenIC approved under this generic clearance will be used to monitor awardees' compliance with program requirements and for the development of selected healthcare preparedness capabilities. 2015-03-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 186 14973 0

EOY No Health Immunization Management State, Local, and Tribal Governments 62 1550 0

MY No Health Immunization Management State, Local, and Tribal Governments 62 1550 0

Healthcare Coalition Questionnaire No Health Health Care Services Private Sector 62 62 0

Local and State Health Department Involvement wit Health Care Coalitions (HCCs) No Health Illness Prevention State, Local, and Tribal Governments 64 96 0

2012-03-28-04:00

0990-0392 201305-0990-001 0990
             
        "ACYF Pregnancy Prevention Performance Measure Collection"
             
          
        
The performance measure collection is important to OAH and ACYF because it will provide the agency with data both to both effectively manage the TPP and PREIS programs, and to comply with accountability and federal performance requirements for the 1993 Government Performance and Results Act (P.L. 103-62). Moreover, collecting and reporting on data for performance measures are a funding requirement for the grants, as stated in the funding opportunity announcement. 2015-05-31-04:00 Active Sherrette Funn-Coleman 2026905683 No Yes No 50868 7197 0

Grantee program staff No Health Illness Prevention Individuals or Households 214 856 0

Youth Participating in programs No Health Illness Prevention Individuals or Households 50547 4212 0

Grantee program staff-Tier 1 A/B No Health Illness Prevention Individuals or Households 59 1121 0

Grantee Program staff-Tier 1 C/D and Ter 2/PREIS No Health Illness Prevention Individuals or Households 48 1008 0

2013-05-31-04:00

0990-0393 201204-0990-001 0990
             
        "Evaluation of the Consumer Education Campaign "Make the Call-Don't Miss a Beat" "
             
          
        
The purpose of this study is to conduct evaluative research on the "Make the Call. Don't Miss a Beat" campaign. This is a national Public Service Announcement (PSA) campaign that aims to educate, engage and empower women and their families to learn the seven most common symptoms of a heart attack and to call 911 as soon as those symptoms arise. The evaluation will assess the likely effectiveness of consumer communication, particularly with women over 50. 2015-05-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 5500 223 0

General Population, Adult Women, 25 + No Health Illness Prevention Individuals or Households 4300 143 0

Main Instrument- General Population, Adult Women, 25+ No Health Illness Prevention Individuals or Households 1200 80 0

2012-05-10-04:00

0990-0394 201201-0990-004 0990
             
        "Teen Pregnancy Prevention Replication Evaluation: Baseline Data "
             
          
        
OAH, in collaboration with ASPE, is conducting the TPP Replication Study evaluation, which is specifically designed to determine whether the replications of evidence-based program models, funded as part of the OAH evidence-based Teen Pregnancy Prevention Program, are effective in preventing teen pregnancy, reducing sexually transmitted infections, and/or preventing or reducing sexual risk behaviors. This evaluation focuses on the replication of a small number of program models across multiple sites with the goals of determining the extent to which program impacts are replicated as well as addressing questions about the extent to which aspects of program implementation are associated with program impacts. 2015-06-30-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 8551 2139 0

Sexuallly Active Youth Part A Safer Sex No Health Illness Prevention Individuals or Households 1425 356 0

Part A Reducing the Risk and Cuidate No Health Illness Prevention Individuals or Households 2850 713 0

B1 Safer Sex sites and youth who have ever had sex No Health Illness Prevention Individuals or Households 2138 535 0

Non Sexually active youth Part B2 of the baseline survey to be used with youth who have No Health Illness Prevention Individuals or Households 2138 535 0

2012-06-08-04:00

0990-0395 201202-0990-001 0990
             
        "Cross-site Evaluation of the Minority Serving Institutions' HIV/AIDS Demonstration Initiative and Capacity Building Project"
             
          
        
The data collected in this cross-site evaluation will provide information about the effectiveness of different approaches to HIV/AIDS prevention, including numbers of students reached and engaged, changes in knowledge and awareness of HIV/AIDS, and behaviors related to prevention, testing and treatment. The data collected will also be used to identify best practices that offer the greatest promise for sustained effectiveness and expansion to other minority youth. 2015-06-30-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 3114 2652 0

Annual Staff Key Informant interview MSI staff No Health Illness Prevention Individuals or Households 14 56 0

Monthly Progress Reports MSI HIV staff No Health Illness Prevention Individuals or Households 168 168 0

Semi-Annual Reporting of Site Evaluation Findings MSI HIV staff No Health Illness Prevention Individuals or Households 28 140 0

Annual Site Visit Partner Key Informant Interview No Health Illness Prevention Individuals or Households 14 28 0

Pre-and Post Surveys Students No Health Illness Prevention Individuals or Households 2000 2000 0

Pre-Post Test Students No Health Illness Prevention Individuals or Households 840 210 0

Focus Groups\Interviews No Health Illness Prevention Individuals or Households 50 50 0

2012-06-11-04:00

0990-0396 201111-0990-002 0990
             
        "Multisite Evaluation of the In Community Spirit Program - Prevention of HIV/AIDS for Native/American Indian and Alaska Native Women Living in Rural and Frontier Indian Country"
             
          
        
The In Community Spirit Program is designed to increase HIV prevention knowledge and reduce the risk of contracting HIV among American Indian and Alaska Native women. The program has three components (prevention education, community awareness, and capacity building) and is implemented through six cooperative agreements. The evaluation of the In Community Spirit Program is multi-component, culturally competent, and multi-site. The evaluation includes key informant interviews with program staff and service providers to understand the facilitators and barriers of HIV prevention education, outreach and awareness, and capacity building across grantee programs as well as sustainability efforts related to these activities. The evaluation also includes surveys to be administered at pre, post, and 3 month follow up of an adapted, gender-based HIV prevention curriculum. The surveys examine women's knowledge, attitudes, awareness, and behaviors related to HIV and its prevention as well as stigma related to HIV testing and knowledge of testing sites. Because of the lack of information on evidence based practices for American Indian and Alaska Native women, this evaluation provides an opportunity to collect meaningful data on adapting existing evidence based practices to this population. Data gathered through the evaluation will be used to understand the extent to which the In Community Spirit Program has been able to achieve its goals and will enrich understandings of the way in which innovative programs impact quality and access to HIV prevention and intervention services for American Indian and Alaska Native women. 2015-06-30-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 1860 500 0

Health Educators No Health Illness Prevention Individuals or Households 12 10 0

Healthcare support workers No Health Illness Prevention Individuals or Households 48 40 0

Community Member No Health Illness Prevention Individuals or Households 1800 450 0

2012-06-29-04:00

0990-0397 201201-0990-003 0990
             
        "Teen Pregnancy Prevention Replication Evaluation: Replication Study"
             
          
        
OAH, in collaboration with ASPE, is conducting the TPP Replication Study evaluation, which is specifically designed to determine whether the replications of evidence-based program models, funded as part of the OAH evidence-based Teen Pregnancy Prevention Program, are effective in preventing teen pregnancy, reducing sexually transmitted infections, and/or preventing or reducing sexual risk behaviors. This evaluation focuses on the replication of a small number of program models across multiple sites with the goals of determining the extent to which program impacts are replicated as well as addressing questions about the extent to which aspects of program implementation are associated with program impacts. 2015-07-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 310 420 0

Grantee Heads No Health Illness Prevention Individuals or Households 10 15 0

Guide for Directors No Health Illness Prevention Individuals or Households 10 15 0

Guide for Supervisor of frontline staff No Health Illness Prevention Individuals or Households 10 15 0

Guide for frontline staff No Health Illness Prevention Individuals or Households 30 45 0

guide for community partners No Health Illness Prevention Individuals or Households 30 30 0

guide for school stakeholders No Health Illness Prevention Individuals or Households 30 30 0

Guide for community stakeholder No Health Illness Prevention Individuals or Households 30 30 0

Focus Group Guide for frontline No Health Illness Prevention Individuals or Households 60 90 0

Focus Group for the youth No Health Illness Prevention Individuals or Households 100 150 0

2012-07-03-04:00

0990-0399 201207-0990-006 0990
             
        "Evaluation of the Effectiveness of an Educational Interactive Video on Research Integrity"
             
          
        
The Office of the Assistant Secretary for Health (OASH) and specifically the Office of Research Integrity (ORI), requests approval for a new data collection to examine the effectiveness of an educational interactive video on research integrity. 2015-07-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 6000 2100 0

Survey No Health Consumer Health and Safety Individuals or Households 6000 2100 0

2012-07-31-04:00

0990-0400 201204-0990-004 0990
             
        "CHIPRA-Children's Health Insurance Program Reauthorization Act of 2009 -ELE"
             
          
        
As part of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Congress authorized a new policy known as Express Lane Eligibility (ELE). With ELE, a state's Medicaid and/or Children's Health Insurance Program (CHIP) can rely on another agency's eligibility findings to qualify children for CHIP or Medicaid health coverage, despite their different methods of assessing income or otherwise determining eligibility. As part of CHIPRA, Congress also mandated an extensive, rigorous evaluation of ELE, creating an exceptional opportunity to document ELE implementation across states and to assess the changes to coverage or administrative costs that may have resulted. The evaluation also provides an opportunity to understand other methods of simplified enrollment that states have been pursuing and to assess the benefits and potential costs of these methods compared to those of ELE. 2015-08-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 692 1051 0

Staff for Administrative Cost Data Collection No Health Illness Prevention Individuals or Households 18 27 0

Staff for Enrollment Data Collection No Health Illness Prevention State, Local, and Tribal Governments 6 240 0

State - Level Key Informants- ELE States No Health Illness Prevention State, Local, and Tribal Governments 120 120 0

Local - Level Key Informant (ELE) No Health Illness Prevention State, Local, and Tribal Governments 90 90 0

Moderator"s Guide No Health Illness Prevention State, Local, and Tribal Governments 240 480 0

Medicaid and CHIP Officials No Health Illness Prevention State, Local, and Tribal Governments 68 34 0

Key Informants (Quarterly Monitoring Calls) No Health Illness Prevention State, Local, and Tribal Governments 150 60 0

2012-08-13-04:00

0990-0401 201206-0990-004 0990
             
        "Campaign Within the Latino Community on Right to Non-Discrimination in Certain Health and Human Service Programs"
             
          
        
The purpose of the contract is to conduct a campaign to reach adult Latino patients and caregivers, including those with Limited English Proficiency (LEP) in order to: 1.Examine attitudes toward, and experience with discrimination in health care. 2. Increase patient awareness of what constitutes discrimination in health care. 3. Inform patients of what they should do and whom they should contact should they ever experience discrimination in health care. 4. Study effective ways to lessen discrimination against Latinos by health care providers. 2015-08-31-04:00 Active Keith Tucker keith.tucker@hhs.gov 202 260-5965 No No No 660 214 0

Screening for focus group sessions No Health Illness Prevention Individuals or Households 40 4 0

Focus Group Session No Health Illness Prevention Individuals or Households 20 40 0

We-based interviews No Health Illness Prevention Individuals or Households 600 170 0

2012-08-15-04:00

0990-0402 201207-0990-005 0990
             
        "Patient Centered Care Collaboration to Improve Minority Health Project"
             
          
        
The intent of this effort is to help facilitate and inform future adoption of evidence-based comparative effectiveness research (CER) findings. While not a program evaluation per se, the goal of this project is to improve our understanding of what is necessary to facilitate the dissemination of evidence-based Comparative Effectiveness Research. To that end, a case study methodology is being employed to address the study objectives using focus groups, surveys, and key informant interviews. 2015-08-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 1584 802 0

Screening Questionnaire No Health Illness Prevention Individuals or Households 0 0 0

Intake Questionnaire HELP No Health Illness Prevention Individuals or Households 0 0 0

Pst-Intervention Questionnaire No Health Illness Prevention Individuals or Households 0 0 0

Houston: Eligibility Screening Form1:Hpertension and Diabetes No Health Illness Prevention Individuals or Households 0 0 0

First Home Visit Form: Diabetes or Hypertension or Hypertension and Diabetes No Health Illness Prevention Individuals or Households 0 0 0

Telephone Follow-up; Being Active and Managing Stress No Health Illness Prevention Individuals or Households 0 0 0

Telephone Follow-up: Healthy Eating No Health Illness Prevention Individuals or Households 0 0 0

Post Intervention: Diabetes or Hpertension or Hperteension and Diabetes No Health Illness Prevention Individuals or Households 0 0 0

Chicago-Participants, Implementation Staff, Local Hub Members No Health Illness Prevention Individuals or Households 459 247 0

Houston- Participant,Provider, Facility Administrator, Local Hub. Steering Committee Members No Health Illness Prevention Individuals or Households 1125 555 0

2012-08-31-04:00

0990-0403 201207-0990-003 0990
             
        "Survey of Primary Care Physicians on Oral Health"
             
          
        
This survey will provide knowledge about primary care physicians that could be used by HHS or other entities to inform initiatives designed to improve the quality of care delivered to adult patients and increase collaborative efforts among dentists and physicians. Published manuscripts will add depth to the peer-reviewed scientific literature with regard to the extent that the evidence base has been adopted into practice. If there is a need to educate primary care physicians on oral health, a window of opportunity currently exists under the HHS Oral Health Initiative to engage in a cross-collaborative federal effort. 2015-11-30-05:00 Active Sherrette Funn-Coleman 2026905683 No No No 1900 308 0

Medical Secretary No Health Illness Prevention Private Sector 1300 108 0

Physician No Health Illness Prevention Private Sector 600 200 0

2012-11-07-05:00

0990-0404 201209-0990-002 0990
             
        "Children's Health Insurance Program Reauthorization Act (CHIPRA) 10-State Evaluation, Telephone Interviews with State CHIP Program Administrators"
             
          
        
The Children's Health Insurance Program Reauthorization Act (CHIPRA) 10-State Evaluation will provide the federal government with new and detailed insights into how the Children's Health Insurance Program (CHIP) has evolved since its early years, what impacts on children's coverage and access to care have occurred, and what new issues have arisen as a result of policy changes related to CHIPRA and the Patient Protection and Affordable Care Act (Affordable Care Act) of 2010 (PL 111-148). 2015-11-30-05:00 Active Wilma Robinson wilma.robinson@hhs.gov 202 205-8841 No No No 77 77 0

Telephone Interview Discussion Guide No Community and Social Services Social Services State, Local, and Tribal Governments 77 77 0

2012-11-26-05:00

0990-0405 201212-0990-001 0990
             
        "TPP Replication Study Follow Up Data Collection"
             
          
        
HHS is interested in identifying and evaluating approaches to reduce teen pregnancy, associated risk behaviors, and their consequences. One of the key policy questions is whether programs that have demonstrated evidence of effectiveness can be replicated in new settings with positive impacts. Of the 31 programs on the HHS list of evidence-based programs, only one program model has been replicated and shown to have positive effects through a rigorous evaluation. The follow-up data collection described in this ICR will provide important information to guide policy decisions aimed at replicating evidence-based programs. 2016-03-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 11400 5700 13544

Safer Sex Intervention Survey No Health Consumer Health and Safety
1 Safer Sex Intervention Survey Yes Yes Fillable Fileable Form and instruction TPP Replication Study Follow-Up Survey Attachment D - SSI.docx
Individuals or Households 3800 1900 12398

Reducing the Risk - Active Youth No Health Consumer Health and Safety
2 Reducing the Risk - Active Yes Yes Fillable Fileable Form and instruction TPP Replication Study Follow-Up Survey Attachment E - RtR_Cuidate Sexually Active.docx
Individuals or Households 3800 1900 457

Reducing the Risk - Inexperienced No Health Consumer Health and Safety
3 Reducing the Risk - Inexperienced Yes Yes Fillable Fileable Form and instruction TPP Replication Study Follow-Up Survey Attachment F - RtR_Cuidate Sexually Inexperienced.docx
Individuals or Households 3800 1900 689

2013-03-01-05:00

0990-0406 201307-0990-001 0990
             
        "Evaluation of the National Partnership for Action to End Health Disparities"
             
          
        
OMH sought to establish the priorities for a national strategy using a community-oriented approach. The result is the National Stakeholder Strategy for Achieving Health Equity (National Stakeholder Strategy). It is a roadmap for eliminating health disparities through cooperative and strategic action. Blueprints for Action will align with the National Stakeholder Strategy to help guide action at the local, state, and regional levels. There will be blueprints for the 10 HHS regions. Targeted initiatives will be organized by partners in the public and private sectors in support of the NPA. 2016-04-30-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 545 263 0

RHEC co-chairs interview No Health Illness Prevention Individuals or Households 20 28 0

RHEC Subcommittee chairs group interviews No Health Illness Prevention Individuals or Households 50 75 0

RHEC Members No Health Illness Prevention Individuals or Households 350 117 0

Key NPA partner organizations No Health Illness Prevention Individuals or Households 15 6 0

State Minority Health Office Directors/Coordinators and State Department of Health Representatives No Health Illness Prevention Individuals or Households 110 37 0

2013-07-31-04:00

0990-0407 201301-0990-001 0990
             
        "OS Think Cultural Health"
             
          
        
The Office of Minority Health (OMH), Office of the Secretary (OS), Department of Health and Human Services (HHS) is requesting approval from OMB for the registration component of the Think Cultural Health (TCH) website program. The TCH website is used to post information such as cultural competency, language access and health disparities articles, and notices of health disparities conferences for visitors to the site. Users must be registered to participate. 2016-04-30-04:00 Active Sherrette Funn-Coleman 2026905683 No Yes No 118692 5936 0

Physician No Health Illness Prevention Individuals or Households 27477 1374 0

Nurse No Health Illness Prevention Individuals or Households 44723 2236 0

Physician Assistant No Health Illness Prevention Individuals or Households 1882 94 0

Dentist No Health Illness Prevention Individuals or Households 377 19 0

Dental Professional No Health Illness Prevention Individuals or Households 39 2 0

Social Worker No Health Illness Prevention Individuals or Households 1733 87 0

public Health No Health Illness Prevention Individuals or Households 186 9 0

General Healthcare Worker No Health Illness Prevention Individuals or Households 12635 632 0

Psycologist/Psychiatrist No Health Illness Prevention Individuals or Households 189 9 0

Mental Health Professional No Health Illness Prevention Individuals or Households 180 9 0

Pharmacist, RPH No Health Illness Prevention Individuals or Households 750 38 0

Emergency Medical Technician No Health Illness Prevention Individuals or Households 492 25 0

Administrator or Hospital Executive No Health Illness Prevention Individuals or Households 151 8 0

Policymaker or Public Official No Health Illness Prevention Individuals or Households 17 1 0

Teacher No Health Illness Prevention Individuals or Households 424 21 0

Lawyer No Health Illness Prevention Individuals or Households 107 5 0

Bachelors No Health Illness Prevention Individuals or Households 3753 188 0

Masters No Health Illness Prevention Individuals or Households 4063 203 0

Doctorate No Health Illness Prevention Individuals or Households 1130 57 0

Student No Health Illness Prevention Individuals or Households 7504 375 0

other No Health Illness Prevention Individuals or Households 10880 544 0

2013-04-01-04:00

0990-0408 201304-0990-001 0990
             
        "Evaluation of Implementation of the Viral Hepatitis Action Plan"
             
          
        
The purpose of the evaluation is to help HHS better understand local implementation of the Action Plan at the state and local level and any barriers or challenges that might be occurring. The results will enable HHS to identify potential strategies to strengthen local implementation of the Action Plan, address barriers, and inform future implementation efforts to help improve viral hepatitis prevention, care and treatment. 2014-05-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 68 42 0

Audlt Viral Hepatitis Prevention Coordinators No Health Illness Prevention State, Local, and Tribal Governments 4 6 0

State and Local Health Departments No Health Illness Prevention State, Local, and Tribal Governments 16 12 0

Community-based organizations No Health Illness Prevention State, Local, and Tribal Governments 12 6 0

National Organizations No Health Illness Prevention State, Local, and Tribal Governments 12 6 0

Correctional Facilities No Health Illness Prevention State, Local, and Tribal Governments 12 6 0

Healthcare providers No Health Illness Prevention State, Local, and Tribal Governments 12 6 0

2013-05-22-04:00

0990-0409 201306-0990-001 0990
             
        "Ryan White/AIDS Program Modeling Study"
             
          
        
Originally enacted in 1990 as the Ryan White Comprehensive AIDS Relief Emergency (CARE) Act, Congress has made substantial changes to the program as the HIV/AIDS epidemic has evolved (Kaiser 2006). It remains to be seen whether new changes will be considered and enacted in the next reauthorization of the program, scheduled for 2013, in anticipation of the full implementation of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) in 2014. The overall goals of the study are to project the service needs of low-income and uninsured or underinsured people living with HIV/AIDS as the provisions of the Affordable Care Act are implemented in 2014 and to identify strategies for ensuring that available federal resources are directed to areas of greatest need for HIV/AIDS care under federal health reform. 2014-07-31-04:00 Active Sherrette Funn-Coleman 2026905683 No Yes No 210 205 0

Part A Grantee No Health Illness Prevention Individuals or Households 26 28 0

Part B Grantee No Health Illness Prevention Individuals or Households 51 55 0

Provider No Health Illness Prevention Individuals or Households 133 122 0

2013-07-08-04:00

0990-0410 201307-0990-005 0990
             
        "MOVE: Making Our Vitality Evident"
             
          
        
The Office on Women's Health (OWH) and the Department of Health and Human Services (HHS) Coordinating Committee on Lesbian, Gay, Bi-sexual and Transgender (LGBT) Issues has prioritized the collection of health data on LGBT populations. The George Washington University and Whitman Walker Health Clinic's Mautner Project, a community organization that promotes the health and wellness of lesbian and bisexual women, developed "MOVE: Making Our Vitality Evident." This program responds to Goal 1, Strategy 1-2 and Goal 4, Strategy 4-1 of the 2012 IOM report on Accelerating Progress in Obesity Prevention. To achieve Strategy 1-2, two cohorts of 20 women each will participate in a 12 week curriculum that focuses on health and nutrition education, physical activity, and social support. To achieve Strategy 4-1, MOVE will conduct trainings for up to 150 providers on culturally competent care for interacting with and treating obese and overweight lesbian and bisexual patients. The MOVE intervention and evaluation is designed to target women aged 40 and older living in the Washington, D.C. metropolitan area and will last for up to one year. 2014-08-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 380 56 0

Pre-test Women's Survey No Health Illness Prevention Individuals or Households 40 15 0

Post -Test Women's Survey No Health Illness Prevention Individuals or Households 40 15 0

Pre Test Physician's nurses Survey No Health Illness Prevention Individuals or Households 150 13 0

Post Test Physician's Nurses Survey No Health Illness Prevention Individuals or Households 150 13 0

2013-08-23-04:00

0990-0411 201307-0990-004 0990
             
        "Out, Proud and Healthy Fitness Project"
             
          
        
The Office of Women's Health (OWH) and the Department of Health and Human Services (HHS) Coordinating Committee on Lesbian, Gay, Bi-sexual and Transgender (LGBT) Issues has prioritized the collection of health data on LGBT populations. In response, OWH funded an initiative to "identify and test effective and innovative ways of reducing obesity in lesbian and bisexual women" (HHS, 2012). OWH contracted with NORC and its subcontractor, the University of Missouri amp;#8211; Columbia (MU), to develop and pilot test a project entitled "Out Proud and Healthy Fitness Project (OPAH)." The intervention will promote health and fitness in lesbian and bisexual (LB) women through group support programs and community approaches tailored to sexual minority women. OPAH will address Goal 1, Make Physical Activity an Integral and Routine Part of Life, of the 2012 IOM report on Accelerating Progress in Obesity Prevention. To accomplish this, OPAH will partner with two Sexual and Gender Minority community centers in Missouri, The Center Project in Columbia and SAGE Metro St. Louis, in a randomized prevention study. Approximately 160 individuals will be enrolled in the study, for a target number of 120 individuals completing. Approximately 40-50 participants will be enrolled in each study arm (Full Gym Group, Smart Pedometer Group, and Health Education (control) Group). The active intervention phase of the project is 16 weeks (4 months). Data will be collected at Baseline, Month 4 and Month 12 (about 7 months after the completion of the intervention) through direct assessments and surveys of the participants. The project is scheduled for one year. The project will affect lesbian and bi-sexual women forty years and over. 2015-08-31-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 590 470 0

Enrollment Survey No Health Illness Prevention Individuals or Households 160 99 0

Baseline Survey No Health Illness Prevention Individuals or Households 150 150 0

4-month Follow up Assessment Survey No Health Illness Prevention Individuals or Households 140 107 0

Post Intervention Focus Group No Health Illness Prevention Individuals or Households 20 30 0

12-month Follow up Assessment Survey No Health Illness Prevention Individuals or Households 120 84 0

2013-08-29-04:00

0990-0412 201307-0990-002 0990
             
        "Doing It For Ourselves (DIFO) Program "
             
          
        
The Office of Women's Health (OWH) and the Department of Health and Human Services (HHS) Coordinating Committee on Lesbian, Gay, Bisexual and Transgender (LGBT) Issues has prioritized the collection of health data on LGBT populations. In response, OWH funded an initiative to "identify and test effective and innovative ways of reducing obesity in lesbian and bisexual women" (HHS, 2012). The Doing It For Ourselves (DIFO) program, developed in San Francisco in a community-driven collaboration, aims to test an intervention that promotes healthy weight, increased quality of life and overall well being in lesbian and bisexual (LB) women age 40 years and older. The program consists of 12 weekly group educational and support sessions, two hours of personal coaching, and web-based health resources on nutrition, physical activity, and health problems common to older sexual minority women. The program will be evaluated using a randomized step-wedge design. Women will be recruited and then randomized into a treatment a control group, which will receive a delayed treatment. The goal is to treat a total of 112 women in three parts of the Bay Area: San Francisco, the East Bay, and Santa Rosa. Program effects will be tested using pre, immediate post, and three-month post surveys. 2015-09-30-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 684 323 0

Screen ing Tool No Health Illness Prevention Individuals or Households 180 15 0

Baseline Survey No Health Illness Prevention Individuals or Households 168 84 0

Follow up Survey No Health Illness Prevention Individuals or Households 224 112 0

End of the Program Focus Group No Health Illness Prevention Individuals or Households 112 112 0

2013-09-09-04:00

0990-0413 201307-0990-003 0990
             
        "Living Healthier Living Longer Program"
             
          
        
The Department of Health and Human Services (HHS) Coordinating Committee on Lesbian, Gay, Bi-sexual and Transgender (LGBT) Issues has prioritized the collection of health data on LGBT populations. In response, OWH funded an initiative to "identify and test effective and innovative ways of reducing obesity in lesbian and bisexual women". This initiative, which will be implemented in a LBGT senior center in New York City, will include nutritional and physical fitness counseling and activities that build upon the IOM[1] Goal 1: Make physical activity an integral and routine part of life, and Goal 3: Transform messages about physical activity and nutrition. The program is based on cognitive-behavioral theory and will be tailored to overweight bisexual and lesbian women 60 years and over. The program will enroll a minimum of 40 older lesbian and bisexual women and will include 14 weekly peer-moderated sessions during which participants will engage in 10 minutes of physical activity (e.g., yoga), learn and perform a featured resistance-training exercise, learn about a featured fruit/vegetable/legume with supporting recipes, and participate in a group discussion on a pre-specified topic (e.g., goal-setting, cooking tips, exercise self-efficacy and coping mechanisms). Educational materials will accompany the weekly sessions. Participants will be provided with "Smart" pedometers that will automatically synchronize with an activated computer available at the intervention site, allowing for targeted goal setting using step counts, and online interaction among participants choosing to share their steps with others in the group. Participants will also be encouraged to participate in walking groups and other physical activity opportunities available at the senior center. Information will be gathered and analyzed with the objective of identifying and understanding the effects of this healthy weight intervention and to inform the applicability of the intervention to other sites across the United States. The project is scheduled for one year. 2015-09-30-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 360 129 0

Baseline Survey No Health Illness Prevention Individuals or Households 40 10 0

Study Completion Survey No Health Illness Prevention Individuals or Households 40 10 0

Pedometer Profile No Health Illness Prevention Individuals or Households 40 1 0

Health Screening (physical measurement) No Health Illness Prevention Individuals or Households 120 20 0

Health History (Questionnarie) No Health Illness Prevention Individuals or Households 40 8 0

Focus Group (study midpoint) No Health Illness Prevention Individuals or Households 40 40 0

Focus Study (completion) No Health Illness Prevention Individuals or Households 40 40 0

2013-09-09-04:00

0990-0414 201307-0990-006 0990
             
        "WHAM: Women Health and Mindfulness Program "
             
          
        
The Office of Women's Health (OWH) and the Department of Health and Human Services (HHS) Coordinating Committee on Lesbian, Gay, Bi-sexual and Transgender (LGBT) Issues has prioritized the collection of health data on LGBT populations. In response, OWH funded an initiative to "identify and test effective and innovative ways of reducing obesity in lesbian and bisexual women" (HHS, 2012). The Women's Health and Mindfulness (WHAM) program developed in San Francisco, aims to test interventions that promote healthy weight in lesbian and bisexual (LB) women age 40 years and older on two levels. 2015-09-30-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 560 179 0

Knowledge and attitudes assessment (Pretraining) No Health Illness Prevention Individuals or Households 40 3 0

Knowledge and Attitudes Assessment (Post-training) No Health Illness Prevention Individuals or Households 40 3 0

Group Intervention Sereening Questionnaire No Health Illness Prevention Individuals or Households 120 20 0

Evaluation Questionnaire No Health Illness Prevention Individuals or Households 80 60 0

Baseline Interim Behavioral Assessment Month No Health Illness Prevention Individuals or Households 80 13 0

Accelerometer: Activity Diary and Reminder No Health Illness Prevention Individuals or Households 40 13 0

Evaluation Questionnaire: Follow-up-month 4 No Health Illness Prevention Individuals or Households 80 40 0

Interim Behavioral Assessment Month 5 No Health Illness Prevention Individuals or Households 40 7 0

Evaluation Questionnaire: Follow-up month 8 No Health Illness Prevention Individuals or Households 40 20 0

2013-09-09-04:00

0990-0415 201306-0990-002 0990
             
        "Survey of Physician Time Use Patterns under the Medicare Fee Schedule"
             
          
        
The Office of the Assistant Secretary for Planning and Evaluation is currently conducting a number of studies aimed at producing evidence that will help to improve the accuracy of the Medicare Physician Fee Schedule. Under the Medicare Physician Fee Schedule, payments are based in part on the relative amount of physician work associated with each service. For a number of reasons, payment differentials for Evaluation and Management services relative to procedures, rather than narrowing, have continued to widen over time. While the fee schedule's relative values are updated to reflect changes in medical practice, technology and physician productivity, some have questioned whether the current process adequately reflects these changes. The intended data collection effort would be used to gather information on the time data that is used as an input in the fee schedule. 2016-09-30-04:00 Active Sherrette Funn-Coleman 2026905683 No No No 600 200 0

Primary Care No Health Illness Prevention Individuals or Households 120 40 0

Specialist No Health Illness Prevention Individuals or Households 480 160 0

2013-09-26-04:00